Abstract
Introduction
A new technology must be well accepted by the patients in order to help them manage their diabetes. Other aspects are the influence of the device on the patient's family as well as coordination of expectations among the diabetes team, the patient, and their family about the advantages and disadvantages of a device in order to have realistic expectations of what the technology can provide. The present chapter will review papers published in the last year that have studied some of these issues.
The authors of this chapter are coming from two different disciplines and schools of thought (physicians and a psychologist), and therefore have sometimes different points of view as to the explanations and conclusions of some of the studies. Therefore, in some of the comments, we express the views of these two disciplines.
A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years
Mauras N 1, Beck R 2, Xing D 2, Ruedy K 2, Buckingham B 3, Tansey M 4, White NH 5, Weinzimer SA6, Tamborlane W 6, Kollman C, 2Diabetes Research in Children Network (DirecNet) Study Group
1Division of Pediatric Endocrinology, Nemours Children's Clinic, Jacksonville, FL; 2Jaeb Center for Health Research, Tampa, FL; 3Division of Pediatric Endocrinology, Stanford University, Stanford, CA; 4Division of Pediatric Endocrinology, University of Iowa, Iowa City, Iowa; 5Department of Pediatrics, Washington University, St. Louis, MI; and 6Division of Pediatric Endocrinology, Yale University, New Haven, CT
Diabetes Care 2012;
Aims
The purpose of this study was to examine whether the use of continuous glucose monitoring (CGM) among children with type 1 diabetes can improve glycemic control in the same way it helps adults. The authors examined the benefits of CGM among young children ages 4 to 9 years with type 1 diabetes.
Methods
In this trial, 146 children with type 1 diabetes (mean age 7.5±1.7 years, 64% on pumps, median diabetes duration 3.5 years) were assigned randomly to CGM or a control group after a run-in phase to determine if they had the potential to successfully wear a sensor. The primary outcome was the number achieving a 0.5% decrease in HbA1c between baseline and 26 weeks without the occurrence of severe hypoglycemia.
Results
After 26 weeks, 19% of the CGM group and 28 percent of the control group (p=0.17) achieved the primary goal. Mean change in HbA1c was −0.1% in each group (p=0.79). Low rates of severe hypoglycemia events were documented in both groups.
The use of CGM decreased over time, and by 26 weeks, 41% were averaging at least six days of wear/week. No correlation between CGM use and change in HbA1c was found (rs =−0.09, p=0.44). CGM wear was well tolerated. Parents reported high satisfaction from the CGM; however, the use of CGM did not affect parental fear of hypoglycemia.
Conclusions
Although parents of 4- to 9-year-old children reported high satisfaction with CGM, glycemic control did not improve. The authors assume that limited usage of CGM and parental fear of hypoglycemia might explain some of these findings. They conclude that one of the important remaining challenges is to overcome the obstacles that prevent optimal day-to-day management.
Feasibility of prolonged continuous glucose monitoring in toddlers with type 1 diabetes
Tsalikian E1, Fox L2, Weinzimer S3, Buckingham B4, White NH5, Beck R6, Kollman C6, Xing D6, Ruedy K6, Diabetes Research in Children Network (DirecNet) Study Group
1Pediatric Endocrinology and Diabetes, University of Iowa, Iowa City, IA; 2Pediatric Endocrinology, Nemours Children's Clinic, Jacksonville, FL; 3Department of Pediatrics, Yale University, New Haven, CT; 4Pediatric Endocrinology and Diabetes, Stanford University, Stanford, CA; 5Department of Pediatrics, Washington University, St. Louis, MO; and 6Jaeb Center for Health Research, Tampa, FL
Pediatric Diabetes 2012:
Aim
The feasibility of continuous glucose monitoring (CGM) use among toddlers with type 1 diabetes (T1D) was examined.
Methods
A total of 23 children younger than four years with T1D used a FreeStyle Navigator® (n=21) or a Paradigm® (n=2) CGM device. The mean age at the beginning of the study was 3.0±0.8 years, while the mean hemoglobin A1c (HbA1c) was 8.0±0.8%. The children used both CSII (n=10) and MDI (n=13). The use of CGM was examined over six months.
