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)

Boels, Anne Meike; Vos, Rimke C; Dijkhorst-Oei, Lioe-Ting; Rutten, Guy E H M

doi:10.1136/bmjdrc-2019-000981

Cited by 50Mobile Health and mHealth ApplicationsDiabetes Management and EducationDiabetes Management and 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)

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Boels, Anne Meike, Vos, Rimke C, Dijkhorst-Oei, Lioe-Ting, Rutten, Guy E H M·2019·BMJ Open Diabetes Research & Care

DOI 10.1136/bmjdrc-2019-000981PMC PMC6954800

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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.

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Of the 27 papers, 12 focused on T2DM, with 743 patients in the intervention groups and 645 in the control groups.
“12 were focused on T2DM (743 patients in the intervention groups and 645 patients in the control groups) [50-61]”
From Effectiveness of Disease-Specific mHealth Apps in Patients With Diabetes Mellitus: Scoping Review (2021) · cites this paper as [52]
In T2DM, eleven studies reported a decrease of HbA1c within the app intervention groups, yielding a mean difference of -0.42%.
“Eleven of the studies reported a decrease of HbA1c within the app intervention groups, yielding a mean difference of –0.42% [50-52,54-61], but only 1 study reported a significant change of –1.1% (P<.001) [56].”
From Effectiveness of Disease-Specific mHealth Apps in Patients With Diabetes Mellitus: Scoping Review (2021) · cites this paper as [52]
Three T2DM studies did not find a significant difference between groups.
“while 3 studies did not find a significant difference between groups [52,59,60] and 1 study did not report on differences between groups [61].”
From Effectiveness of Disease-Specific mHealth Apps in Patients With Diabetes Mellitus: Scoping Review (2021) · cites this paper as [52]
Two T2DM studies (229 intervention, 224 control) used the SDSCA questionnaire to evaluate self-care.
“Two studies (229 patients in the intervention groups and 224 patients in the control groups) used the SDSCA questionnaire to evaluate self-care [52,54].”
From Effectiveness of Disease-Specific mHealth Apps in Patients With Diabetes Mellitus: Scoping Review (2021) · cites this paper as [52]
No significant differences were reported for the scales for blood sugar testing (P=.509) or smoking (P=.729) in T2DM studies.
“No significant differences were reported for the scales for blood sugar testing (P=.509) [52] or smoking (P=.729) [54], which were each included in one study.”
From Effectiveness of Disease-Specific mHealth Apps in Patients With Diabetes Mellitus: Scoping Review (2021) · cites this paper as [52]

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Effectiveness of diabetes self-management education via a smartphone application in insulin treated type 2 diabetes patients – design of a randomised controlled trial (‘TRIGGER study’)
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Self-citation
Additional file 1: of Effectiveness of diabetes self-management education via a smartphone application in insulin treated type 2 diabetes patients â design of a randomised controlled trial (â TRIGGER studyâ )
Boels, A. M., Rutten, G. E. H. M., Zuithoff, N. P. A., de Wit, G. A., & Vos, R. C. (2018) · Figshare · doi:10.6084/m9.figshare.7238912
Self-citation
328-OR: Evaluation of Mobile Health Technology–Based Diabetes Education System for Self-Management of Patients with Type 2 Diabetes Mellitus
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Authors: Boels, A. M., Vos, R. C., Dijkhorst-Oei, L.-T., & Rutten, G. E. H. M.
Affiliations: University Medical Center Utrecht (NL)
Leiden University Medical Center (NL)
Amsterdam University Medical Centers (NL)
Corresponding author: Boels, Anne Meike
ORCID: Boels, Anne Meike
Vos, Rimke C
Dijkhorst-Oei, Lioe-Ting
Rutten, Guy E H M
Venue: BMJ Open Diabetes Research & Care
Publisher: BMJ
Published: 2019-12
Volume: 7
Issue: 1
Pages: e000981
ISSN: 2052-4897 (ISSN-L)
DOI: 10.1136/bmjdrc-2019-000981
PMC: PMC6954800
OpenAlex: W2998712010
Cited by: 50
References: 33
Citations by year: 2026: 2 · 2025: 16 · 2024: 6 · 2023: 9 · 2022: 7 · 2021: 7 · 2020: 3
FWCI: 5.80
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by-nc
Locations: BMJ Open Diabetes Research & Care (publishedVersion, cc-by-nc)
Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
PubMed Central (publishedVersion, cc-by-nc)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion, other-oa)
Pure Amsterdam UMC (submittedVersion, cc-by)
Data Archiving and Networked Services (DANS) (submittedVersion)
Leiden Repository (Leiden University) (submittedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
Funders: Sanofi
Topics: Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords: diabetes self-management education and support, mobile application, type 2 diabetes, insulin therapy, glycemic control, HbA1c, glycemic variability, hypoglycemia, body mass index, dietary habits, quality of life

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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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