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

MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY): A Multi-National Randomised-Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes; Diabetes Distress
• Intervention / Treatment: Behavioral: MyDiaMate

Detailed Description

Rationale: Type 1 diabetes is a disease that asks constant attention, self-care activities and responsibility from the diagnosed person for the duration of their entire life. Because of this constant burden, many people with type 1 diabetes experience mental health problems such as fatigue, excessive worrying about their blood glucose (especially about dangerously low blood glucose), or eating problems. However, most people with type 1 diabetes who experience such symptoms do not receive professional help. This can have multiple reasons. Oftentimes, the problems are not severe enough to be classified as a disorder. Some people also prefer to work on the problems on their own, at their own pace. For people who experience mental health problems around their diabetes and to support them individually with as little barriers as possible, MyDiaMate was developed.

Objective: To investigate the effectiveness of MyDiaMate in reducing mental health problems in adults with type 1 diabetes who experience distress related to their disease across four countries (NL, DE, UK, ES).

Study design and procedure: Multi-national randomised-controlled trial (intervention : wait-list control group, randomised 2:1 per country).

After screening has confirmed study participation, participants will:

1. Complete the baseline assessment and be randomisation afterwards
2. Use MyDiaMate for 3 months in case of intervention group membership, or get care as usual in case of waitlist control group membership
3. At 3 months, all participants fill in the first follow-up assessment. Additionally, intervention group members will be asked about their satisfaction with and opinion on MyDiaMate (questionnaire and interviews).
4. All participants then receive access to MyDiaMate for the remaining 3 months of the study.
5. At 6 months, all participants complete the second follow-up assessment. Afterwards, the study ends for all participants and access to MyDiaMate is revoked.

Study population: Adults with type 1 diabetes who have been diagnosed more than 6 months ago and who experience distress in relation to their type 1 diabetes.

Intervention: The intervention group receives access to the online self-help programme MyDiaMate for 6 months. MyDiaMate is focused on mental health in type 1 diabetes. It includes psychoeducation and teaches coping strategies that are based on cognitive-behavioural therapy concepts. Moreover, videos in which people with type 1 diabetes talk about their experiences in coping with the disease are embedded in MyDiaMate. MyDiaMate users can also choose to make use of diaries and a module that helps with setting realistic goals. MyDiaMate can be accessed via a private mobile phone, tablet, or laptop/computer whenever wished. Because MyDiaMate is self-help, there is no schedule in when/how much participants should access MyDiaMate. Participants can make use of MyDiaMate as much as they want to, in a way that suits them best personally. Members in the waitlist control group receive access to MyDiaMate after 3 months, for 3 months, if so wished. They too can make use of MyDiaMate in a way that fits their personal time and needs best.

Main study parameters/endpoints: The main study outcome is change in diabetes distress in the intervention group between the baseline and the 3 months assessment. Secondary study outcomes are changes in emotional well-being, psychological self-efficacy in relation to diabetes, social engagement, and fatigue between the baseline and the 3 months assessment in participants from the intervention group. Moreover, in line with the secondary objective, the investigators will make use of MyDiaMate log data such as time spent in MyDiaMate and frequency of use in participants of the intervention group across the first 3 months and investigate in relation to the main and secondary outcomes as well as descriptive data such as age or gender, for which subgroup of MyDiaMate users the application programme is most effective.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks related to use of MyDiaMate. The burden of study participation is low, as participants are not instructed to use MyDiaMate in a certain way/intensity and filling in the non-invasive study questionnaires takes around 2 hr in total and is spread across 6 months. Both the intervention and control group have access to MyDiaMate during study participation (for 6 months in case of intervention group membership, for 3 months after 3 months in case of wait-list control group membership). Study participants benefit from study participation because they receive access to MyDiaMate, which may possibly help them with improving the diabetes-related mental health and teaches a variety of type 1 diabetes specific coping strategies, all of which is based on well-researched concepts of psychoeducation and cognitive behavioural therapy.