Results
Three children dropped out. Nine of the children who completed the six-month follow-up were using the CGM more than six days per week, two children used the CGM four to six days per week, and nine used the CGM less than 4 days per week. Reports of skin reactions were minimal. Parents reported high satisfaction from CGM on the CGM satisfaction scale questionnaire, however, only a slight difference was measured in mean HbA1c between baseline and 6 months (7.9% and 8.0%, respectively). There were infrequent episodes of hypoglycemia and a high percentage of glucose values were in the hyperglycemic range.
Conclusion
CGM was safely used among more than 40 percent of the children participating in this study on a near-daily basis after six months. There were frequent hyperglycemic excursions and a large variability in glucose readings. The authors' emphasize that the parental satisfaction from CGM was high even though a significant improvement in glycemic control was not documented.
Comment
The mission of achieving and maintaining good glycemic control is challenging, and in very young children, this task is even more complicated since young children may not recognize or treat symptoms of hypoglycemia and may have unexpected eating patterns and extreme variability in insulin sensitivity (2). The ADA has higher glycemic targets and A1c targets for young children compared to adolescents and adults, and the general attitude toward glycemic control among caregivers and parents with young children is to avoid severe hypoglycemic episodes, especially seizures, and loss of consciousness. These studies demonstrate that even when parents and their children use the CGM for six or more days a week, they do not lower any of the indices of glycemic control. The CGM appears to be used for reassurance that hypoglycemia is being avoided but not to reduce hyperglycemia. In adults there are MRI and neurocognitive changes in the white matter associated with hyperglycemia (3). It remains to be demonstrated whether these changes will also apply to younger children and result in new glycemic targets for this age group. Parents in both studies reported that they were highly satisfied with using CGM (according to the CGM satisfaction scale), and CGM use was proven to be safe and feasible. As was seen in the JDRF study, only 40% of the subjects in both studies were using the CGM for six or more days per week after six months.
From a psychological point of view it is important to take into consideration the hassles caused by the CGM (e.g. false alarms, pain and information overload) as well as the benefits. These hassles cause not only technical difficulties but also emotional burden and can create a continuous effect of burnout. It is possible that parents who could integrate the benefits of CGM with the hassles, optimally managed the CGM. According to the acceptance and commitment therapy (ACT), people who can set their own goals according to their values can cope better with difficulties and obstacles in their life. In addition, “Self management behaviors may thus evoke thoughts of the illness and reactions to its dangers, which could itself be distressing if a patient believes that distress, fear, worry, and other negative diabetes-related emotions and cognitions must be stopped, altered, or reduced” (4). Patients that can accept the inconvenience of diabetes management along with the negative thoughts about the illness will cope better and will achieve better glycemic control.
Attitudes toward diabetes affect maintenance of drug-free remission in patients with newly diagnosed type 2 diabetes after short-term continuous subcutaneous insulin infusion treatment
Chen A, Huang Z, Wan X, Deng W, Wu J, Li L, Cai Q, Xiao H, Li Y
Department of Endocrinology and Diabetes Center, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
Diabetes Care 2012;
Aims
Sensitivity to insulin and β-cell function can be improved among newly diagnosed type 2 diabetes patients who receive short-term intensive insulin treatment. This treatment can also cause a long-term remission without the need for diabetic medications. In this study, the authors also had participants take the diabetes care profile (DCP) to assess their attitudes toward their diabetes, and correlate this attitude with their chances of a remission, and assess how their attitude was related to preserving a long term remission.
Methods
Adult patients aged from 25 to 70 years old with newly diagnosed type 2 diabetes were asked to participate in the study. All who consented were treated for a period of 2–3 weeks with continuous subcutaneous insulin infusion (CSII). The patients were also asked to participate in a diabetes self-management program while they were staying in hospital and were asked to complete a DCP questionnaire on attitudes toward diabetes in the beginning of the study and 3, 6, and 12 months after suspension of CSII therapy.
Results
In total, 150 of the 187 subjects using CSII for several weeks achieved close-to-normal glycemic values, and 65 patients achieved a remission of more than one year. Patients in this group had better glycemic control and had significantly greater restoration of acute insulin response after CSII in comparison to patients who relapsed. They also had higher educational achievements and were more care oriented (more positive beliefs, ability, and adherence). The differences between the two groups became greater over time. Two factors were found to independently predict long-term remission: self care adherence (measured by Cox proportional hazards model; hazard ratio 0.184, p<0.001) and the degree of insulin resistance before treatment (measured by homeostasis model assessment; 0.854, p=0.053). On the other hand, an elevated 2-h postprandial plasma glucose after CSII (1.156, p=0.015) was a risk factor for relapse.
