Telemedicine compared with standard care in type 2 diabetes mellitus: A randomized trial in an outpatient clinic

Abstract

Introduction

Good metabolic control is important in type 2 diabetes mellitus to improve quality of life, work ability and life expectancy, and the use of telemedicine has proved efficient as an add-on to the usual treatment. However, few studies in type 2 diabetes patients have directly compared telemedicine with conventional outpatient treatment, and we wanted to evaluate whether telemedicine, compared with standard care, provides equivalent clinical outcomes.

Methods

Forty patients with type 2 diabetes mellitus allocated from October 2011–July 2012 were randomized to either treatment at home by video conferences only or standard outpatient treatment. Primary outcomes were HbA1c and blood glucose levels and secondary outcomes were 24-hour blood pressure, cholesterol levels and albuminuria. The video-telephone was a broadband solution installed and serviced by the Danish Telephone Company (TDC).

Results

The improvements in the two treatments, given as changes in percentage of telemedicine vs standard, showed significant differences in HbA1c (−15 vs −11%), mean blood glucose (−18 vs −13%) and in cholesterol (−7 vs −6%). No differences in LDL (−4 vs −6%), weight (−1 vs 2%), diastolic diurnal blood pressure (−1 vs −7%), and systolic diurnal blood pressure (0 vs −1%) were found. Nine consultations were missed in the standard outpatient group and none in the telemedicine group.

Conclusions

In the direct comparison of home video consultations vs standard outpatient treatment in type 2 diabetes mellitus, telemedicine was a safe and available option with favourable outcomes after six months treatment.

Keywords

Remote consultation Telecare Teleconsulting Telemedicine Telehealth

Background

Chronic illnesses, such as diabetes, asthma, chronic obstructive pulmonary disease (COPD), heart failure and hypertension, represent a significant burden of disease which leads to early death.¹ Chronic disease also imposes huge costs on the health care systems as well as for those affected. Non-pharmacological treatment is mandatory for patients with type 2 diabetes mellitus, which is characterized by central obesity, sedentary lifestyle and overeating.¹ Failure to reach treatment goals occurs despite an extensive national diabetes rehabilitation programme in Denmark.² Outpatient control shows positive effects of rehabilitation by reducing hemoglobin A1c (HbA1c), weight and blood pressure.³ However, some patients never achieve good diabetes regulation and, in others, clinical values deteriorate over time. New approaches are required and need testing to motivate and give feedback to patients during daily life at home. Telemedicine has the potential to reach patients where outpatient departments cannot, through direct feedback adapted to the milieu of the patient and, favourably, in concordance with the spouse.

Good metabolic control is important as patients with type 2 diabetes mellitus have an increased risk of cardiovascular disease, neuropathy and nephropathy,⁴ and the impaired quality of life measured by SF-36 and ‘The Diabetes Symptom Checklist’ and work ability estimated by questionaire and health care utilisation interview^5,6 along with life expectancy being six to eight years shorter. Multi-factorial intervention may delay this due to slow progression in achieving treatment goals and use of recommended drugs for the prevention of diabetic vascular complications. Therefore, the early and meticulous treatment according to current guidelines remains a challenge.^3,5 The largest telemedicine study to date, initiated by the Department of Health in England, Whole System Demonstrator (WSD), randomized 3320 patients with chronic obstructive pulmonary disease, heart failure, and diabetes to telemedicine care.⁶ WSD showed that the telemedicine intervention as an add-on therapy reduced mortality to 4.6% compared to a mortality of 8.3% in controls. Similarly, the number of inpatients and the number of bed-days were reduced by 11% and 14%, respectively. The additional cost was 15% per patient for using telemedicine as add-on therapy. Two issues are important when applying telemedicine solutions: First, telemedicine should preferably replace the standard care and not be added on and, second, the patient's own technical equipment should be used, i.e. personal computer, tablet or smartphone; all of which would reduce the cost substantially. Telemedicine allowing video conference at home is available for 98%–99% of all inhabitants in Denmark. A few randomized trials with this technology are available at present and the aim in our study was to test the implementation of telemedicine in our local setting by replacing the standard treatment.

