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  • Effectiveness of diabetes self-management education and support via a smartphone application in insulin-treated patients with type 2 diabetes: results of a randomized controlled trial (TRIGGER study)

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Clinical Care/Education/Nutrition
Original research
Effectiveness of diabetes self-management education and support via a smartphone application in insulin-treated patients with type 2 diabetes: results of a randomized controlled trial (TRIGGER study)
  1. Anne Meike Boels1,
  2. Rimke C Vos1,2,
  3. Lioe-Ting Dijkhorst-Oei3,4,
  4. Guy E H M Rutten1
  1. 1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
  2. 2LUMC-Campus The Hague, Leiden University Medical Center, Hague, The Netherlands
  3. 3Department of Internal Medicine, Meander Medisch Centrum, Amersfoort, Utrecht, The Netherlands
  4. 4Department of Internal Medicine, Amsterdam UMC-Locatie VUMC, Amsterdam, Noord-Holland, The Netherlands
  1. Correspondence to Dr Anne Meike Boels; a.m.boels{at}umcutrecht.nl

Abstract

Objective To investigate the effect of diabetes self-management education and support via a smartphone app in individuals with type 2 diabetes on insulin therapy.

Research design and methods Open two-arm multicenter parallel randomized controlled superiority trial. The intervention group (n=115) received theory and evidence-based self-management education and support via a smartphone app (optionally two or six times per week, once daily at different times). The control group (n=115) received care as usual. Primary outcome: HbA1c at 6 months. Other outcomes included HbA1c ≤53 mmol/mol (≤7%) without any hypoglycemic event, body mass index, glycemic variability, dietary habits and quality of life. We performed multiple imputation and regression models adjusted for baseline value, age, sex, diabetes duration and insulin dose.

Results Sixty-six general practices and five hospital outpatient clinics recruited 230 participants. Baseline HbA1c was comparable between groups (8.1% and 8.3%, respectively). At 6 months, the HbA1c was 63.8 mmol/mol (8.0%) in the intervention vs 66.2 mmol/mol (8.2%) in the control group; adjusted difference −0.93 mmol/mol (−0.08%), 95% CI −4.02 to 2.17 mmol/mol (−0.37% to 0.20%), p=0.557. The odds for achieving an HbA1c level ≤7% without any hypoglycemic event was lower in the intervention group: OR 0.87, 95% CI 0.33 to 2.35. There was no effect on secondary outcomes. No adverse events were reported.

Conclusions This smartphone app providing diabetes self-management education and support had small and clinically not relevant effects. Apps should be more personalized and target individuals who think the app will be useful for them.

Trial registration number NTR5515.

  • insulin
  • type 2 diabetes

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjdrc-2019-000981

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    Footnotes

    • Presented at This trial has been presented as a poster presentation during the EASD Conference in Berlin, October 2018.

    • Contributors GEHMR and RCV designed the study. AMB developed the smartphone app content and participated in the design of the study. AMB coordinated the fieldwork, analyzed the data and drafted the manuscript. LTDO coordinated the fieldwork in one site. GEHMR, RCV and LTDO reviewed and edited the manuscript. All authors read and approved the final manuscript. AMB 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.

    • Funding The study was funded by Sanofi-Aventis.

    • Disclaimer No names of insulin, neither specialties nor generic ones, have been mentioned in any app message or in other information to the patient. Sanofi-Aventis had no role in the design of the study; in the data collection, analysis, and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.

    • Competing interests GEHMR received fees from Novo Nordisk for consultancy and lecturing.

    • Patient consent for publication Not required.

    • Ethics approval The Medical Ethical Committee of the University Medical Center Utrecht approved the study protocol and the trial was prospectively registered in the Dutch trial register.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request.