Conclusions
The authors suggest that the attitudes of the newly diagnosed with type 2 diabetes influences who will have a long-term drug-free remission following a short course of CSII therapy.
Comment
This is one of a few studies that have assessed the utilization of CSII therapy at the time of diagnosis of type 2 diabetes along with the subjects' attitudes toward diabetes and their self-confidence about their ability to take care of themselves. It seems that having negative attitudes creates a vicious circle in which patients tend to neglect the treatment more easily and hence experience more failures in their diabetes management. One of the major differences between patients with type 2 diabetes and patients with type 1 DM is the age of diagnosis. Most patients with type 2 diabetes are diagnosed during adulthood. For this reason, patients with type 2 diabetes often do not get the intensive educational and psychosocial support that children with type 1 diabetes receive. Thus, patients with negative attitudes toward their diabetes may not have the opportunity to change their beliefs and improve their diabetes management (5). The importance of patients' attitudes toward their diabetes demonstrated in this study should encourage diabetes teams to invest psychosocial as well as educational efforts in patients with type 2 diabetes. From a neurocognitive point of view, it is also possible that the problem-solving patterns and attitudes are also influenced by inherited neurological and genetic traits (i.e., an innate trait related to the degree of methylation in certain brain proteins). Future educational programs should integrate knowledge from different fields of research (i.e., neurocognitive, medical, and psychological).
Blood glucose monitoring and glycemic control in adolescents with type 1 diabetes: meter downloads versus self-report
Guilfoyle SM 1, Crimmins NA2,3, Hood KK 1,3
1Center for Adherence Promotion and Self-Management, Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; 2Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; and 3Division of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Pediatr Diabetes 2011;
Background
While meter downloads are the preferred way to assess the frequency of blood glucose monitoring adherence (BGM), reports provided by both adolescents and their parents might be a reasonable substitution in the absence of the former.
Aims
The authors try to identify different variables that might correlate to reported BGM frequencies in adolescents with type 1 diabetes (such as socio-demographic, psychological, and disease-specific correlates) as well as to explore the predictive usability of BGM frequency on glycemic control.
Methods
The study included 143 adolescents (aged 13–18) with type 1 diabetes, and their parents, who receive diabetes treatment at a tertiary care center. Reports of BGM frequencies were given by adolescents and their parents at study baseline. Meter downloads were provided in a subsample of 90 patients. Depression questionnaires were also completed by the adolescents. After 3 months, HbA1c levels were measured.
Results
The authors, using multivariate general linear modeling, found out that older adolescents and patients with more depressive symptoms were correlated with reports of less frequent BGM. Two stepwise multivariate regression models tested the predictive utility of different measures of BGM frequency (i.e., adolescent-reported BGM, parent-reported BGM, and meter download) on glycemic control. Parents' reports of BGM frequency predicted glycemic control when meter download data was not available (p<0.001). Nonetheless, when clinical and contextual variables were included, the meter download data (for frequency of blood glucose monitoring) was the strongest predictor of glycemic control (p<0.0001).
Conclusions
Meter downloads provide the best data on the frequency of blood glucose monitoring and are strongly correlated with glycemic control when contextual variables are considered. Parents' reports of BGM frequencies can serve as reliable proxies when meter downloads are not available, but they may not be as reliable in youth with depressive symptoms.
Depressive symptoms predict change in glycemic control in adolescents with type 1 diabetes: rates, magnitude, and moderators of change
Hood KK 1,2, Rausch JR1,2, Dolan LM2,3
1Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; 2Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; and 3Division of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Pediatr Diabetes 2011;
Aim
The target of this study was to decide if depressive symptoms in youth with type 1 diabetes predict change in glycemic control over time.
Methods
This study included 145 adolescents (aged 13–18 years) who were assessed at baseline and six months later. The subjects completed a questionnaire of depressive symptoms (children's depression inventory; CDI), and their A1c values and adherence to blood glucose monitoring (BGM) were documented.