Our study aimed at testing home treatment of type 2 diabetes mellitus by video consultation versus standard outpatient care in a randomized trial. The hypothesis was that the treatment by telemedicine at home was similar to standard care in terms of mean blood glucose, HbA1c, blood pressure and lipid measurements.

Materials and methods

Recruitment of patients with type 2 diabetes mellitus happened at the first visit to the outpatient clinic of the Endocrinology Department, Kolding Hospital, referred by their general practitioners (GPs) for treatment. The individual goals and the medical treatment planned to fulfil the objectives followed a standard screening set-up consisting of albumin/creatinine excretion rate, glomerular filtration rate (GFR), diurnal blood pressure, electrocardiogram, lipid profile, diabetic foot control, arteriosclerotic symptoms, diet and control of home glucose monitors. The type 2 diabetes mellitus patients received outpatient diabetes education prior to inclusion with information on lifestyle interventions. After the patients received information on the study and signed an approval of participation, randomization was completed and participants were assigned to a consecutive, anonymized patient number. A person outside the Endocrinology Department performed the computer randomization. The trial included 40 type 2 diabetes mellitus patients allocated from October 2011–July 2012 (Table 1) and lasted for six months for all patients.

Table 1.

Clinical data of the 40 included patients.

Group	Standard care	Telemedicine care
Number (no.)	22	18
Age (years)	64.6 (36–80)	60.7 (46–83)
Duration of diabetes (years)	8.4 (0–22)	10.7 (2–21)
HbA1c (%)^a	8.1 (6.1–10.7)	9.0 (7.6–12)
BMI (kg/m²)^b	30.4 (23–43)	32.6 (26–39)
Gender (male/female)	14/8	13/5
Insulin treatment (no.)	7	8

BMI: body mass index; HbA1c: Hemoglobin A1c.

Values given as median (range). Standard vs telemedicine group: ^ap < 0.01, ^bp < 0.05.

Sample size and power calculation

The power calculation was based on the results of Vadstrup et al.³ assuming non-inferiority. From HbA1c and mean glucose values of 7.9 ± 0.8% and 9.1 ± 2.3 mmol/l, respectively, we calculated that a difference of 0.3% and 0.8 mmol/l with α = 0.05 and a power of 80 needed just nine (if HbA1c was chosen as measurement) and 11 (if mean glucose was chosen) patients in both randomization arms. Thus, we aimed to include 20 in each group and 40 patients in total.

Analysis plan

The target range of recommendations for glycemia, blood pressure and lipid control for the participants were: HbA1c (48–58 mmol/mol), fasting blood glucose (6.5–7.5 mmol/l), diurnal blood pressure <130/80 mm Hg, low-density-lipoprotein-cholesterol (LDL-cholesterol) <100 mg/dl (<2.5 mmol/l) and start of angiotensin- converting-enzyme inhibitor (ACE)/angiotensin-receptor-blocker (ARB) with elevated urinary albumin/creatinine excretion ≥30 (µg/g). The treatment algorithm was lifestyle adjustment plus metformin and in combination with one or more of the following drugs: insulin, sulfonylurea, Dipeptidyl-peptidase-inhibitor (DPPI), and Glucagon-like-peptide-1 (GLP-1) analogues, according to the Danish treatment algorithm of type 2 diabetes mellitus. The doctor could choose any of the medications and factors taken into considerations were age, renal function, heart failure, obesity, work, economic situation and compliance. Sufficient information of the participants so that they could take part in the choice of treatment as a direct involvement was obtained. After treatment, the patients were encouraged to continue glycaemic control with their GP.

