DiaMester Pilot RCT: E-health Lifestyle Program for Type 2 Diabetes

DiaMester: E-health Lifestyle Program for Improved Self-management and Remission of Type 2 Diabetes - a Pilot RCT

This registration covers a pilot for a 3-armed parallel-group randomized controlled trial (RCT) that will evaluate the efficacy of DiaMester, a Norwegian e-health programme designed to improve self-management and induce clinically meaningful weight loss, and thereby potential remission in adults with type 2 diabetes (T2D).

The aim of this pilot RCT is to test the feasibility of the program and to investigate to what extent the program contributes to the intended improvement in lifestyle, self-management, metabolic risk factors and body weight. We also aim to investigate if participants in the e-health program achieve a clinically meaningful weight loss in each of the two intervention arms: one including a low-calorie diet (LCD) total diet replacement (TDR) induction phase and one without the use of a LCD.

The DiaMester app serves as a secure communication platform between each participant and an assigned health coach, who provides individually tailored advice on diet and physical activity and monitors progress towards agreed weight-loss targets. Six health coaches (clinical dietitians or diabetes nurses) will deliver the intervention, each having completed the same standardized training prior to study start.

Hypotheses:

Primary objective: To test whether participation in the DiaMester e-health program with an LCD induction phase results in greater weight loss compared to usual care after 12 months.

H1: The e-health + LCD group will achieve greater weight loss after 12 months than the control group

Secondary objectives:

A. To test whether participation in the DiaMester e-health program alone (without LCD) results in greater weight loss compared to usual care after 12 months.

H2: The e-health-only group will achieve greater weight loss than the control group after 12 months

B. Secondary outcomes include diet quality, lifestyle, physical activity, metabolic risk factors, and health related quality of life (HRQoL), self-management, eating disorder symptoms and diabetes distress. Both the LCD and no LCD intervention groups will be compared with the control group (usual care).

We hypothesize that compared to usual care, the e-health program supported lifestyle interventions will H3: Improve diet quality (in line with dietary recommendations), lifestyle index score and increase participants' physical activity H4: Improve the metabolic risk factors HbA1c, blood lipids, and blood pressure, H5: Reduce the use of blood glucose/lipid lowering drugs and/or blood pressure lowering drugs H5: Increase HRQoL and self-management and lower the level of diabetes distress.

H6: Not increase eating disorder symptoms

C: To examine possible mediating and moderating factors for the effect on body weight and metabolic risk factors H6: The intervention's effect on bodyweight is mediated by change in diet quality and physical activity H7: The intervention's effect on HbA1c, blood lipids and blood pressure is mediated by change in bodyweight, diet quality and physical activity H8: The effect of weight loss on HbA1c is moderated by diabetes duration, BMI and age

Inclusion Criteria:

• Written informed consent
• Men and women aged ≥ 18 years
• Type 2 diabetes of duration 0-6 years (diagnosis based on 2 recorded diagnostic-level tests, HbA1c and/or blood glucose)
• HbA1c ≥ 48 mmol/mol at the last routine clinical check, within last 12 months if on diet alone
• HbA1c ≥ 43 mmol/mol if on treatment with oral hypoglycaemic agents or GLP-1 RA treatment
• Body Mass Index (BMI) >27 kg/m2
• Stable body weight during the last 6 months with or without the use of weight-reducing drugs
• Self-reported desire to lose weight
• Owns a smartphone

Exclusion criteria:

• Current insulin use
• > 5% weight change or started treatment with weight reducing drugs* within the last 6 months. *orlistat (Xenical), bupropion-naltrekson (Mysimba), fenteramin-topiramat (Qsimba), semaglutid (Wegovy, Ozempic), tirzepatid (Mounjaro), liraglutid (Saxenda, Victoza), dulaglutid (Truicity).
• Recent routine HbA1c ≥108 mmol/mol
• Recent eGFR <30 ml/min/1.73 m^2
• Known cancer
• Myocardial infarction within previous 6 months
• Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA)
• Pregnancy/considering pregnancy or exclusively breastfeeding
• Substance abuse (drugs, alcohol)
• Diagnosed eating disorders or suspected ED based on screening questionnaire
• Learning difficulties or unable to understand, speak and read Norwegian or English
• Patients who have required hospitalization for depression or are on antipsychotic drugs
• People currently participating in another clinical research trial