Results
A change in A1c values through a period of six months was predicted by three variables: CDI change score (B=0.11; p<0.001); BGM frequency at baseline (B=–0.21; p=0.03); and A1c at baseline (B=–0.23; p=0.002). A three-way interaction among these variables was significant (p<0.01) and demonstrated that adolescents with high adherence to BGM who had an A1c ≤7.5% at baseline were resistant to increasing A1c values, even if their depressive symptoms got worse. However, as adherence to BGM declines, there is a synergistic effect with depressive symptoms to accelerate the increase of A1c level over time.
Conclusions
The authors conclude that depressive symptoms can serve as useful predictors of A1c change by themselves as well as when considered with adherence to BGM. Screening for depressive symptoms is needed as well as prevention and intervention strategies in order to enable adolescents with type 1 diabetes to achieve optimal glycemic control.
Changes in treatment adherence and glycemic control during the transition to adolescence in type 1 diabetes
Rausch JR 1, Hood KK 1, Delamater A2, Pendley JS3, Rohan JM 1,4, Reeves G5, Dolan L6, Drotar D 1,4
1Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; 2Department of Pediatrics, University of Miami, Miami, FL; 3Division of Behavioral Health, Alfred I. DuPont Hospital for Children, Wilmington, DE; 4Department of Psychology, University of Cincinnati, Cincinnati, OH; 5Division of Pediatric Endocrinology, Alfred I. DuPont Hospital for Children, Wilmington, DE; and 6Division of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Diabetes Care 2012;
Aim
This study examined models of unidirectional and bidirectional change between treatment adherence and glycemic control in adolescents with type 1 diabetes.
Methods
A total of 225 adolescents with type 1 diabetes at the beginning of adolescence (aged 9–11 years) were enrolled in this 2-year longitudinal, multisite study to assess the effects of glycemic control as measured by HbA1c and adherence to treatment as measured by blood glucose monitoring frequency (BGMF) in the transition to adolescence.
Results
During the 2-year study, HbA1c values increased from 8.2 to 8.6% (p<0.001) and BGMF decreased from 4.9 to 4.5 checks per day (p<0.02). Changes in HbA1c were predicted by changes in the BGMF slope. An increase in HbA1c was correlated with a decrease in BGMF of 1.26 (p<0.001) after controlling for covariates.
Conclusions
Declining adherence to the diabetes regimen as measured by the BGMF had an even greater effect on glycemic control in early adolescence than the effect of declining BGMF in latter adolescence. BGMF provides a powerful tool for targeting diabetes management changes during the critical early years of transition into adolescence.
Comment
Within the complicated field of adherence to diabetes regimen, adolescents may be one of the most challenging groups (6). Several factors are associated with problems in adherence and poor glycemic control in this age group. The literature consistently indicates that “more youth disease care responsibility is associated with poorer self-care.” The increased autonomy demanded by the adolescent, combined with the decrease in family involvement, may contribute to this situation. In addition, studies have suggested that the level of depressive symptoms in children and adolescents with type 1 diabetes is nearly twice the rate that is seen in the general adolescent population (7). Depressive symptoms correlated with a decrease in adherence to diabetes management (less blood glucose monitoring) when early adolescents already had an elevated A1c >7.5%; however, those with an A1c <7.5% did not show an increase in A1c levels despite the development of depressive symptoms. These articles demonstrate the importance of downloading blood glucose meters and assessing the frequency of daily blood glucose monitoring. A decline in blood glucose monitoring is strongly correlated with increasing A1c levels. One less blood test each day at the beginning of these studies was associated with an A1c increase of 0.21% six months later, and if the children's depressive inventory increased by one point over six months, there was a 0.11% increase in the A1c.
From a psychological perspective, it is worth mentioning the conclusion made by Guilfoyle et al. (2011; discussed previously) that “disease-related tasks, such as BGM and remembering to bring meters to clinic visits, often have lower priority due to increased autonomy and the competing social, emotional, and academic demands of adolescence.”
Adolescents are dealing simultaneously with multiple tasks—developmental, academic, and social. In this equation, diabetes management often gains low priority. Recent studies have shown that adolescents tend to procrastinate and even to ignore their diabetes reliabilities for different reasons (i.e., avoiding hypoglycemia, embarrassment, inconvenience of treatment, competing tasks, and emotional pain) (8,9). Using diabetes technology can help the adolescent with this burden and improve the diabetes management. In addition, the diabetes team should take into consideration that poor glycemic control should not be automatically identified with lack of adherence but should encourage the team and help adolescents with type 1 DM overcome the barriers that stand in their way.
