Abstract
Introduction
A
Continuous glucose monitor (CGM) devices continue to demonstrate benefits not only as an adjunct to structured education programs but also outside of such programs, as seen in the AH-HA! project and the hypoglycemia study. The discrepancies in results may come from the different populations that are studied, and it will be important to explore such issues more deeply in future research. Sleep, sensor inaccuracy, alarms, and factors continue to impact people's experience with closed-loop technologies, as highlighted in the study with older adults. The psychosocial and glycemic benefits overall, however, continue to outweigh the reported downsides. Device satisfaction and usability were examined in both youths and their caregivers in the context of psychosocial outcomes such as distress, well-being, hypoglycemia confidence, and sleep quality. The Omnipod tubeless system was rated highly on these outcomes among children, adolescents, and their caregivers, demonstrating the increasing acceptability of such systems and improved time-in-target range.
Downloading of data remains challenging, and health-care professionals do not always look at the information when it has been downloaded. This raises questions of how frequently data should be downloaded and who has responsibility for acting on that information. If health-care professionals believe their patients are downloading and making adjustments or diabetes-related decisions based on that data, but the patients believe they are downloading the data for their health-care professional to review and make decisions, then there is a clear gap in communication. Greater understanding is necessary to ensure that it is clear to patients how to download the data, how to interpret it, and what to do with that new information so they feel confident and competent in practice. Without clear guidance, it is unlikely that downloading will increase any time soon.
Integration of psychological services into routine care was examined among the SWEET registry centers. Although glycemic control did not improve significantly at centers where psychological support was offered, there was a significant improvement in the rates of diabetic ketoacidosis (DKA). It has long been recognized that psychological support is crucial for people living with diabetes; however, as seen in this study almost a third of centers did not provide relevant data, and of those that did, one in ten did not provide psychological support, despite the requirement to do so.
Key Articles Reviewed
Puckrein GA, Hirsch IB, Parkin CG, Taylor BT, Norman GJ, Xu L, Marrero DG
Zuijdwijk C, Courtney J, Mitsakakis N, Hayawi L, Sutherland S, Newhook D, Ahmet A, Goldbloom EB, Khatchadourian K, Lawrence S
Madhun NZ, Galindo RJ, Donato J, Hwang PR, Shabir HF, Fowler MJ, Molitch-Hou E, Bena JF, Umpierrez GE, Lansang MC
Serné EH, van den Berg IK, Racca C, van Raalte DH, Kramer MHH, de Wit M, Snoek FJ for the BIDON-Consortium Investigators
Polonsky WH, Fortmann AL, Soriano EC, Guzman SJ, Funnell MM
Palmer BA, Soltys K, Zimmerman MB, Norris AW, Tsalikian E, Tansey MJ, Pinnaro CT
Chobot A, Eckert AJ, Biester T, Corathers S, Covinhas A, de Beaufort C, Imane Z, Kim J, Malatynska A, Moravej H, Pokhrel S, Skinner T, SWEET Study Group
Kubilay E, Trawley S, Ward GM, Fourlanos S, Grills CA, Lee MH, MacIsaac RJ, O'Neal DN, O'Regan NA, Sundararajan V, Vogrin S, Colman PG, McAuley SA
Hood KK1, Polonsky WH, MacLeish SA, Levy CJ, Forlenza GP, Criego AB, Buckingham BA, Bode BW, Hansen DW, Sherr JL, Brown SA, DeSalvo DJ, Mehta SN, Lafel LM, Bhargava A, Huyett LM, Vienneau TE, Ly TT
Buskoven MEH, Kjørholt EKH, Strandberg RB, Søfteland E, Haugstvedt A
Masharani U, Strycker LA, Fisher L
Madrid-Valero JJ, Ware J, Allen JM, Boughton CK, Hartnell S, Wilinska ME, Thankamony A, de Beaufort C, Schierloh U, Campbell FM, Sibayan J, Bocchino LE, Kollman C, Hovorka R, Gregory AM, KidsAP Consortium
Assessment of Glucose Monitoring Adherence in Medicare Beneficiaries with Insulin-treated Diabetes
Puckrein GA1, Hirsch IB2, Parkin CG3, Taylor BT4, Norman GJ4, Xu L1, Marrero DG5
1National Minority Quality Forum, Washington, DC; 2University of Washington, Seattle, WA; 3CGParkin Communications, Inc., Henderson, NV; 4Dexcom, Inc., San Diego, CA; 5University of Arizona, Tucson, AZ
The authors studied the potential correlations between race/ethnicity and adherence to prescribed glucose monitoring in a sample of Medicare beneficiaries with diabetes and the way adherence to the method used effected diabetes-related inpatient hospitalizations and correlated costs among beneficiaries with intensive insulin-treated diabetes.
