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Diabetes Mellitus, Type 2DiaMesterNCT07361640

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

A study testing e-health lifestyle program and Low calorie diet in people with Diabetes Mellitus, Type 2, run by Oslo University Hospital at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
e-health lifestyle program and Low calorie diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteNorway
Study dates
14 Jan 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anne-Marie Aas, PhD contact

+47 47302912

a.m.aas@medisin.uio.no

Lise M Østli, MSc contact

+47 97180196

l.m.ostli@medisin.uio.no

Norway1 site, 1 recruiting

  • Oslo University Hospital

    Oslo, 0424

    Anne-Marie Aas, Phd, +47 47302912, a.m.aas@medisin.uio.no

    Lise M Østli, MSc, +47 97180196, l.m.ostli@medisin.uio.no

    Recruiting

Other trials in Norway

About this study

Official title: 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).

Read the detailed description

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:

  1. 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

  1. 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

Being tested
e-health lifestyle program, Low calorie diet
Keywords
diabetes, diabetes mellitus type 2, e-health, self-management, weight loss, low calorie diet, remission induction, total diet replacement, caloric restriction, diet therapy, health psychology, eating disorder
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Weight Loss, Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-health lifestyle programBehavioural

    Also called Lifestyle intervention, e-health based intervention, m-health intervention, digital behavioural intervention

    The e-health lifestyle program consists of three parts:

    1. an educational digital course module that can be tailored to the users' individual needs and preferences. This will include videos and interactive webinars accessible through the program, hosted by health specialists with users as guests.
    2. individual and group-based digital lifestyle coaching by trained health care personnel through secure video-conference and chat solutions.
    3. a mobile-phone-based self-management app. This app will offer the user relevant data and information from glucometer and smart watch according to the users' needs and preferences as well as easy ways for recording dietary intake, physical activity and other relevant parameters.

  • Low calorie dietBehavioural

    Participants will use a low calorie diet (LCD) total diet replacement (TDR) for the first 3 months of the 1 year intervention period, before gradual reintroduction of food.

Study groups in NCT07361640
Study groupRoleWhat they receive
1ExperimentalE-health program with LCD
Receives: Behavioral: e-health lifestyle program; Behavioral: Low calorie diet
2ExperimentalE-health program without LCD
Receives: Behavioral: e-health lifestyle program
3No interventionStandard care, but with continuous glucose monitoring (CGM) for 10 days at baseline and 1 year.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight from baseline (weight loss)

    Body weight (kg) will be measured by the participants' GPs. Change in body weight will be reported as percentage weight loss and will be analysed as a continuous variable.

    Measured: Body weight will be assessed at baseline, 3 months, 6 months, 9 months and 12 months.

Secondary outcomes (13)

  1. Change in HbA1c from baseline

    HbA1c (mmol/mol) will be measured by the participants GPs and will be analysed as a continuous variable.

    Measured: HbA1c will be measured at baseline, 3 months, 6 months, 9 months and 12 months.

  2. Change in blood lipids from baseline

    Lipids (mmol/L) (total cholesterol, low density cholesterol, high density cholesterol, triglycerides, non-high density cholesterol) will be measured by the participants GPs and will be analysed as a continuous variable.

    Measured: Lipids will be measured at baseline, 6 months and 12 months

  3. Change in blood pressure from baseline

    Change in blood pressure (mmHg) will be measured by the participants GPs and will be analysed as a continuous variable.

    Measured: Blood pressure will be measured at baseline, 3 months, 6 months, 9 months and 12 months.

  4. Change in blood glucose time in range from baseline

    Average blood glucose will be collected form continuous glucose monitors (CGM).

    Measured: Participants' in the control group will wear a CGM for 10 days at baseline and 1 year, while participants' in the two intervention groups will wear a CGM for 40 days at baseline, 40 days at 6 months and 10 days at one year.

  5. Change in average blood glucose baseline

    Average blood glucose will be collected form continuous glucose monitors (CGM).

    Measured: Participants' in the control group will wear a CGM for 10 days at baseline and 1 year, while participants' in the two intervention groups will wear a CGM for 40 days at baseline, 40 days at 6 months and 10 days at one year.

