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Session: COVID-19 and Nutrition / Innovations in Telenutrition (Poster Theater Flash Session 10)

(PTFS10-05-23) Protocol of the Completely Remote Implementation of the Diabetes Telemedicine Mediterranean Diet Study, a Personalized Behavioral Intervention for Type 2 Diabetes

Monday, July 24, 2023
4:21 PM – 4:25 PM ET
Location:  Fairfax
Disclosure(s):
Josephine C. Wang, B.Sc. Nutrition: No relevant financial relationship(s) with ineligible companies to disclose.
Objectives: The Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study seeks to test a personalized behavioral intervention leveraging a gut microbiome-based machine learning algorithm for dietary management of type 2 diabetes (T2D). In this report, we aim to describe the approach to implement DiaTeleMed using completely remote methods.

Methods: DiaTeleMed is a 6-month, randomized clinical trial in adults with moderately controlled T2D. MyChart, an electronic health record, is used to recruit patients. Interested participants are pre-screened by phone to determine eligibility (21 to 80 years, T2D managed with lifestyle alone or lifestyle plus metformin). At a second screening via WebEx, participants are trained to use a mobile dietary app and complete a 7-day dietary self-monitoring run-in period followed by blood testing to confirm HbA1c of 6.0-8.0%. Eligible participants are randomized to one of three arms: Personalized, Standardized, or Usual Care Control (UCC) (N=300). Personalized is mailed a stool sample kit for gut microbiome analysis. All participants attend 4 weekly group-based WebEx education sessions, led by a registered dietician, on T2D management and the Mediterranean diet. UCC then receives links to 10 educational videos every other week, while Standardized and Personalized attend 10 one-hour WebEx group-based behavioral counseling sessions, anchored by brief, pre-recorded videos to ensure fidelity. All participants are instructed to self-monitor diet using the app which provides feedback on energy and macronutrient distribution. Personalized receives additional feedback on predicted postprandial glycemic response via algorithm-derived meal scores. Study staff maintain communication with participants to assess dietary self-monitoring progress, mail study materials, and instruct placement of continuous glucose monitors during videoconferenced study measurements (at 0, 3, and 6 months). The primary outcome is change in the mean amplitude of glycemic excursions from baseline to 6 months.

Results: Recruitment is currently ongoing with 32 participants randomized. We anticipate this clinical trial will be completed in 2025.

Conclusions: The remote methodologies implemented in this study may support scalability and reach of precision nutrition therapies.

Funding Sources: American Heart Association 17SFRN33590133