Methods
This 12-month retrospective analysis utilized Centers for Medicare & Medicaid Services data to identify Medicare beneficiaries who used intensive insulin therapy from January through December 2018 and classified them into four groups: (1) persons using real-time continuous glucose monitoring (rtCGM), (2) persons using any method of blood glucose monitoring (BGM) who followed prescribed use patterns (adherent), (3) persons who were prescribed BGM but were nonadherent in its use, and (4) no record of any form of BGM. Analyses compared these groups and the role that comorbidities (Charlson Comorbidity Index [CCI]), and race/ethnicity played on group assignment, diabetes-related inpatient hospitalizations, and costs.
Results
Among the 1,329,061 persons assessed, 38.14% had no record of glucose monitoring and 35.42% were BGM nonadherent. Similarly, among the 629,514 beneficiaries with a CCI risk score of ≥ 2, 466,646 (74.13%) were either nonadherent to BGM or had no monitoring record. The percentage of White (3.65%) rtCGM adherent beneficiaries was significantly larger than Black (1.58%) and Hispanic (1.28%) beneficiaries, both P < 0.0001. Hospitalizations and costs were higher for Black and Hispanic beneficiaries versus Whites within the risk score ≥ 2 group regardless of glucose monitoring method.
Conclusions
Race is correlated with increased hospitalizations and costs associated with diabetes care and lack of any form of BGM was correlated with higher rates of comorbidities. Persons of color were less likely to use rtCGM despite Medicare coverage. To increase the use of glucose monitoring among Medicare diabetic patients, new programs that enhance diabetes self-management education and support services are required.
Comments
Puckrein and colleagues provide yet another study reporting widespread inequalities in access and outcomes across ethnic diversity pertaining to diabetes technologies. Although often mooted as a consequence of the U.S. health system, the reality is that such inequalities exist across many health systems. In the United Kingdom, national diabetes pediatric audit data continue to show widespread inequalities in use of technologies in diabetes management across ethnic diversity, inequalities that have widened every year for the past 7 years. The reality remains that these disparities have real consequences for real people. Furthermore, they have financial consequences that are increasingly unsustainable and unjustifiable. Greater efforts are required to understand the reasons behind such inequalities and strategies urgently needed to address them.
Control-IQ Technology Positively Impacts Patient Reported Outcome Measures and Glycemic Control in Youth with Type 1 Diabetes in a Real-World Setting
Zuijdwijk C1,2,3, Courtney J2, Mitsakakis N2, Hayawi L2, Sutherland S2, Newhook D2, Ahmet A1,2,3, Goldbloom EB1,2,3, Khatchadourian K1,2,3, Lawrence S1,2,3
1Division of Endocrinology and Metabolism, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada; 2CHEO Research Institute, Ottawa, Ontario, Canada; 3University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada
In a real-world setting, the effect of the t:slim X2 insulin CSII with Control-IQ technology was investigated, focusing on the quality of life and glycemic management in adolescents with type 1 diabetes (T1D) and their parents.
Methods
This single-center, prospective study of pediatric patients (6–18 years old) with type 1 diabetes (T1D) used a Tandem t:slim X2 pump and Control-IQ technology as part of routine care. Youths (≥ 8 years) and parents filled in validated patient-reported outcome measures (PROMs) at baseline and the end of the study (16 weeks). Glycemic control measures were recorded at baseline and every 4 weeks until the end of the study.
Results
The study enrolled 59 youths, median age of 13.8 years (IQR, 11.1–15.7) and T1D duration of 6.3 years (IQR, 3.1–8.4). The INSPIRE scores (evaluating expectations [baseline] and impact [post] of Control-IQ technology) were favorable: unchanged at the end of the study for the youths and lower for the parents (P = 0.04). Other PROM scores were improved by the end of the study with mean differences for youth and parents, respectively, as follows: Diabetes Impact and Device Satisfaction (DIDS) Scale Diabetes Impact −1.08 ([95% CI, −1.51 to −0.64], P < 0.001) and −1.41 ([95% CI, −1.96 to −0.87], P < 0.001); DIDS Scale Device Satisfaction + 0.43 ([95% CI, 0.11–0.74], P = 0.01) and + 0.58 ([95% CI, 0.31–0.85], P < 0.001); Hypoglycemia Fear Survey −4.41 ([95% CI, −7.65 to −1.17], P = 0.01) and −7.64 ([95% CI, −11.66 to −3.62], P < 0.001); and WHO-5 Well-Being Index + 5.10 ([95% CI, −1.40 to 11.6], P = 0.12) and + 9.60 ([95% CI, 3.40–15.8], P = 0.003). The mean time in range increased from 52.6% at baseline to 62.6% (P < 0.001) at 4 weeks, sustained to 16 weeks.
Conclusions
Control-IQ technology in a real-world setting significantly diminished the negative effect of diabetes on daily life in youths while simultaneously improving their glycemic control.
Comments
The study by Zuijdwijk and colleagues reflects the trend of transition from automated insulin delivery systems clinical trials to real-world studies. The importance of patient-reported outcome measures (PROMs) in assessing medical devices is increasingly recognized as one way to directly measure the health condition of patients from their own report, without outside interpretation. From a patient perspective, both changes in glycemic control and quality of life are important when considering the use of automated insulin delivery (AID). Recent real-world studies with both adults and children and adolescents with type 1 diabetes (T1D) using AID systems have shown improvement in psychosocial outcomes and persistent achievement of glycemic targets (1 –5). Pediatric clinical studies evaluating the use of AID systems have shown improvement in glycemic control as well as patient-reported outcome measures (e.g., improvements in parental sleep and fear of hypoglycemia).