  6. Change in use of medications from baseline

    Type of blood glucose lowering drugs, lipid lowering drugs and blood pressure lowering drugs. We will report how many participants that are using zero, one and more than one glucose lowering drug, lipid lowering drug and blood pressure lowering drug. In addition, we will report the number of participants that are using GLP-1 analogues.

    Measured: Use of medications will be assessed at baseline, 3 months, 6 months, 9 months and 12 months.

  7. Change in diet quality from baseline

    Data on diet quality will be collected using 24 hour recall for 3 separate days at each time point. The Norwegian Diet Index (1) will be adapted to create a new index reflecting the Norwegian dietary guidelines for diabetes and the European recommendations for the dietary management of diabetes (The Diabetes and Nutrition Study Group of the EASD 2023). In addition, intake of nutrients and key food groups will be evaluated.

    Measured: Diet quality will be assessed at baseline, 6 months and 1 year.

  8. Change in physical activity from baseline

    Physical activity will be scored on the short form of the International physical activity questionnaire (IPAQ-SF) (2). For participants in the intervention groups physical activity (energy expenditure and steps) will be recorded with smart watches.

    Measured: Physical activity will be assessed at baseline and 1 year follow up.

  9. Change in health related quality (HRQoL) of life from baseline

    HRQoL will be measured using the EQ-5D-5L (3).

    Measured: Measured at baseline and 1 year follow-up

  10. Change in diabetes distress of life from baseline

    Diabetes distress will be measured using the problem Areas in Diabetes Scale (PAID) (4) and/or the Diabetes Distress Scale (DDS) (5).

    Time frame: Measured at baseline and 1 year follow-up

    Measured: Measured at baseline and 1 year follow-up

  11. Change in diabetes self-management from baseline

    Diabetes self-management will be measured using the problem Diabetes Empowerment Scale-Short Form (DES-SF) (6).

    Measured: Measured at baseline and 1 year follow-up

  12. Change in eating disorder symptoms from baseline

    Eating disorder symptoms will be measured using the Eating Disorder Examination Questionnaire (EDE-Q) (7, 8). Individuals with a score indicating high likelihood of ED at baseline will undergo an interview evaluating diagnostic criteria.

    Measured: Measured at baseline and 1 year follow-up

  13. Prevalence of likely eating disorder at baseline

    Eating disorder symptoms will be measured using the problem EDE-Q. Individuals with a score indicating high likelihood of ED at baseline will undergo an interview evaluating diagnostic criteria.

    Measured: Measured at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start14 Jan 2026 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This registration covers a three-arm, parallel-group pilot RCT. Participants will be randomized in a 1:1:1 ratio to one of the two e-health lifestyle intervention arms or to the control group. The intervention and follow-up period is 1 year. The three arms include: 1. e-health program with an LCD TDR of 750-900 kcal/day for a 3-month induction phase, aiming at 10-15% weight loss within 12 months, 2. e-health program alone (without LCD) aiming at 10-15% weight loss within 12 months, 3. control group
Masking
None (open label)
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07361640
Sponsor's protocol ID
891668
Other IDs
SDAM_FOR555606
Acronym
DiaMester
Status last verified
Jan 2026
First submitted
15 Jan 2026
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared, as participants have not consented to data sharing beyond the purposes of the present study, and the data contain sensitive health information protected under GDPR.

Publications

  • Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.

    PubMed 7866415

  • Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF). Diabetes Care. 2003 May;26(5):1641-2. doi: 10.2337/diacare.26.5.1641-a. No abstract available.

    PubMed 12716841

  • Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.

    PubMed 15735199

  • Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.

    PubMed 7555499

  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PubMed 21479777

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694

  • Henriksen HB, Berg HB, Andersen LF, Weedon-Fekjaer H, Blomhoff R. Development of the Norwegian diet index and the Norwegian lifestyle index and evaluation in a national survey. Food Nutr Res. 2023 Sep 29;67. doi: 10.29219/fnr.v67.9217. eCollection 2023.

    PubMed 37808205

Questions about this trial

What is this clinical trial studying?

A study testing e-health lifestyle program and Low calorie diet in people with Diabetes Mellitus, Type 2, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne-Marie Aas, PhD (+47 47302912, a.m.aas@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight from baseline (weight loss) (time frame: Body weight will be assessed at baseline, 3 months, 6 months, 9 months and 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07361640, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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