Effectiveness of video consultations in type 1 diabetes patients treated with insulin pumps in the outpatient clinic: protocol for a randomised controlled trial

Anders Nikolai Ørsted Schultz, Robin Christensen, Georg Bollig, Kristian Kidholm, F Brandt, Anders Nikolai Ørsted Schultz, Robin Christensen, Georg Bollig, Kristian Kidholm, F Brandt

Abstract

Introduction: The purpose of the study is to assess the effectiveness of video consultations in patients with type 1 diabetes mellitus (DM) treated with insulin pumps in the outpatient clinic.

Methods and analysis: A 52 weeks' duration, open-label, randomised controlled trial will be conducted, enrolling 100 patients with type 1 DM currently treated with insulin pump.Patients will be recruited from the diabetes outpatient clinic at Hospital of Southern Jutland, Department of internal medicine, Sønderborg. Participants will be randomised to either video consultations (experimental intervention) or standard care (control comparator). Participants in the video consultation group will follow their standard care treatment but will have all of their scheduled and non-scheduled appointments by video consultation. The control group will follow their standard care treatment as usual, having all their appointments at the outpatient centre. Primary outcome will be change from baseline of time in range (3.9-10.0 mmol/L).

Ethics and dissemination: The study has been approved by the Regional Committe on Health Research Ethics for Southern Denmark, S-20200039G Acadre 20/12922. We will present the results of the trial at international conferences as well as publish the results of the trial in (a) peer-reviewed scientific journal(s).

Trial registration number: NCT04612933.

Keywords: DIABETES & ENDOCRINOLOGY; Protocols & guidelines; Telemedicine.

Conflict of interest statement

Competing interests: ANØS reports personal fees from OpenTeleHealth aps and a grant from Knud and Edith Eriksens Mindefond, outside the submitted work.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Trial plan.

References

    1. Organization WH . Global report on diabetes, 2016. Available:
    1. Diabetes IFo . IDF diabetes atlas IFD. Available:
    1. Stats IW. Available:
    1. Stats IW . Internet users in DK. Available:
    1. Wikipedia . iPhone (1st generation), 2019. Available:
    1. Statista . Number of smartphones sold to end users worldwide from 2007 to 2018 (in million units) Statista, 2019. Available:
    1. Udsen FW, Hangaard S, Bender C, et al. . The effectiveness of telemedicine solutions in type 1 diabetes management: a systematic review and meta-analysis. J Diabetes Sci Technol 2022;19322968221076874.
    1. Danne T, Limbert C, Puig Domingo M, et al. . Telemonitoring, telemedicine and time in range during the pandemic: paradigm change for diabetes risk management in the Post-COVID future. Diabetes Ther 2021;12:2289–310. 10.1007/s13300-021-01114-x
    1. Yaron M, Sher B, Sorek D, et al. . A randomized controlled trial comparing a telemedicine therapeutic intervention with routine care in adults with type 1 diabetes mellitus treated by insulin pumps. Acta Diabetol 2019;56:667–73. 10.1007/s00592-019-01300-1
    1. González-Molero I, Domínguez-López M, Guerrero M, et al. . Use of telemedicine in subjects with type 1 diabetes equipped with an insulin pump and real-time continuous glucose monitoring. J Telemed Telecare 2012;18:328–32. 10.1258/jtt.2012.120103
    1. Sood A, Watts SA, Johnson JK, et al. . Telemedicine consultation for patients with diabetes mellitus: a cluster randomised controlled trial. J Telemed Telecare 2018;24:385–91. 10.1177/1357633X17704346
    1. Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, et al. . The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–86. 10.1056/NEJM199309303291401
    1. Papatheodorou K, Papanas N, Banach M, et al. . Complications of diabetes 2016. J Diabetes Res 2016;2016:1–3. 10.1155/2016/6989453
    1. Wang P, Lau J, Chalmers TC. Meta-Analysis of effects of intensive blood-glucose control on late complications of type I diabetes*1. The Lancet 1993;341:1306–9. 10.1016/0140-6736(93)90816-Y
    1. Battelino T, Danne T, Bergenstal RM, et al. . Clinical targets for continuous glucose monitoring data interpretation: recommendations from the International consensus on time in range. Diabetes Care 2019;42:1593–603. 10.2337/dci19-0028
    1. Danne T, Nimri R, Battelino T, et al. . International consensus on use of continuous glucose monitoring. Diabetes Care 2017;40:1631–40. 10.2337/dc17-1600
    1. Beck RW, Bergenstal RM, Riddlesworth TD, et al. . Validation of time in range as an outcome measure for diabetes clinical trials. Diabetes Care 2019;42:400–5. 10.2337/dc18-1444
    1. Lu J, Ma X, Zhou J, et al. . Association of time in range, as assessed by continuous glucose monitoring, with diabetic retinopathy in type 2 diabetes. Diabetes Care 2018;41:2370–6. 10.2337/dc18-1131
    1. (DES) DES . Insulinpumpebehandlingen I Danmark, 2003. Available:
    1. Bland JM, Altman DG. Statistics notes: bootstrap resampling methods. BMJ 2015;350:h2622. 10.1136/bmj.h2622
    1. Cook JA, Julious SA, Sones W, et al. . DELTA(2) guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. BMJ 2018;363:k3750.
    1. Aleppo G. Clinical application of time in range and other metrics. Diabetes Spectr 2021;34:109–18. 10.2337/ds20-0093
    1. Ruiz de Adana MS, Alhambra-Expósito MR, Muñoz-Garach A, et al. . Randomized study to evaluate the impact of telemedicine care in patients with type 1 diabetes with multiple doses of insulin and suboptimal HbA1c in Andalusia (Spain): PLATEDIAN study. Diabetes Care 2020;43:337–42. 10.2337/dc19-0739
    1. Cao J, Zhang S. Multiple comparison procedures. JAMA 2014;312:543–4. 10.1001/jama.2014.9440
    1. Yadav K, Lewis RJ. Gatekeeping strategies for avoiding false-positive results in clinical trials with many comparisons. JAMA 2017;318:1385–6. 10.1001/jama.2017.13276
    1. Detry MA, Lewis RJ. The intention-to-treat principle: how to assess the true effect of choosing a medical treatment. JAMA 2014;312:85–6. 10.1001/jama.2014.7523
    1. Vickers AJ, Altman DG. Statistics notes: analysing controlled trials with baseline and follow up measurements. BMJ 2001;323:1123–4. 10.1136/bmj.323.7321.1123
    1. White IR, Horton NJ, Carpenter J, et al. . Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ 2011;342:d40. 10.1136/bmj.d40
    1. Sterne JAC, White IR, Carlin JB, et al. . Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ 2009;338:b2393. 10.1136/bmj.b2393
    1. Greenhalgh T, Shaw S, Wherton J, et al. . Real-World implementation of video outpatient consultations at macro, meso, and micro levels: Mixed-Method study. J Med Internet Res 2018;20:e150. 10.2196/jmir.9897
    1. Greenhalgh T, Wherton J, Papoutsi C, et al. . Beyond adoption: a new framework for theorizing and evaluating Nonadoption, abandonment, and challenges to the scale-up, spread, and sustainability of health and care technologies. J Med Internet Res 2017;19:e367. 10.2196/jmir.8775

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