Attitudes and Behaviors with Diabetes Technology Use in the Hospital: Multicenter Survey Study in the United States
Madhun NZ1, Galindo RJ2, Donato J3, Hwang PR4, Shabir HF4, Fowler MJ5, Molitch-Hou E6, Bena JF7, Umpierrez GE2, Lansang MC1
1Endocrinology and Metabolism Institute, Cleveland Clinic Foundation, Cleveland, OH; 2Division of Endocrinology, Emory University School of Medicine, Atlanta, GA; 3Department of Hospital Medicine, Cleveland Clinic Foundation, Cleveland, OH; 4Division of Hospital Medicine, Emory University School of Medicine, Atlanta, GA; 5Division of Diabetes, Endocrinology, and Metabolism, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; 6Section of Hospital Medicine, Department of Medicine, University of Chicago, Chicago, IL; 7Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH
To evaluate the attitudes, behaviors, and barriers with diabetes technology use in the general medicine hospital wards.
Methods
A nonincentivized, web-based, anonymous survey collected demographic and practice data regarding continuous subcutaneous insulin infusion (CSII) and continuous glucose monitor (CGM) as used in four large hospital systems in the United States
Results
Among 128 survey respondents, 76%, 10%, and 6% were hospitalists, advanced practice providers, and primary care physicians, respectively. The majority of respondents rated the treatment of inpatient hyperglycemia (96%) and the continuation of CSII during the hospital stay (93%) “important.” While most respondents (64%) acknowledged knowing the existence of their institution's policies for CSII use, only 84% of those respondents felt somewhat to very familiar with the policy. The most common barrier to CSII use in the inpatient setting was lack of practitioner (70%) and nursing (67%) knowledge of using the device. With regard to CGM use in the hospital, a minority (28%) of respondents were aware of their institution's CGM policies. Less than half of the providers, 43.8%, stated that, when admitting a patient, they reviewed CGM data to guide insulin dosing.
Conclusions
In this U.S. multicenter survey, most inpatient practitioners valued glycemic control, but many were unaware of their institutional policies, had lacked CSII understanding, and were not reviewing CGM data.
Comments
This age-old challenge of the gulf between awareness and engagement is reflected in the results of this study. It potentially reflects the silos that exist in hospital settings where different departments operate in isolation. There is a clear willingness on the part of health-care practitioners to support the use of diabetes technologies, but there is poor understanding of the policies and the devices themselves. Institutional barriers such as these prevent optimized support and outcomes for patients with diabetes, but they are theoretically easily overcome with greater thought and implementation of appropriate policies. Close collaboration between specialist diabetes centers and inpatient teams could reduce these barriers and promote the delivery of best practices, providing greater work-related satisfaction for health-care practitioners as well as improved health outcomes for patients.
Improved Effectiveness of Immediate Continuous Glucose Monitoring in Hypoglycemia-prone People with Type 1 Diabetes Compared with Hypoglycemia-focused Psychoeducation Following a Previous Structured Education: A Randomized Controlled Trial
Serné EH1, van den Berg IK2, Racca C1, van Raalte DH1, Kramer MHH1, de Wit M2, Snoek FJ2 for the BIDON-Consortium Investigators
1Department of Internal Medicine, Diabetes Center, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands; 2Department of Medical Psychology, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
Stepped-care has been suggested in the management of patients with suboptimal hypoglycemia and impaired awareness of hypoglycemia (IAH), at first with psychoeducational programs based on blood glucose awareness training, progressing to diabetes technology in those with urgent need. The authors tested the clinical effectiveness of stepped-care starting with HypoAware and adding continuous glucose monitoring (CGM) as needed, versus immediate CGM in type 1 diabetes (T1D) patients with suboptimal hypoglycemia despite prior structured education in insulin adjustment.
Methods
In this randomized controlled trial (N = 52; mean age 53 years; 56% females), the stepped-care group attended HypoAware. If a severe hypoglycemic event (SHE) had occurred or IAH was still present after 6 months, CGM was initiated. The control group started immediate CGM. The primary end point was the number of participants with self-reported SHE. The secondary outcomes, evaluated at 6 and 12 months, were glycated hemoglobin (HbA1c), the number of participants with IAH time below range (TBR, < 54 mg/dL), and patient-reported outcomes (PROs).
Results
At 6 months, the number of patients reporting SHE had decreased significantly more in the CGM group: −39% (P < 0.05). HbA1c decreased more in the CGM group (−0.47 percentage points, P < 0.05). IAH was restored in 31% of patients in both groups. TBR (< 54 mg/dL) was lower in the CGM group (−2.4 percentage points, P < 0.05). In the stepped-care group, 93% started CGM/intermittently scanned CGM. At 12 months, the number of patients reporting SHE was still higher in the stepped-care group. No differences were found in PROs.