Videophone and blood pressure monitor

The Danish Telephone Company (TDC) delivered, installed and serviced a videophone, model TandBerg E20, through a broadband connection. Blood pressure monitors (Space Lab Inc. 90207) measured diurnal blood pressure.

Inclusion and exclusion criteria

Inclusion criteria were that the participants had to live at home, were able to communicate by video telephone, had no psychiatric disorders, their age was 40–85 years, and were able to administer medication themselves. Exclusion criteria were type 1 diabetes mellitus, speech disabilities, non-Danish speakers or severe chronic disease like renal failure (GFR<30 ml/min), liver insufficiency or current cancer treatment.

Programme structure

In the Danish health system, GPs manage patients with type 2 diabetes mellitus without complications, while treatment of poor metabolic control or complications continues at the regional hospital, like Kolding Hospital. After initial stabilization, which usually lasted three weeks, the patients returned to the GP. Video consultations were the only means of communication in the telemedicine group, and no scheduled video consultations were missed. TDC collected the videophone after three weeks. The patients in the control group attended the outpatient clinic with regular scheduled visits from four to seven weeks.

The two nurses in the telemedicine group and three in the standard care group did most consultations. In both randomization arms, the doctor (O.W.R.) was sometimes present or asked for advice during consultations.

Statistical considerations

The primary outcome variables were changes of HbA1c and mean glucose while diurnal blood pressure, lipids and body weight were secondary outcomes. The intention-to-treat principle was applied in the study and all data are given as mean ± standard deviation (SD) if not stated otherwise. Differences among variables calculated by the Student’s t-test or Mann-Whitney U-test on the non-parametric data. Repeated measurements tested with two-way analysis of variance (ANOVA), with randomization group as group variable and adjusted for body mass index (BMI), smoking, age, duration of diabetes, gender and insulin treatment by adding the variables as covariates. IBM SPSS Statistics 20 was used as the statistical software, with a p-value of less than 0.05 considered as significant.

The Regional Scientific Ethical Committees for Southern Denmark (S-20110044) approved the study. The ClinicalTrials.Gov ID is NCT02214017.

Results

All 40 included patients completed the study and no significant difference was seen in the clinical variables at inclusion (Table 1). The telemedicine group had an average of 4.1 consultations and none were missed. The standard care group had 3.8 visits at an average and 13% of visits were missed. The video telephone was implemented within 48 h after the randomization and the first consultation in the standard care group took place 0–3 days after inclusion. The treatment algorithm proved effective as the patients achieved the individually planned goals irrespective of telemedicine or standard treatment.

In the telemedicine group, an average consultation lasted 18 min compared with 23 min in the standard care group. In the standard group it took extra 3–5 min to get the patient from the waiting lounge and to help them into the consultation room and back. With video communication used for communication, telemedicine is intuitively the fastest method.

At the end of the study the medical treatment was similar in the two treatment groups (control vs. telemedcine group): Metformin (n=16 vs. n=18), sulphonylurea (5 vs 1), DDPI (3 vs 1), GLP-1 analogue (4 vs 7), and insulin (7 vs 8).

HbA1c, mean blood glucose and cholesterol were significantly lower at the end of the study in the telemedicine group compared with standard care (Table 2, Figure 1). Similar values in blood pressure, albuminuria or body weight appeared. All patients in both groups reached the individually set goals.

Table 2.

Results (mean values) at entry and end of the study in telemedicine or standard care group.

	Telemedicine	Percentage change	Standard care	Percentage change	p-Value
Weight (kg)^a	99.7–99.1	0.6	88.0–86.7	1.7	0.023
HbA1c (mmol/mol)	76–61	14.6	65–55	10.6	0.016
Mean glucose mmol/l)	11.7–9.7	17.6	10.3–8.7	13.1	0.015
Cholesterol (mmol/l)	3.8–3.4	7.1	4.3–3.9	6.1	0.044
LDL (mmol/l)	2.1–1.9	4.5	2.3–2.0	5.5	0.33
Systolic BP (mm Hg)	137–137	0	143–139	0.7	0.40
Diastolic BP (mm Hg)	79–78	1.2	79–73	7	0.43

BP: blood pressure; HbA1c: Hemoglobin A1C; LDL: Low-density-lipoprotein-cholesterol.