Effectiveness of sensor-augmented pump therapy in children and adolescents with type 1 diabetes in the STAR 3 study
Slover RH1, Welsh JB2, Criego A3, Weinzimer SA4, Willi SM5, Wood MA6, Tamborlane WV4
1Barbara Davis Center for Childhood Diabetes, Aurora, CO; 2Medtronic Inc., Northridge, CA; 3Park Nicollet Clinic, St. Louis Park, MN; 4 Department of Pediatrics, Yale School of Medicine, New Haven, CT; 5Children's Hospital of Philadelphia, Philadelphia, PA; and 6Devos Children's Hospital, Grand Rapids, MI
Pediatr Diabetes 2012;
Aim
This study compared multiple daily injection (MDI) therapy to sensor-augmented pump (SAP) therapy in children and adolescents.
Methods
A total of 82 children (aged 7–12) and 74 adolescents (aged 13–18) with A1C values ranging from 7.4 to 9.5% participated in the sensor-augmented pump therapy for A1C reduction (STAR 3) 1-year trial. The participants were randomized to either SAP or MDI therapy. Quarterly A1C values were obtained from all participants. One week CGM studies were obtained at baseline, 6 months, and 12 months on all subjects. At baseline, all subjects were blinded to CGM results, and MDI subjects were blinded to the 6- and 12-month results. Sensor adherence was recorded in the SAP group.
Results
Subjects with similar A1c values were randomly assigned to the SAP (8.26±0.55%) and MDI groups (8.30±0.53%). All subsequent A1c values showed a significant difference (p<0.05), favoring SAP therapy. Compared to the MDI group, subjects in the SAP group were more likely to achieve their age-appropriate A1c goals and had lower area-under-the-curve (AUC) values for hyperglycemia without an increased risk of hypoglycemia. Glucose variability improved in the SAP group compared to the MDI group. Children ages 7–12 years old were more likely to wear the CGM sensors and reach age-specific A1c goals than the adolescents (13–18 years old).
Conclusions
Both children and adolescents with inadequately controlled type 1 diabetes can benefit from SAP therapy, allowing them to reduce A1c values, hyperglycemic excursions, and glycemic variability in a sustainable and safe way.
Psychosocial correlates of continuous glucose monitoring use in youth and adults with type 1 diabetes and parents of youth
Markowitz JT, Pratt K, Aggarwal J, Volkening LK, Laffel LMB
Joslin Diabetes Center, Boston, MA
Diabetes Technol Ther 2012;
Background
Consistent use of continuous glucose monitoring (CGM) has been shown to improve glycemic control and reduce hypoglycemia. Adolescents, however, are less likely to use CGM consistently. The authors compared psychological characteristics of adolescents with type 1 diabetes, their caregivers, and adults with type 1 diabetes. This was an ancillary study to the JDRF randomized clinical trial.
Methods
Subjects recruited at a single site of the Juvenile Diabetes Research Foundation CGM trial were randomized to CGM or standard blood glucose monitoring (BGM) and completed psychosocial measures at the six-month visit.
Results
Fear of hypoglycemia was reported more among parents in both groups than adolescents in the corresponding groups. Trait anxiety was higher among CGM adolescents than for BGM adolescents, whereas CGM adults reported less state and trait anxiety than BGM adults. CGM parent-proxy report of depression was higher than that reported by BGM parents.
Conclusions
Adolescents, their parents, and adults report different psychological impacts of CGM use. In some groups and with some variables, CGM use was correlated with a positive psychosocial effect, whereas in others, CGM use was correlated with a negative psychosocial effect. The authors call for future studies that will examine the psychological outcomes of CGM use.
Comment
Both studies compared one of the most challenging age groups, adolescents (6), to other age groups (children, adults, and parents). Similar to other studies, the results show that teenagers who achieved less favorable results in most measures, such as adherence to CGM use, have higher HbA1c values. However, it is noteworthy that the adolescent age group is not completely homogenous. In the STAR-3 trial, 46% of the adolescents wore the CGM consistently until the end of the trial. Many adolescents significantly improved their glycemic control in comparison to the MDI group.