Conclusions
Immediate start of CGM was found more effective than a hypoglycemia-focused reeducation program in reducing SHE risk and attaining glycemic outcomes in patients with problematic hypoglycemia and IAH despite prior education in insulin dose adjustment.
The AH-HA! Project: Transforming Group Diabetes Self-management Education through the Addition of Flash Glucose Monitoring
Polonsky WH1,2, Fortmann AL3, Soriano EC3, Guzman SJ1, Funnell MM4
1Behavioral Diabetes Institute, San Diego, CA; 2University of California, San Diego, CA; 3Scripps Whittier Diabetes Institute, Scripps Health, La Jolla, CA; 4Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI
Most patients who are referred to diabetes self-management education and support (DSMES) programs do not use this tool. Among those who do attend them, dropout rates are high, with anecdotal reports suggesting that low use and completion rates of these programs are a result of their didactic and impersonal nature. This study introduced a more engaging form of DSMES for adults with type 2 diabetes (T2D): a nondidactic “discovery learning”-based DSMES program centered on real-time flash glucose monitoring (FGM).
Methods
In this single-arm pilot study, 35 adults with T2D of duration 1–5 years (aged 21–75 years, hemoglobin A1c (HbA1c) ≥ 8.0%, and not using insulin) were introduced to FGM and participated in five weekly group sessions. The DSMES content was personalized, emerging from the concerns and questions that arose from participants' FGM discoveries. The primary outcome was glycemic change as assessed by masked FGM at baseline and month 3. The secondary outcomes included psychosocial and behavioral measures.
Results
There was a significant gain in percentage time in range (% TIR) 70–180 mg/dL from baseline (55%) to month 3 (74%), and a parallel drop in percentage time above range (TAR) >180 mg/dL from 44% to 25% (P = 0.01). Overall the participants' well-being rose significantly (P = 0.04), and their diabetes distress showed a nonsignificant drop. Participants reported improvements in healthy eating (P < 0.001) and physical activity, although the latter did not reach statistical significance.
Conclusions
A novel DSMES strategy that combines FGM with a highly engaging and participatory patient-driven “discovery learning” form of education improves patients' care.
Comments
Recent consensus statements and several studies have recommended structured education and psychoeducational programs for the management of both T1D and T2D that may contribute to beneficial glycemic control as well as various PROMs such as lifestyle and to a risk reduction for hypoglycemia in patients with problematic hypoglycemia.
Psychoeducational programs have some important advantages. They can make the experience more personally meaningful for participants, thereby enhancing their perceived value and subsequently enhancing retention; they may ameliorate the hassle of wearing the device, and may deliver cost-savings by limiting the use of more expensive CGM-based systems. On the other hand, they can expose patients to unnecessary risks in terms of hypoglycemia, they may not help achieve glycemic targets, and they have a low accessibility rate.
In these two studies, the tension between psychoeducational programs and diabetes technologies is highlighted. The first study suggests that immediately starting CGM is more effective in reducing self-reported severe hypoglycemia risk than a stepped-care approach in individuals with T1D and problematic hypoglycemia. On the other hand, the novel diabetes self-management education and support program in the second study successfully enhanced the use of real-time flash glucose monitoring.
Diabetes Device Downloading: Benefits and Barriers among Youth with Type 1 Diabetes
Palmer BA1, Soltys K1, Zimmerman MB2, Norris AW1,3, Tsalikian E1, Tansey MJ1,3, Pinnaro CT1,3
1Division of Endocrinology and Diabetes, Stead Family Department of Pediatrics; 2College of Public Health; and 3Fraternal Order of Eagles Diabetes Research Center, University of Iowa, Iowa City, IA
The majority of adolescents with type 1 diabetes (T1D) do not achieve their glycemic targets in spite of their increased use of continuous glucose monitoring (CGM). This study determined the proportion of caregivers who review recent glycemic trends (“retrospective review”) and make insulin adjustments based on the data (“retroactive insulin adjustments”). Fear of hypoglycemia and frequency of severe hypoglycemia episodes were considered as well.
Methods
This cross-sectional survey of caregivers of adolescents with T1D collected demographics, diabetes technology usage data, patterns of glucose data review/insulin dose self-adjustment, and scores from the Hypoglycemia Fear Survey (HFS).
Results
Of the 1003 eligible caregivers approached for this study, 191 (19%) responded and participated. Regularly performing retrospective data reviews was associated with having a younger child (12.2 vs 15.4, P = 0.0001) and with CGM use (92% vs 73%, P = 0.004), but was not associated with a significant improvement in the child's hemoglobin A1c (HbA1c) (7.89 vs 8.04, P = 0.65). The caregivers who were regular retrospective reviewers had significantly higher HFS behavior scores (31.9 vs 27.7, P = 0.0002), which remained significantly higher when adjusted for child's age and CGM use (P = 0.005). Linear regression identified a significant negative association between HbA1c (%) and number of retroactive insulin adjustments (0.24% lower mean HbA1c per additional adjustment made, P = 0.02).