One patient’s weight of 231 kg was excluded; p-values calculated with two-way analysis of variance, telemedicine vs standard care.

Figure 1.

Changes in variables in the telemedicine (black column) and standard care (white column) groups.

Discussion

We found telemedicine was equivalent to, or in some aspects better than, standard care in type 2 diabetes mellitus patients. The primary goal was a head-to-head comparison of home treatment with video consultations with standard outpatient care and, at the same time, achieving the individually planned goals irrespective treatment modality.

The high incidence of serious co-morbidity in our study groups strengthens the importance of achieving good metabolic control through lifestyle changes and treatment in type 2 diabetes mellitus. Health education shows reduction in cardiovascular risk factors, however, the effect often disappears after the end of the intervention.^7–9 Good self-care and compliance may improve the outcome and reduce diabetes complications¹⁰ and new tools to achieve higher attendance to the national diabetes program needed. Telemedicine represents a popular tool of educating and monitoring care of chronic diseases. Shea et al. showed that HbA1c was reduced for five years in a telemedicine trial designed to test video-conferencing, clinical data entry and review, web-based education materials and monitored chat groups.¹¹ Home telemonitoring compared with telephone calls reduced the HbA1c levels in type 2 diabetes mellitus.¹² The technology gave a statistically significant reduction in HbA1c of ∼0.5% when applied as add-on to standard treatment. It was used adjunctively to a broader telemedicine initiative for adults with type 2 diabetes mellitus.

The results in our primary and secondary end-points confirm that both arms in the trial are effective in reaching the goals. The minor difference in consultations in the two arms seems not to affect the results. Other factors than clinical outcome also favour the telemedicine solution compared with standard care. These are the reduction in patient’s transportation costs, especially in disabled people, the time spent per consultation, and balancing the difference between professionals and patients in communication. The data clearly demonstrate that treatment by home video consultation is a safe procedure with similar outcome in a heterogeneous group of patients with type 2 diabetes mellitus. Telemedicine may fill some of the gaps when quick support is needed, facing the patients with intervals of a few days in home settings, and providing an overview of the patient’s habits, foods and medicine compliance. At least, it improves empowerment by feedback on the daily glucose data more quickly than standard care.

The past five years of technical advancement in hospital and homes has favoured experiments with implementation of telemedicine in Denmark to an extent that it is now a part of the government’s plans. In our setting, the data confirmed previous findings by others and following a meeting with the Ministry of Health and the directors of Kolding Hospital, consultations using specific Skype video communication platform were implemented.

Some of the barriers to implementing video consultations come from doctors and staff, who do not feel they can perform professionally by video and judge the non-verbal language of the patient, fearing the treatment may become diluted and prolonged. We observed the opposite effect since there was a rapid decrease in blood glucose and after three weeks the patient re-established control with their GP. Another consideration is that elderly people perceive handling the modern technology as a barrier; however, in Denmark 84% of the population has access to the Internet, and in our moderately sized study, no technical problems were encountered.

The improvement in glycaemic control achieved by telemedicine was similar to that of randomized controlled trials assessing other case management interventions.^13,14 In studies, where participants had a HbA1c less than 8%, a decrease of 0.2% in HbA1c was found; in studies where participants had baseline HbA1c>8.0% even larger decreases were seen by applying telemedicine.¹⁵

Most diabetes-related mortality is due to macrovascular complications; in particular, coronary, peripheral and cerebral arterial disease.¹⁵ Treatment of hypertension and dyslipidaemia decrease the risk of these complications in a cost-effective manner. The role of tight glycaemic control is less clear as it lowers the risk of microvascular complications but may increase mortality risk in certain populations.^16–20 The Steno-2 trial showed a reduction in mortality and progression to end-stage renal disease through a multifactorial intervention similar to ours.⁵ In the IDEATel study, the clinical improvements were present throughout the five years the study lasted but disappeared after two years in the control arm.^11,12

Limitations of our study are the short observation period and relatively low number of participants, and this calls for a larger randomized study in this field. The strengths of the study are its low cost and accessibility for low-income families and over long distances, ensuring its implementation in rural areas.