Unfortunately, only few studies have examined youth diabetes management from positive psychology point of view. Positive psychology is a contemporary branch in the field of psychology research that emphasizes promoting mental health rather than merely treating mental illness. In other words, instead of focusing on the causes for poor glycemic control—such as anxiety, family conflicts, and lack of motivation and adherence to treatment—research should focus on the patients who cope well and their strengths such as optimism, values, and the effect of these positive attitudes and good relationships with diabetes management. Future studies should examine the variance within the adolescent group to explore not just their weaknesses but also some of their positive qualities, such as coping skills, resilience, self-efficacy, and hope (7).
Patient perceptions of using the OmniPod system compared with conventional insulin pumps in young adults with type 1 diabetes
Lebenthal Y 1, Lazar L1,2, Benzaquen H 1, Shalitin S 1,2, Phillip M 1,2
1The Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; and 2Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
Diabetes Technol Ther 2012;
Aim
This study conducted an evaluation of treatment satisfaction, comfort, and function between two groups: subjects using the wireless OmniPod™ Insulin Management System (Insulet Corp., Bedford, MA) compared with conventional (infusion set) CSII in young adults with type 1 diabetes.
Methods
Twenty-nine subjects (age, 24.0±5.1 years; diabetes duration, 12.1±5.7 years; insulin pump duration, 6.4±3.1 years; glycated hemoglobin [HbA1c], 8.6±0.7%) took part in a randomized, two-arm open crossover study comparing two sequential 12-week terms of continuous subcutaneous insulin infusion (CSII): one term using the OmniPod system and the other period using conventional CSII. The main result measures were treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), user evaluation (OmniPod System User Evaluation Questionnaire), and HbA1c values.
Results
Treatment satisfaction was high at baseline, with a mean score of 28.6±4.6 (maximal score, 36), and there was no significant difference between the two randomized groups. Upon completion of the study, 43% reported that they “would switch to OmniPod,” 36% were “undecided,” and 21% “would not switch pumps.” Also, 76% percent preferred the OmniPod automated canola insertion system, and 56% reported that OmniPod fit better into their lifestyle than conventional CSII. HbA1c levels significantly decreased with both OmniPod and conventional CSII (7.9±0.9% vs. 8.8±0.7% and 8.2±0.9% vs. 8.5±0.5%, respectively; p<0.001 for both groups) after completion of the first treatment arm. An improvement in HbA1c values was more significant in the OmniPod group (p=0.044), without additional improvement at the end of the study in either group.
Conclusions
The OmniPod system was well accepted by young adults with type 1 diabetes experienced with conventional CSII.
Comment
This study is added to a growing list of studies measuring the degree of satisfaction and usability of diabetes technologies from the patient's point of view. This tendency expresses a change in terminology as well as in conceptualization from using the term “compliance,” which represents the obligation of the patient to meet the medical demands, to “adherence,” which emphasizes the collaboration of the patient and the doctor, and toward “concordance,” a client-centered approach that encompasses the idea that the doctor and the patient are equals and that the patient makes informed decisions (10). Patients with knowledge and understanding, and who are involved in making decisions about their therapy, have a better chance to achieve optimal control of their diabetes. In this study, the patients were asked to express their views about the influence of different devices on their lifestyle as well as evaluating technological features of the device management system. Taking patient perceptions into consideration will also help doctors and engineers to develop better devices in the future.
Insulin pump therapy with automated insulin suspension in response to hypoglycemia: reduction in nocturnal hypoglycemia in those at greatest risk
Choudhary P 1, Shin J2, Wang Y2, Evans ML3, Hammond PJ4, Kerr D5, Shaw JAM6, Pickup JC 1, Amiel SA1
1Department of Diabetes, King's College London School of Medicine, London, United Kingdom; 2Medtronic Inc, Northridge, CA; 3Institute of Metabolic Science, Addenbrooke's Hospital, University of Cambridge, Cambridge, United Kingdom; 4Harrogate District Hospital, Harrogate, United Kingdom; 5Bournemouth Diabetes and Endocrine Centre, Bournemouth District General Hospital, Bournemouth; United Kingdom; and 6Institute for Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom
Diabetes Care 2011;
Objective
The aim of this study was the assessment of the low-glucose-suspend (LGS) feature in the sensor-augmented insulin pump. This feature enables the pump to automatically suspend basal insulin transmission when the sensor is detecting hypoglycemia for up to two hours.