Conclusions
Retrospective glucose data review is correlated with better HbA1c when coupled with data-driven retroactive insulin adjustments. However, obstacles to downloading the data were evident even in this cohort of motivated, predominantly CGM-using T1D families.
Comments
The low response rate to this survey raises interesting questions about paternalism in health care and the way that people choose to use their diabetes devices to support their own self-management. Perhaps a more useful question should be “What benefits do users perceive from device download?” The hassles and burdens of diabetes technologies are often underestimated in routine care visits, where the medical model of health care is dominant. Although the results are presented as statistically significant, they are not particularly clinically significant. As such, it must be asked, What impact has been achieved? For example, do the results reflect a need for greater attention in routine visits to how these devices and diabetes management are integrated into an individual's lived experience? Or do the results reflect a need for greater education on how to review retrospective data to inform basal rate adjustments and bolus doses? Or do they reflect a broader need to better understand the way that people with diabetes interact with their devices to optimize both blood glucose levels and quality of life? A greater exploration of these issues is clearly needed if outcomes are to improve.
Psychological Care for Children and Adolescents with Diabetes and Patient Outcomes: Results from the International Pediatric Registry SWEET
Chobot A1,2, Eckert AJ3,4, Biester T5, Corathers S6, Covinhas A7, de Beaufort C8,9, Imane Z10, Kim J11, Malatynska A2, Moravej H12, Pokhrel S13, Skinner T14,15,16, SWEET Study Group17
1Institute of Medical Sciences, University of Opole, Department of Pediatrics, Poland; 2University Clinical Hospital in Opole, Department of Pediatrics, Poland; 3Institute of Epidemiology and Medical Biometry, ZIBMT, Ulm University, Ulm, Germany; 4German Center for Diabetes Research (DZD), Munich-Neuherberg, Germany; 5AUF DER BULT, Diabetes Center for Children and Adolescents, Hannover, Germany; 6Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Division of Endocrinology, Cincinnati, OH; 7APDP, Diabetes Portugal, Lisbon, Portugal; 8Pediatric Clinic/Centre Hospitalier de Luxembourg, Department of Pediatric Diabetes and Endocrinology, Faculty of Technology, Science and Medicine, University of Luxembourg, Esch Belval, Luxembourg; 9UZ Brussels, Department of Pediatric Endocrinology, Brussels, Belgium; 10Children's Hospital of Rabat, UM5S, Rabat, Morocco; 11Seoul National University Bundang Hospital, Seoul National University College of Medicine, Department of Pediatrics, Seongnam, Republic of Korea; 12Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; 13Siddhartha Children and Women Hospital, Department of Pediatrics, Butwal, Nepal; 14Institute of Psychology, University of Copenhagen, Copenhagen, Denmark; 15Department of Psychology, La Trobe University, Bendigo, VIC, Australia; 16Australian Centre for Behavioural Research in Diabetes, Melbourne, VIC, Australia; 17SWEETe.V. Coordination Center, Diabetes Center for Children and Adolescents Kinder- und Jugendkrankenhaus Auf Der Bult, Hannover, Germany
Because children and youths with type 1 diabetes mellitus (T1D) and their families should have easy access to psychosocial care, this study assessed the availability of psychological care and its correlations with glycemic control in centers from the multinational SWEET (Better Control in Pediatric and Adolescent Diabetes: Working to Create Centers of Reference) registry.
Methods
Centers participating in SWEET (n = 112) were invited to complete a specially designed, structured online survey about their psychology services. Linear/logistic regression models adjusted for several confounders were used to determine the patient's hemoglobin A1c (HbA1c in mmol/mol) and odds ratios for diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) as related to the survey responses.
Results
Of the centers with relevant data in the SWEET database, 76 (68%) responded to the survey, and 89% of the centers provided psychological services as well. The availability of psychological service in SWEET centers was associated with a slightly lower HbA1c in their patients (68 vs 72 mmol/mol, P = 0.004) and significantly lower odds for DKA (OR, 1.8 [95% CI, 1.1–2.9]).
Conclusions
The requirements for children and adolescents with T1D and their families to have easy access to psychosocial therapy means the majority of SWEET registration centers provide some kind of structured psychological counseling. The incidence of DKA between centers highlights the benefit of this psychological care and indicates the importance of including such services in multidisciplinary teams. This study underscores the importance of treatment targets in shaping the outcomes in pediatric diabetes care.
Comments
The effectiveness of psychological interventions for people with diabetes is well established. Most pediatric centers from the SWEET registry offered some form of structured psychological care, consistent with the recommendations of easy access to psychosocial care for children and adolescents with T1D and their families. This study found that patients in care centers with mental health services were more likely to use CGM and continuous subcutaneous insulin infusion (CSII). This study also highlights the impact of the availability of psychological care for children with T1D in clinical practice. Thus, these data can be used to extrapolate the benefits of integrating psychological services into pediatric diabetes care and advocating for coverage of costs to remove the potential financial burden from families.
