JMIR Publications

ABSTRACT

Background:

The DiRECT trial demonstrated that remission of type 2 diabetes can be achieved through substantial weight loss using a total diet replacement 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 total diet replacement intervention delivered solely via eHealth could induce clinically meaningful weight loss and achieve type 2 diabetes remission.

Methods:

This was a single-arm, non-blinded, 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 total diet replacement (~850 kcal/day) for 12 weeks, 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 two primary outcomes were a reduction in weight of 15 kg or more and remission of diabetes, defined as HbA1c <6.5% without glucose-lowering medication, from baseline to 6 months. A 75g oral glucose tolerance test (OGTT) 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 years; mean BMI 35.3 kg/m²; nine male and one female) were enrolled. After 6 months, six of ten participants achieved the primary outcome of ≥15.0 kg weight loss, and all ten participants achieved the primary outcome of diabetes remission and met the prespecified HbA1c-based remission criterion. Mean weight loss was 16.9 ± 5.4 kg (P=.005), and HbA1c decreased by 1.0 ± 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%, while median fasting RQ and post–glucose-load RQ increased by 16% at 6 months.

Conclusions:

In this pilot study, an eHealth-delivered total diet replacement 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. Clinical Trial: ClinicalTrials.gov (NCT4805996)