Methods
Thirty-one adults with type 1diabetes participated in this study for three weeks using the LGS feature of the Paradigm Veo insulin pump (Medtronic, Inc., Northridge, CA).
Results
In all, 166 episodes of LGS were detected: 66% of daytime LGS episodes were ended within 10 min and 20 episodes lasted the maximum 2 h. The use of LGS was correlated with reduced nocturnal duration ≤2.2 mmol/L in those in patients who were in the top 25% of nocturnal hypoglycemia at baseline (median 46.2 vs. 1.8 min/day, p=0.02 [LGS-OFF vs. LGS-ON]). Median sensor glucose was 3.9 mmol/L after 2-h LGS and 8.2 mmol/L at 2 h after basal restart.
Conclusions
The authors conclude that use of an insulin pump with LGS was correlated with diminished nocturnal hypoglycemia in those patients at high risk for nocturnal hypoglycemia. The device was well received by the patients.
Health-related quality of life and treatment satisfaction in the sensor-augmented pump therapy for A1c reduction 3 (STAR 3) trial
Rubin RR1,2, Peyrot M1,3 for the STAR 3 Study Group
1Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD; 2Department of Pediatrics, The Johns Hopkins University School of Medicine, Baltimore, MD; and 3Department of Sociology, Loyola University Maryland, Baltimore, MD
Diabetes Technol Ther 2012;
Aim
The authors evaluated health-related quality of life (HRQOL) and satisfaction from treatment in sensor-augmented pump therapy (SAPT) compared with conventional therapy—multiple daily injection (MDI) treatment with self-monitoring of blood glucose (SMBG) regimen. Both adults and children with type 1 diabetes and children's caregivers participated in this study. Patient acceptance of new treatment is crucial to their adoption and effective use.
Methods
A total of 485 adult and children subjects participated in STAR 3, a randomized 12-month clinical trial, comparing SAPT with MDI+SMBG. Within- and between-therapy group changes in generic HRQOL, diabetes-specific HRQOL (fear of hypoglycemia), and therapy satisfaction were evaluated (significance criterion p<0.01).
Results
In adults, children, and parents, there were no significant between-arm changes in generic HRQOL: SF-36 physical component summary and mental component summary scores in adults and the PedsQL physical health summary and psychosocial health summary scores in children or parents. Diabetes-specific improvement in the HRQOL (Hypoglycemia Fear Survey worry and behavior subscale scores) was higher in SAPT than in MDI adults. Improvement in the hypoglycemia behavior scores was higher in SAPT parents. Improvement in the main therapy satisfaction measures (insulin delivery system rating questionnaire measures of convenience, efficacy, and overall preference) was higher in SAPT adults, children, and parents (all p<0.001); all surpassed the criterion for minimal detectable difference.
Conclusions
The authors conclude that this is the first-ever large-scale study comparing SAPT with conventional therapy. SAPT had significant benefits for hypoglycemia fear in adults and caregivers and for treatment satisfaction in adults, children, and parents.
Comment
Hypoglycemic episodes are an unpleasant experience for the patient as well as their parents and other family members and are correlated with a risk for physical and cognitive harm, especially among very young children (11 –13). This experience may cause anxiety reactions known in the literature as “fear of hypoglycemia” (FoH) and measured by the Hypoglycemia Fear Survey. This anxiety disorder affects many aspects of adult patients as well as children and their caregivers' lives, both in the behavioral aspect (obsessive self-monitoring, avoidant behavior, sleep deprivation) and in the emotional one (negative thoughts about catastrophic situations, sense of loss of control). Patients who suffer from fear of hypoglycemia may deliberately keep BG levels too high and put themselves at greater risk for future complications.