Lived Experience of Older Adults with Type 1 Diabetes Using Closed-Loop Automated Insulin Delivery in a Randomised Trial
Kubilay E1, Trawley S1,2, Ward GM2,3, Fourlanos S2,4,5, Grills CA2,3, Lee MH2,3, MacIsaac RJ2,3,5, O'Neal DN2,3, O'Regan NA6, Sundararajan V2,7, Vogrin S2, Colman PG2,4, McAuley SA1,2,3
1Department of Psychology, Cairnmillar Institute, Melbourne, Australia; 2Department of Medicine, University of Melbourne, Melbourne, Australia; 3Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia; 4Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Melbourne, Australia; 5Australian Centre for Accelerating Diabetes Innovations, University of Melbourne, Melbourne, Australia; 6Department of Geriatric Medicine, Waterford Integrated Care for Older People, University Hospital Waterford, Waterford, Ireland; 7Department of Public Health, La Trobe University, Melbourne, Australia
This study examines the lived experience of older adults with type 1 diabetes (T1D) using closed-loop automated insulin delivery.
Methods
Adults aged ≥ 60 years with long-duration T1D who were enrolled in a randomized, open-label, two-stage crossover trial comparing first-generation closed-loop therapy (MiniMed 670G) versus sensor-augmented pump therapy were offered additional participation in semistructured interviews about their experiences with the intervention. The interview recordings were transcribed, thematically analyzed, and assessed.
Results
After having used the closed-loop system, 21 older adults also participated in the interviews. Of the interviewees, 20 were functionally independent, without frailty or major cognitive impairment, and 1 was dependent on caregiver assistance, including for diabetes management. The questions included quality of life benefits (such as improved sleep and reduced diabetes-related psychological burden) in the context of experiencing improved glucose levels. The gap between their expectations and the reality of closed-loop therapy was emphasized by some participants. Many also perceived the cost as a barrier to continued closed-loop access after the trial. Usability issues, such as disruptive overnight alarms and sensor inaccuracy, were also identified.
Conclusions
Although the lived experience of older adults using first-generation closed-loop therapy was mostly positive and consistent with the glycemic benefits found in the trial, various issues were also brought to light. Future device development should explore older adults' lived experience using automated insulin delivery beyond trial environments, focusing on the usability requirements.
Comments
As closed-loop technologies advance and become more widely available, the potential for older adults to benefit increases. As Kubilay and colleagues specified, the participants in this study were free from frailty or cognitive decline—both factors that must be considered for widespread use among this age group. The same irritations with the systems that have been raised among other age groups persist: overnight alarms, sensor inaccuracy, and high cost. As the technologies continue to advance, these issues will likely decrease. Other factors to consider with the older age group are living in shared facilities (particularly for those who require caregiver assistance or are in residential or hospital settings) and roles and responsibilities in terms of diabetes management tasks. As seen in a different study in this article, it will be crucial that those responsible are aware of the relevant institutional policies and are competent in diabetes management.
Psychosocial Outcomes with the Omnipod 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers
Hood KK1, Polonsky WH2,3, MacLeish SA4, Levy CJ5, Forlenza GP6, Criego AB7, Buckingham BA8, Bode BW9, Hansen DW10, Sherr JL11, Brown SA12, DeSalvo DJ13, Mehta SN14, Lafel LM14, Bhargava A15, Huyett LM16, Vienneau TE16, Ly TT16
1Department of Pediatrics, Psychiatry & Behavioral Sciences, Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford University, Stanford, CA; 2University of California San Diego, San Diego, CA; 3Behavioral Diabetes Institute, San Diego, CA; 4University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital, Cleveland, OH; 5Icahn School of Medicine at Mount Sinai, New York, NY; 6Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO; 7International Diabetes Center, Health Partners Institute, Minneapolis, MN; 8Department of Pediatrics, Division of Pediatric Endocrinology, Stanford University, Stanford, CA; 9Atlanta Diabetes Associates, Atlanta, GA; 10Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY; 11Department of Pediatrics, Yale School of Medicine, New Haven, CT; 12Division of Endocrinology, Center for Diabetes Technology, University of Virginia, Charlottesville, VA; 13Department of Pediatrics, Baylor College of Medicine, Houston, TX; 14Joslin Diabetes Center, Harvard Medical School, Boston, MA; 15Department of Research, Iowa Diabetes Research, West Des Moines, IA; 16Insulet Corporation, Acton, MA
Because improving psychosocial outcomes is crucial for children and adolescents with type 1 diabetes (T1D) and their caregivers, this study investigated these outcomes during a trial of a tubeless automated insulin delivery (AID) system, the Omnipod 5 Automated Insulin Delivery System.
Methods
This single-arm, multicenter, prospective study enrolled 83 children (6.0–11.9 years) and 42 adolescents (12.0–17.9 years) with T1D to use a tubeless AID system for 3 months. The participants and their caregivers completed age- and role-appropriate validated questionnaires to assess changes in their psychosocial outcomes—diabetes distress (Problem Areas in Diabetes Questionnaire [PAID]), hypoglycemia confidence (Hypoglycemic Confidence Scale [HCS]), well-being (World Health Organization-5 [WHO-5]), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), insulin delivery satisfaction (Insulin Delivery Satisfaction Survey [IDSS]), and system usability (System Usability Scale [SUS])—before and after 3 months of AID system use. Correlations between participant characteristics and glycemic results with psychosocial measures were assessed using linear regression analyses.
