Journal Article Randomized Controlled Trial Epublish
PubMed: 42342244 DOI: 10.2196/87692
Effect of a Personalized Mobile App on Glucose Control in Adults With Prediabetes and Type 2 Diabetes: Exploratory Pilot Randomized Controlled Trial.
JMIR Hum Factors 13:e87692
Authors: Elena Lalama, Marta Csanalosi, Stefan Kabisch, Saskia Wilson-Barnes, Lazaros P Gymnopoulos, Kosmas Dimitropoulos, Konstantinos Rouskas, Argiriou Anagnostis, Ioannis Oikonomidis, Leontios Hadjileontiadis, Veronique Cornelissen, Maria Hassapidou, Ioannis Pagkalos, Sofia Balula Dias, Kathryn Hart, Andreas F H Pfeiffer
Affiliations
- Department of Endocrinology and Metabolic Diseases, Charité - Universitätsmedizin Berlin, Berlin, Berlin, Germany.
- German Center for Diabetes Research, Neuherberg, Bavaria, Germany.
- School of Biosciences, Discipline: Nutrition, Food and Exercise Science, University of Surrey Faculty of Health and Medical Sciences, Surrey, United Kingdom.
- Information Technologies Institute, Centre for Research and Technology Hellas, Thessaloniki, Greece.
- Institute of Applied Biosciences, Centre for Research & Technology Hellas, Thessaloniki, Greece.
- INTRASOFT International (Greece), Athens, Attica, Greece.
- Department of Electrical and Computer Engineering, Aristotle University of Thessaloniki, Thessaloniki, Greece.
- Department of Rehabilitation Sciences, KU Leuven, Leuven, Flanders, Belgium.
- Department of Nutritional Sciences and Dietetics, International Hellenic University, Thessaloniki, Greece.
- Faculdade de Motricidade Humana, University of Lisboa, Lisbon, Lisbon, Portugal.
Abstract
BACKGROUND
The incidence of type 2 diabetes (T2D) continues to increase, and the lack of individualized therapy strategies hinders patient engagement with and commitment to a healthy lifestyle. The PROTEIN project aimed to facilitate users in choosing healthy living, thereby improving their metabolism and T2D management.
OBJECTIVE
This study aims to assess the efficacy of a personalized mobile app to achieve a 5% time in range (TIR) improvement over a 12-week intervention in adults with prediabetes or T2D.
METHODS
We conducted an exploratory pilot randomized controlled trial with 21 individuals with T2D or prediabetes who used a continuous glucose monitoring system and the PROTEIN mobile app for personalized meals and exercise recommendations based on their glucose levels and physical activity.
RESULTS
The TIR of the participants increased (P<.05; from 71.8%, SD 27.3% to 76%, SD 28.1%) with individual use of the PROTEIN app but did not achieve a 5% improvement overall; however, given the exploratory design and small sample size, this finding should be interpreted with caution. Glycated hemoglobin, fasting blood glucose, and body weight did not fluctuate throughout the 12-week intervention. The dropout rate was high, and the average duration of use of the PROTEIN app was 42 (range 5-84) days.
CONCLUSIONS
Our results showed a modest increase in TIR with the use of the PROTEIN app; however, considering the exploratory design and small sample size, this finding should be interpreted as preliminary. Integrating wearables and automated personalization for well-being is an innovative approach that must keep pace with the accelerated development of ever-evolving technologies. The COVID-19 pandemic was a major obstacle to recruitment in our clinical trial.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05951140; https://clinicaltrials.gov/study/NCT05951140.
MeSH
Diabetes Mellitus, Exercise, Sample Size, Pilots, Prediabetic State, Mobile Applications, Diabetes Mellitus, Type 2, Continuous Glucose Monitoring