The Choudhary et al. (2011) article described previously demonstrated that a low-glucose-suspend feature on a sensor-augmented pump can significantly decrease the length of severe overnight hypoglycemia, providing a therapeutic tool for those at the highest risk of hypoglycemia. The Rubin and Peyrot (2012) article demonstrated that using sensor-augmented-pump therapy for a year can result in a significant decrease in the fear of hypoglycemia. A fully automated, reliable system that does not require human intervention (full closed-loop) has the potential to dramatically decrease fear of hypoglycemia. While numerous efforts are invested in building full closed-loop systems, efforts should also focus on implementing low-glucose-suspend and predictive low-glucose-suspend features into sensor-augmented pumps and making these technologies readily available to patients. Neither of these systems cause insulin to be delivered based on the sensor signal, so there is very little risk in implementing these features other than the risk of raising glucose levels (and therefore A1c levels) if there are prolonged or frequent insulin pump suspensions. For patients at a high risk of hypoglycemia (hypoglycemia unawareness) or people who have fear of hypoglycemia, a mild increase in glycemia may be a very acceptable alternative to frequent, recurrent hypoglycemia. This vision should be integrated with the support of a multidisciplinary diabetes team to integrate medical, educational, and psychosocial support.
A continuous glucose monitoring and problem-solving intervention to change physical activity behavior in women with type 2 diabetes: a pilot study
Allen N 1, Whittemore R2, Melkus G3
1Connell School of Nursing, Boston College, Chestnut Hill, MA; 2School of Nursing, Yale University, New Haven, CT; and 3College of Nursing, New York University, New York, NY
Diabetes Technol Ther 2011;
Background
Diabetes technology has the potential to supply helpful data for theory-based behavioral counseling. This study was designed to assess the feasibility, acceptability, and preliminary efficacy of a CGM and problem-solving, advising intervention to change physical activity (PA) behavior in women with type 2 diabetes.
Methods
Twenty-nine women with type 2 diabetes were randomly assigned to one of two treatment arms: continuous glucose monitoring and problem-solving skills or continuous glucose monitoring and general diabetes education. Feasibility data were obtained on intervention dose, implementation, and satisfaction. Preliminary efficacy data were assembled at the beginning of the study and after a period of 12 weeks on the following measures: PA amount and intensity, diet, problem-solving skills, self-efficacy for PA, depression, hemoglobin A1c, weight, and blood pressure. Demographic and utilization variables were described using frequency distributions and summary statistics. Satisfaction data were analyzed using Wilcoxon rank. Changes between groups were analyzed using linear mixed-modeling.
Results
The majority of the women participated in this study were white/non-Latina with a mean age of 53 years, mean 6.5-year history of diabetes, and poor glycemic control. The only statistically significant change was that the group who received problem-solving education had significantly greater problem-solving skills. There was no significant change in dietary adherence, moderate activity minutes, weight loss, or higher intervention satisfaction pre-to post-intervention between the two groups.
Conclusion
A continuous glucose monitoring plus problem-solving intervention proved to be feasible and acceptable. Subjects in this group had better problem-solving skills than continuous glucose monitoring plus education group subjects.
Comment
This was an interesting article in that it looked at using CGM data to help modify behavior in subjects with type 2 diabetes, which is a group of patients with a very small percent of CGM users. This was a small study and there was no significant difference in the major health outcome measures, but the group that received problem-solving education showed a trend to do better than the group who only received diabetes education (which they may have already been familiar with).
Unfortunately, this was a short study (12 weeks), and they did not provide any data on the difference in CGM usage between the two groups. Using the CGM in day-to-day management can be a very challenging and demanding task for the patient. Experience of frustrations with various mechanical features associated with continuous glucose monitoring (alarms, calibrations, glucose discrepancies, and inaccuracies) are not uncommon. Another challenging aspect is the use of the great deal of information presented by the CGM. Patients that lack good problem-solving skills can find themselves confused and are at high risk for discontinuation of the device. It is important to emphasize that screening of problem-solving skills and providing these skills to patients through education and counseling will help the patient utilize the CGM successfully and improve his or her diabetes management and quality of life.
Footnotes
Author Disclosure Statement
A.L. declares that no competing financial interests exist. B.B. has received research support from Medtronic, Minimed, and Dexcom and serves on the advisory boards of BD and Sanofi-Aventis. M.P. is a member of the advisory boards of AstraZeneca, Sanofi, Medtronic, and Eli Lilly. He is a consultant to Bristol-Myers-Squibb, AstraZeneca, and Andromeda. He is on the speaker s bureau of Johnson & Johnson, Sanofi, Medtronic, Novo Nordisk, and Roche. He is a shareholder of CGM-3 and D-Medical.