Results
For children, adolescents, and/or their caregivers, use of the tubeless AID system prompted improvements in the areas of diabetes-related distress, insulin delivery satisfaction, and system usability (all). Additional benefits of improved general well-being, confidence in managing hypoglycemia, and sleep quality (all) were cited by the caregivers of children. Regression analyses showed that the improvements in psychosocial outcomes were generally independent of the baseline characteristics and changes in glycemic outcomes.
Conclusions
The tubeless AID system was correlated with significant improvements in a number of psychosocial outcomes for children, youth, and their caregivers.
Comments
To support broad adoption and sustained use of these technologies, it is important that AID systems improve diabetes-related quality of life in addition to improving glycemic outcomes. Diabetes distress and management burden not only affect children and adolescents with T1D but also their caregivers, and these factors are associated with reduced quality of life and lower attainment of glycemic targets. In addition to improving glycemic outcomes, it is crucial that AID systems be easy to use without adding inconvenience or burden for families. This study examined the psychosocial outcomes for children, adolescents, and their caregivers of a tubeless AID system. The children and adolescents with T1D, as well as their caregivers, found that using the AID system decreased their diabetes-related distress. The caregivers of children also reported numerous additional benefits—including increased confidence in managing hypoglycemia-related problems, increased well-being, increased insulin delivery satisfaction, and some measures of sleep quality.
Sexual Dysfunction in Women with Type 1 Diabetes in Norway: A Qualitative Study of Women's Experiences
Buskoven MEH1, Kjørholt EKH1, Strandberg RB1, Søfteland E1,3,4, Haugstvedt A2
1Faculty of Medicine, University of Bergen, Bergen, Norway; 2Faculty of Health and Social Sciences, Western Norway University of Applied Sciences, Bergen, Norway; 3Department of Medicine, Haukeland University Hospital, Bergen, Norway; 4Hormone Laboratory, Haukeland University Hospital, Bergen, Norway
This study investigated the experiences of sexual health and sexual challenges in women with type 1 diabetes (T1D).
Methods
This qualitative study design enrolled 15 women (26–57 years) with T1D based on their Female Sexual Function Index score indicating sexual dysfunction for semistructured interviews that were thematically analyzed.
Results
Three themes, each with subthemes, characterized the interviews. (1) Diabetes is present at all times (subthemes: having diabetes is onerous, and diabetes affects the relationship with a partner). (2) Sexual health now presents various challenges (subthemes: physical challenges and reduced sexual desire, and sexual health challenges affecting the relationship with a partner). (3) Diabetes may affect sexual function (subthemes: glucose levels and technical devices may impact sexual function, and health-care providers should address sexual health in diabetes follow-ups).
Conclusions
Women with T1D experience a variety of challenges in relation to their sexual health. Reduced sexual desire, vaginal dryness, and pain during intercourse were the most frequently cited issues. To provide comprehensive health services for people with diabetes, inquiring about sexual health during diabetes follow-ups is crucial.
Comments
There has been a growing research interest in women's health and diabetes, with a recognition that women experience diabetes differently from men due to factors including menstruation, menopause, and pregnancy. The results of this study are not dissimilar to data published in 2019 that reported widespread sexual health issues among women with diabetes (6), issues that had been much neglected in routine diabetes care. Sexual health is important not only for reproductive function but also for psychological and social well-being. Feelings of isolation, loneliness, low self-worth, and ugliness persist, and diabetes technologies may contribute to these sensations by making the disease state more outwardly visible through scarring, adhesive rashes, and intrusive devices. More needs to be done to minimize these negative impacts.
The Ubiquity of Diabetes Distress among Adults with Type 1 Diabetes in an Urban, Academic Practice: A Template for Intervention
Masharani U1, Strycker LA2, Fisher L3
1Department of Medicine, University of California, San Francisco, CA; 2Oregon Research Institute, Eugene, OR; 3Department of Family Medicine, University of California, San Francisco, CA
This study evaluated the patterns of diabetes distress in a technologically advanced urban academic clinical setting to guide staff development and response.
Methods
During their regular clinic visits, adult patients with type 1 diabetes (T1D) completed the Type 1 Diabetes Distress Scale. From their responses, descriptive statistics were produced to document the prevalence of diabetes distress both overall and from seven primary sources of distress: powerlessness, disease management, hypoglycemia, negative social perceptions, eating, physician, and family/friends. The relationships of diabetes distress, demographic characteristics, and disease status were explored in additional analyses.