In a review, only a few of 1300 telemedicine studies investigated describe clinically important effects, instead most studies focus on technical implementation. Few randomized studies^13,14 have been carried out so far, and more are needed. Furthermore, the studies seldom follow recognized standards and are difficult to compare and evaluate.²¹ In the present study, we applied the same national treatment algorithm in both treatment arms with the same staff and specialist planning of all medical treatment according to individual goals before randomization.

In a review from 2013, Wotton identifies 141 randomized trials with telemedicine solutions of various kinds with a positive effect in 109.²¹ For five particular chronic diseases, Wotton only identified 22 systematic reviews on the use of telemedicine.²¹ In approximately half of these reviews, the authors provide a qualitative summary of the value of telemedicine, usually in the form of a narrative review; none of these conclude negatively, i.e. that telemedicine is not helpful in chronic disease management. Rapid technical development is an important factor for success with use of consultations with tablets, smartphones and personal computers. Most patients may already possess devices for potential use. In 2008, however, the Policy Research Programme in the Department of Health, England, funded a study of high quality, the Whole Systems Demonstrator (WSD) study.^22,23 This large study on telemedicine demonstrates positive effects on clinical outcomes but finds no effect on health-related quality of life; however, the cost was deemed too high. We have no supplemental observations on communication, attitude or other psychological issues in our study. Barriers in adopting the technique do exist which may lead to non-participation and withdrawal from trials. These barriers are about technical competence and operation of equipment, threats to identity, independence and self-care together with various expectations and experiences of disruption to services.^22,23 These findings, regarding perceptions of potential disruption of services and interventions to identity, go beyond expectations that are concerned about privacy and dislike of technology. These insights have implications for health and social care staff, indicating that detailed information and time for discussion is valuable, especially in the introduction of new techniques. It seems especially important for potential recipients to have the opportunity to discuss their expectations. Such views might usefully feed back into design and implementation.

Conclusion

In the present study, all type 2 diabetes mellitus patients in the telemedicine and standard outpatient group had high compliance and both groups obtained the planned goals of HbA1c, blood pressure, lipids and albuminuria. Furthermore, patients experienced advantages in clinical outcomes, reduction in time and travel expenses in the telemedicine group. Telemedicine, provided as video consultations at home, offers an easy and effective method in the treatment of type 2 diabetes mellitus with equivalent or better outcomes in blood glucose, diurnal blood pressure and cholesterol after six months of treatment compared with standard outpatient treatment.

Footnotes

Acknowledgments

The authors thank all of the volunteers for participating in the study and for their willingness to participate in this new form of diabetes treatment. The authors thank Kolding Hospital, Sygehus Lillebælt, Denmark, for allowing access to all of the patients referred with type 2 diabetes in the study period, and providing facilities to perform the consultations. The author contributions were: OW Rasmussen researched data, planned the study, carried out all the consultation, wrote the manuscript; M Loekke participated in the daily consultations, collected blood samples and reviewed the manuscript; FF Lauszus researched data, performed statistics and result section, and contributed to discussion of the manuscript. OW Rasmussen is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Declaration of Conflicting Interest

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study received a grant from the Danish National Health Department of 2.5 million Danish Kroners, ID 211481/14. No other funding was given.

References

Nathan

Buse

Davidson

. Medical management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: A consensus statement of the American Diabetes Association and European Association for the study of diabetes. Diabetes Care 2009; 32: 193–203.

