MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY)

NCT06308549 | Active Not Recruiting

• 1 other identifier: 2023.0714
• Study Type: interventional
• Target: 660
• Locations: 4 countries
• Sites: 4

Brief Summary

In the MyREMEDY study the investigators research whether the MyDiaMate self-help application is effective in strengthening the mental health of adults with type 1 diabetes in comparison with care as usual. The MyREMEDY study takes place in four countries: The Netherlands, United Kingdom, Spain, and Germany.

Conditions

Type 1 Diabetes; Diabetes Distress

Keywords

Type 1 Diabetes; Diabetes Distress; Self-help; e-health

Outcome Measures

Primary Outcomes (1)

• Diabetes Distress

  Diabetes Distress will be assessed through the 20-item Problem Areas In Diabetes questionnaire (=PAID-20). The Problem Areas In Diabetes questionnaire measures diabetes distress on a 5-point Likert scale ranging from 1 (Not a problem) to 5 (Serious Problem). A higher score represents higher diabetes distress.

  Diabetes Distress will be assessed at 0 months (baseline), 3 months (intervention effects), and after 6 months (follow-up).

Secondary Outcomes (7)

• Emotional well-being

  Emotional well-being will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).

• Psychological self-efficacy in relation to diabetes

  Psychological self-efficacy in relation to diabetes will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).

• Social Engagement

  Social Engagement will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up)

• Fatigue

  Fatigue will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up)

• HbA1c

  Glycaemic control measures, in this case Haemoglobine A1c, will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up)

Other Outcomes (1)

• MyDiaMate usage data

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

2/3 of participants will be randomised into this arm. They will receive access to MyDiaMate in the language of their participation country for 6 months.

Behavioral: MyDiaMate

Care As Usual

NO INTERVENTION

1/3 of participants will be randomised into this arm. They will receive Care As Usual, so no intervention, for 3 months. After 3 months, they receive access to MyDiaMate, if so wished.

Interventions

MyDiaMate BEHAVIORAL

MyDiaMate programme

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old at signing the informed consent form
• Type 1 diabetes diagnosis at least 6 months ago
• Having access to the internet and a smartphone/tablet/laptop'/computer for the entire time of study participation
• Experiencing diabetes distress (checked during a phone call between research assistant and participant. The condition is met if the participant has an average score of ≥2 on the 2-item Diabetes Distress Scale (DDS-2), representing clinically meaningful diabetes distress)

You may not qualify if:

• Having been diagnosed with a psychiatric disorder in the past 6 months for which the person is under psychological/psychiatric treatment
• Suicidality
• Having started a treatment with psychotropic medication in the past 3 months
• Illiteracy
• Experience of cognitive problems that hamper using MyDiaMate or vision/auditory problems that are hindering in daily life
• Prior use of MyDiaMate (only applicable to participants in the Netherlands)

Sponsors & Collaborators

• Maartje de Wit: lead
• Juvenile Diabetes Research Foundation: collaborator
• King's College London: collaborator
• University of Malaga: collaborator
• Forschungsinstitut der Diabetes Akademie Mergentheim: collaborator

Study Sites (4)

Forschungsinstitut Diabetes-Akademie Bad Mergentheim

Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

Location

Amsterdam UMC

Amsterdam, North Holland, 1081HV, Netherlands

Location

Universidad de Málaga

Málaga, Spain, 29071, Spain

Location

King's College London

London, United Kingdom, WC2R 2LS, United Kingdom

Location

Related Publications (1)

• Mohr TC, de Wit M, Embaye J, Ehrmann D, Hermanns N, Lehmann G, Anarte Ortiz MT, Torreblanca Murillo L, Winkley K, Famiglietti A, Pouwer F, Snoek FJ. Effectiveness of the MyDiaMate application in reducing diabetes distress in adults with type 1 diabetes: Study protocol of the multi-national, randomised-controlled MyREMEDY trial. Diabet Med. 2025 Jan;42(1):e15442. doi: 10.1111/dme.15442. Epub 2024 Sep 30.

  PMID: 39350441 DERIVED

Related Links

• MyREMEDY - Dutch research website

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maartje de Wit, Dr.

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 13, 2024
• Study Start: April 3, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); NL (1); DE (1); GB (1)