JMIR diabetes
An eHealth-Delivered Total Diet Replacement Intervention for Type 2 Diabetes Remission: Single-Arm Pilot Study
By Chninou Y, Edholm J, Engvall J and 4 others.
Abstract
Background
The Diabetes Remission Clinical Trial (DiRECT) demonstrated that remission of type 2 diabetes can be achieved through substantial weight loss using a total diet replacement (TDR) intervention combined with structured support. Whether this approach can be delivered exclusively via eHealth has not been well studied.
Objective
This pilot study aimed to evaluate whether a TDR intervention delivered solely via eHealth could induce clinically meaningful weight loss and achieve type 2 diabetes remission.
Methods
This was a single-arm, nonblinded, single-center pilot study conducted at the clinical research facilities of Umeå University Hospital. Individuals with type 2 diabetes diagnosed within the past 6 years were included. Participants followed a TDR (~850 kcal/d) for 12 weeks, and then gradually reintroduced food, with a total study duration of 6 months. Diabetes medications were discontinued at the start of the study. Daily body weight and fasting glucose were measured at home and transmitted to the study team via connected devices. All clinical support was delivered through video calls and chat. The 2 prespecified coprimary outcomes were a reduction in weight of 15 kg or more and remission of diabetes, defined as glycated hemoglobin below 6.5% without glucose-lowering medication, from baseline to 6 months. A 75 g oral glucose tolerance test and indirect calorimetry were performed at baseline and at 6 months to assess resting energy expenditure (REE) and respiratory quotient (RQ).