Drivsholm

Snorgard

. Organization of treatment and control of type 2 diabetic patients. [In Danish.] Ugeskr Laeger 2012; 174: 2157–2162.

Vadstrup

Frolich

Perrild

. Effect of a group-based rehabilitation programme on glycaemic control and cardiovascular risk factors in type 2 diabetes patients: The Copenhagen Type 2 Diabetes Rehabilitation Project. Patient Educ Couns 2011; 84: 185–190.

Lotufo

Gaziano

Chae

. Diabetes and all-cause and coronary heart disease mortality among US male physicians. Arch Intern Med 2001; 161: 242–247.

Gaede

Lund-Andersen

Parving

. Effect of multifactorial intervention on mortality in type 2 diabetes. N Engl J Med 2008; 358: 580–591.

Bower

Cartwright

Hirani

. A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: Protocol for the whole systems demonstrator cluster randomized trial. BMC Health Serv Res 2011; 11: 184–184.

Goudswaard

Stolk

Zuithoff

. Long-term effects of self-management education for patients with Type 2 diabetes taking maximal oral hypoglycemic therapy: A randomized trial in primary care. Diabetes Med 2004; 21: 201–207.

Mitra

Dewanjee

Dey

. Mechanistic studies of lifestyle interventions in type 2 diabetes. World J Diabetes 2012; 3: 201–207.

Norris

Lau

Smith

. Self-management education for adults with type 2 diabetes: A meta analysis of the effect on glycemic control. Diabetes Care 2002; 25: 1159–1171.

10.

Rumsfeld

Masoudi

. Effect of medication non adherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med 2006; 166: 1836–1841.

11.

Shea

Weinstock

Tersi

. IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethically diverse, medically underserved patients with diabetes mellitus: 5 Year results of the IDEATel study. J Am Med Inform Assoc 2009; 16: 446–456.

12.

Stone

Rao

Sevick

. Active care management supported by home telemonitoring in veterans with type 2 diabetes: The DiaTel randomized control study. Diabetes Care 2010; 91: 478–484.

13.

Hailey

Roine

Ohinmaa

. Systematic review of evidence for the benefits of telemedicine. J Telemed Telecare 2002; 8: S1–S30.

14.

Durrani

Khoja

. A systematic review of the use of telehealth in Asian countries. J Telemed Telecare 2009; 15: 175–181.

15.

Saaddine

Cadwell

Gregg

. Improvements in diabetes processes of care and intermediate outcomes: United States, 1988–2002. Ann Intern Med 2006; 144: 465–474.

16.

Shojania

Ranji

McDonald

. Effects of quality improvement strategies for type 2 diabetes on glycemic control: A meta-regression analysis. J Am Med Assoc 2006; 296: 427–440.

17.

UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. Br Med J 1998; 317: 703–713.

18.

Patel

MacMahon

Chalmers

. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008; 358: 2560–2572.

19.

Gerstein

Miller

Byington

. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008; 358: 2545–2559.

20.

Barlow J. Building an evidence base for successful telecare implementation–updated report of the Evidence Working Group of the Telecare Policy Collaborative chaired by James Barlow, http://www.ssiacymru.org.uk/home.php?page_id=2281 (2015, accessed 24 September 2015).

21.

Wootton

. Twenty years of telemedicine in chronic disease management–an evidence synthesis. J Telemed Telecare 2012; 18: 211–220.

22.

Cartwright

Hirani

Rixon

. Whole Systems Demonstrator Evaluation Team. Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator Telehealth Questionnaire Study): Nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial. Br Med J 2013; 346: f653–f653.

23.

Sanders

Rogers

Bowen

. Exploring barriers to participation and adoption of telehealth and telecare within the Whole System Demonstrator trial: A qualitative study. BMC Health Serv Res 2012; 12: 220–220.