Abstract / Summary
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).
Results: Ten participants (mean age 58.5, SD 7.4 y; mean BMI 35.3, SD 5.9 kg/m²; n=9 men and n=1 woman) were enrolled. After 6 months, 6 of 10 participants achieved the prespecified coprimary outcome of ≥15 kg weight loss, and all 10 participants achieved the prespecified coprimary outcome of diabetes remission. Mean weight loss was 16.9 (SD 5.4; P=.005) kg, and glycated hemoglobin decreased by 1.0% (SD 0.8%; P=.008). Daily home measurements showed a marked reduction in fasting glucose within the first week of the intervention. Median REE decreased by 19% (IQR 17%-22%), while median fasting RQ increased by 15% (IQR 5%-27%) and median post-glucose-load RQ increased by 12% (IQR 9%-18%) at 6 months.
Conclusions: In this pilot study, an eHealth-delivered TDR intervention was associated with substantial weight loss and diabetes remission at 6 months without the use of glucose-lowering medication. These findings support further evaluation of fully eHealth-delivered dietary interventions in larger and longer-term randomized controlled trials.