• Study Type: Interventional
• Enrollment (Estimated): 660
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Theresa Mohr, Msc; Phone Number: +3120444444; Email: myremedy@amsterdamumc.nl

Study Locations

• Germany
  • Baden-Württemberg
    • Bad Mergentheim, Baden-Württemberg, Germany, 97980
      • Forschungsinstitut Diabetes-Akademie Bad Mergentheim
      • Contact: Dominic Ehrmann; Phone Number: +4979319613839; Email: info@fidam.de
      • Principal Investigator: Dominc Ehrmann
      • Sub-Investigator: Gina Lehmann
      • Principal Investigator: Norbert Hermanns
• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081HV
      • Amsterdam UMC
      • Contact: Theresa Mohr, MSc; Phone Number: +31205669111; Email: myremedy@amsterdamumc.nl
      • Principal Investigator: Maartje de Wit, Dr.
      • Sub-Investigator: Theresa Mohr, MSc.
• Spain
  • Málaga, Spain, 29071
    • Universidad de Málaga
    • Contact: Maria Teresa Anarte; Phone Number: +34952131313; Email: info@uma.es
    • Principal Investigator: Maria Teresa Anarte
• United Kingdom
  • London, United Kingdom, WC2R 2LS
    • King's College London
    • Contact: Kirsty Winkley, Dr.; Phone Number: +4402078365454; Email: MyREMEDY@kcl.ac.uk
    • Principal Investigator: Kirsty Winkly, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; MyDiaMate programme
No Intervention: Care As Usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional well-being	Emotional well-being will be operationalised as the score on the 5-item World Health Organization Well-Being Index (=WHO-5). The score on the WHO-5 is measured on a 6-point scale ranging from 0 (At no time) to 5 (All of the time) with a lower score representing less 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	Operationalised through the Short form of the Diabetes Empowerment Scale (=DES-SF). Psychological self-efficacy in relation to diabetes is assessed on a 5-point scale ranging from 0 (Strongly disagree) to 4 (Strongly agree), with higher scores representing higher 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 assessed through the 6-item Lubben Social Network Scale (LSNS-6). The Lubben Social Network Scale measures Social Engagement on a 6-point scale ranging from 0 (None) to 5 (Nine or more). A higher score represents higher social engagement.	Social Engagement will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up)
Fatigue	Fatigue will be assessed through the 8-item Fatigue subscale of the Checklist Individual Strength (=CIS-F). The Fatigue subscale of the Checklist Individual Strength consists of both positively and negatively framed items that are measured on a 7-point scale ranging from 1 (No, that is not true) to 7 (Yes, that is true). The positively framed items (e.g., I feel fit) will be reverse coded. A higher score will therefore represent stronger fatigue.	Fatigue will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up)
HbA1c	Participants will self-report various outcome measures typical for assesseing glycaemic control in type 1 diabetes. One of these measures is the self-reported Haemoglobine A1c (=HbA1c) value. HbA1c will be measured on different scales, depending on clinical norms of the participating country. This will either be in percentage or mmol/mol. There is no formal minimum or maximum value of HbA1c, although realistically values will be in between 5 and 12 when measured in percentage, or 30 and 100 when measured in mmol/mol. For both scales, a lower score represents better glycaemic control. For data analysis, all scores measured in percentage will be transformed to a HbA1c value measured in mmol/mol.	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)
Time in/above/below range	Participants will self-report various outcome measures typical for assesseing glycaemic control in type 1 diabetes. One of these measures is the self-reported time in/above/below range. Participants can indicate their own personal target range for blood glucose values, and then indicate the percentage of time during which they were in, above, and below this personal range across the past 14 days. A higher percentage for time in range represents better glycaemic control. A lower percentage for time above range and time below range represents worse glycaemic control.	Glycaemic control measures, in this case time in/above/below range, will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up)
Events of ketoacidosis/severe hypoglycaemia	Participants will self-report various outcome measures typical for assesseing glycaemic control in type 1 diabetes. One of these measures is the self-reported frequency of events of ketoacidosis and severe hypoglycaemia across the past 12 months when measured at baseline, and across the past 3 months when measured at the 3 and 6 months assessment, respectively. A higher self-reported frequency of events of ketoacidosis and/or severe hypoglycaemia represents worse glycaemic control.	Glycaemic control measures, in this case frequency of events of ketoacidosis and severe hypoglycaemia, will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MyDiaMate usage data	We will passively collect data of MyDiaMate usage through the platform on which MyDiaMate is running (Minddistrict). In practice, we will record the minutes spent in the MyDiaMate application, specifically the minutes spent within each MyDiaMate module, for all members of the intervention group, for 3 months.	3 months

Collaborators and Investigators

• Sponsor: Maartje de Wit
• Collaborators: King's College London; Juvenile Diabetes Research Foundation; University of Malaga; Forschungsinstitut der Diabetes Akademie Mergentheim
• Investigators: Principal Investigator: Maartje de Wit, Dr., Amsterdam UMC, location VUmc

Publications and helpful links

Helpful Links

• MyREMEDY - Dutch research website

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; Self-help; e-health; Diabetes Distress
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2023.0714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will only be shared at reasonable request due to sensitive data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No