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Open Access 01-12-2022 | Care | Study protocol

Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial

Authors: D. Ehrmann, V. Eichinger, I. Vesper, J. Kober, M. Kraus, V. Schäfer, N. Hermanns, B. Kulzer, S. Silbermann

Published in: Trials | Issue 1/2022

Abstract

Background

Diabetes self-management is a mainstay of diabetes care, but the implementation of self-management regimens into daily life is complex and often results in discouragement and distress. Modern approaches such as smartphone-based self-management applications are therefore needed to support people with diabetes. Since reimbursability would increase the availability of such digital applications to people with diabetes, we designed a study that meets all scientific and methodological requirements set by the German Digital Healthcare Act to allow reimbursement for a specific application (mySugr PRO). Here, we report the protocol of this study that aims at evaluating the efficacy of the digital self-management application with regard to patient-reported outcomes and medical benefits.

Methods/design

This multicenter, open-label, randomized, parallel-group, controlled trial will evaluate the health care effects and medical benefits of mySugr PRO. A total of 466 people with diabetes will be randomly allocated (2:1 randomization) to the interventional group (n = 311) that will use the digital self-management application during the 12-week study period or the control group (n = 155; no usage of the application). Baseline and follow-up examinations will assess diabetes distress as the primary endpoint as well as empowerment, HbA1c, blood glucose data, self-management, general well-being, and treatment satisfaction as secondary endpoints. Statistical analyses will use an intention-to-treat procedure (using multiple imputation for missing values) as well as a per-protocol approach for sensitivity analysis.

Discussion

To the best of our knowledge, this study will be one of the largest diabetes-specific evaluations of a digital health application supporting people with diabetes in their diabetes self-management that follow the requirements of the German Digital Healthcare Act.

Trial registration

German Clinical Trial Register DRKS00022923. Registered on 22 October 2020.

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Title: Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial
Authors: D. Ehrmann
V. Eichinger
I. Vesper
J. Kober
M. Kraus
V. Schäfer
N. Hermanns
B. Kulzer
S. Silbermann
Publication date: 01-12-2022
Publisher: BioMed Central
Keyword: Care
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06248-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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