DiaMester e-health lifestyle program for adults with type 2 diabetes (pilot)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a three-armed, parallel-group randomized pilot comparing usual care to an e-health coaching program alone and the same program plus a low-calorie total diet replacement induction phase. Adults with recent-onset type 2 diabetes, BMI >27 kg/m2, and smartphone access will be randomized and followed for 12 months to measure weight change, self-management behaviors, and metabolic risk markers. The DiaMester app provides secure messaging with one of six trained health coaches (dietitians or diabetes nurses) who deliver tailored diet and activity support and monitor progress toward agreed weight targets. The pilot focuses on feasibility and whether the program achieves clinically meaningful weight loss and related metabolic improvements compared with usual care.

Why it matters

Who can join: the full rules

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

Where it's running

• Oslo University Hospital
  Oslo, Norway Recruiting

Study contacts

• Principal investigator: Anne-Marie Aas, PhD — Oslo University Hospital and University of Oslo
• Study coordinator: Anne-Marie Aas, PhD
• Email: a.m.aas@medisin.uio.no
• Phone: +47 47302912

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Proliverenol for liver fat and insulin resistance in type 2 diabetes

  This study tests whether adding Proliverenol to standard diabetes care can improve liver fat and blood sugar control in adults with type 2 diabetes.

  Recruiting Phase 2 Universitas Sriwijaya · Palembang, South Sumatera · NCT07928661

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

• Safety test of NNC9836-0001 in adults with overweight/obesity or type 2 diabetes

  This study tests whether the new medicine NNC9836-0001 is safe and tolerable in adults who are overweight or have type 2 diabetes, compared to placebo.

  Recruiting Phase 1 Novo Nordisk A/S · Neuss · NCT07896109

• RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes

  This study tests the accuracy and safety of the RIGHTEST iFree 2 continuous glucose monitor in pregnant adults with type 1, type 2, or gestational diabetes.

  Recruiting Bionime Corporation · Ulm, Baden-Wurttemberg · NCT07889388

• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

  Recruiting Phase 3 Eli Lilly and Company · Tucson, Arizona and 74 other locations · NCT07881458

• Maridebart cafraglutide vs. semaglutide for type 2 diabetes on metformin

  This trial tests whether maridebart cafraglutlide is as good as semaglutide at improving blood sugar in adults with type 2 diabetes who take metformin (with or without an SGLT-2 inhibitor).

  Recruiting at 8 sites Phase 3 Amgen · San Diego, California and 7 other locations · NCT07866066

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.