Results
The prevalence of elevated diabetes distress was 30% overall, with 88% of the sample reporting elevated distress from at least one primary source. More elevated distress both overall and from the primary sources was reported by women. An inverse relationship was found between diabetes duration with total diabetes distress (r = −0.19) and with the powerlessness subscale (r = −0.28). Elevated distress from powerlessness was more frequently reported by individuals with no microvascular and/or macrovascular complications (85%) compared with those who do have complications (61%). Use of technology (continuous glucose monitoring, insulin pumps) was not significantly related to diabetes distress. Diabetes distress was positively correlated with hemoglobin A1c (HbA1c); elevated total distress was reported by about 22% of individuals with HbA1c < 53 mmol/mol (< 7%). About a third of the sample (34%–39%) reported elevated distress from powerlessness, hypoglycemia, negative social perceptions, eating, or family/friends.
Conclusions
To tailor staff training and intervention programs and consequently lessen discomfort among distinct populations of individuals with T1D in various settings, clinic-specific patterns of diabetes distress must be identified.
Comments
Masharani and colleagues found no significant difference in total distress between individuals using injections and those using an insulin pump. This implies that the linkage between use of technology and distress is more complicated than anticipated, and that the use of technology may not necessarily influence diabetes distress. Eating distress, however, was significantly more common among people using pumps compared with those using injections. A possible explanation could be the overawareness of food intake that goes along with CGM use.
Although technology provides many wonderful aids, it may potentially add to its users' distress due to access, cost, maintenance, and other issues. Having a CGM, for example, means that blood glucose levels are only a glance away, which could foster distress through simple availability. Thus, excluding technology users from regular distress assessments may be unwarranted.
Sleep Quality and Quantity in Caregivers of Children with Type 1 Diabetes Using Closed-Loop Insulin Delivery or a Sensor-augmented Pump
Madrid-Valero JJ1, Ware J2,3, Allen JM2, Boughton CK2,4, Hartnell S4, Wilinska ME2,3, Thankamony A3, de Beaufort C5,6, Schierloh U5, Campbell FM7, Sibayan J8, Bocchino LE8, Kollman C8, Hovorka R2,3, Gregory AM9, KidsAP Consortium10
1Department of Health Psychology, Faculty of Health Sciences, University of Alicante, San Vicente del Raspeig, Spain; 2Wellcome-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; 3Department of Paediatrics, University of Cambridge, Cambridge, UK; 4Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK; 5DECCP, Clinique Pédiatrique, Centre Hospitalier de Luxembourg, Luxembourg City, Luxembourg; 6Department of Pediatric Endocrinology, University Hospital Brussels, Brussels, Belgium; 7Department of Pediatric Diabetes, Leeds Children's Hospital, Leeds, UK; 8Jaeb Center for Health Research, Tampa, FL; 9 Department of Psychology, Goldsmiths, University of London, London, UK; 10University of Cambridge, Cambridge, UK
The parents of children with type 1 diabetes (T1D) frequently report short and/or poor-quality sleep. This study compared sleep quality and quantity in caregivers of children using a closed-loop system (CL) or sensor-augmented pump (SAP) therapy.
Methods
Forty parents of 21 very young children (aged 1–7 years) living with T1D (mean age, 4.7 ± 1.7 SD) who were participating in a trial of automated systems were recruited for this additional quality of life study. They were classified as caregiver 1 (main analyses) or 2 (supplementary analyses) based on their contribution toward treatment management. The participants provided data from sleep diaries, accelerometers, and questionnaires. The assessments were performed at a single postrandomization time point after the child had completed either the 16-week CL arm (n = 10) or the 16-week SAP arm (n = 11) of the main study.
Results
Overall, the results revealed a mixed pattern, and the group differences were not statistically significant. The direction of the results in the sleep diary data—and the results from caregiver 1 in particular—showed that parents of the CL group (as compared with the SAP group) had a shorter sleep duration but better sleep quality, fewer awakenings, and less waking after sleep onset. Actiwatch data showed that caregiver 1 of the CL (as compared with the SAP) group had a shorter sleep latency, greater sleep efficiency, and less waking after sleep onset. The results from the Pittsburgh Sleep Quality Index also showed better sleep quality for caregiver 1 of the CL group as compared with the SAP group.
Conclusions
Data from this study suggest that sleep quality and quantity in parents of children using CL differed from those who used SAP. CL treatment may be correlated with better sleep quality in the primary caregiver, but further research is needed to confirm these findings.
Comments
The interaction between T1D and sleep disturbance is complex. Contributing factors to disturbances of sleep include an association between achieved glucose control and sleep architecture, with increased deep sleep being associated with lower HbA1c levels. Caregivers of children with physical disabilities report significantly more sleep disturbance than parents of children without disabilities (57% vs 14%), and fear of hypoglycemia is a dominant driver of sleep disturbance for parents of children with diabetes. Closed-loop technologies have been associated with improved sleep for parents in early clinical trials.
The results of the study by Madrid-Valero and colleagues reflect the broader mixed impact on human factors of diabetes technologies as their usage increases (7–8). The benefits experienced by early adopters are not as strongly reflected among the wider populations of people living with diabetes, and they highlight the need for tailored strategies to ensure that families benefit from a reduced burden of technologies as well as diabetes to achieve improved quality of life.
Footnotes
Author Disclosure Statement
No competing financial interests exist.