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

Summary

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).

Eligibility

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

Conditions3

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