Clinical trial NCT06448338: UK MyREMEDY Clinical Trial
Official title: MyDiaMate for Remission of Elevated Diabetes Distress in Type 1 Diabetes: the UK MyREMEDY Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Diabetes Distress
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Forschungsinstitut der Diabetes Akademie Mergentheim
name: University of Malaga
First posted: 2024-06-07
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The UK MyREMEDY study investigates whether MyDiaMate, an online self-help program, can effectively improve the mental health of adults with type 1 diabetes compared to those receiving care as usual.

Detailed description: The psychological burden of living with and self-managing type 1 diabetes is well-recognized. Nevertheless, access to mental health services for people with type 1 diabetes is generally limited, even in well-resourced settings. Digital solutions or e-mental health, a rapidly expanding field, offer a complement to existing services. However, while many apps target glucose and lifestyle, particularly for type 2 diabetes, few digital tools focusing on healthy coping and mental health for type 1 diabetes exist. MyDiaMate was developed to alleviate this deficiency and its effectiveness (in terms of reduction of diabetes distress among people with type 1 diabetes) will be evaluated by this study. UK MyREMEDY is conducted in conjunction with a wider evaluation of MyDiaMate in the Netherlands, Spain, and Germany.

Previously, an observational pilot study in the Netherlands demonstrated the acceptability and feasibility of MyDiaMate and additionally suggested positive effects on mental health. Nevertheless, MyDiaMate has not been evaluated in a UK setting. The principal research objective of this study is to determine the effectiveness of MyDiaMate over time in adults with type 1 diabetes. This will be assessed in terms of improvement of mental health, with diabetes distress as primary outcome, relative to care as usual.

The effectiveness of MyDiaMate will be tested in a two-arm parallel randomized controlled trial. This study design will allow researchers to assess differences in mental health, diabetes self-care, and glycemic control in participants using MyDiaMate versus participants undergoing care as usual (randomized 2:1).

The study population will consist of adults with type 1 diabetes in the UK who were diagnosed at least 6 months prior and who experience distress related to their diabetes. After participants are screened for eligibility and confirm their participation in the study, they will complete a baseline assessment and be randomized to the intervention or control group. For their first 3 months of participation, the control group will receive care as usual, while the participants in the experimental group will be given access to MyDiaMate via an online link. After 3 months, all participants irrespective of randomized groups will be given access to MyDiaMate. Access to MyDiaMate will end after 6 months of study participation. All participants will additionally be asked to complete several online, self-reported measures of primary and secondary outcomes at baseline, three months, and six months.

MyDiaMate offers online modules centered around common sources of diabetes distress, such as the disruptive impact of stress on blood glucose, fear of hypoglycemia, worries about complications, disordered eating, and stressful social interactions, as well as low wellbeing and fatigue. Grounded in principles of cognitive behavioral therapy, MyDiaMate includes psycho-education and coping strategies, presented in a variety of formats, including written content, videos, diaries, and other activities. The participants can access the program on their personal device as often as wished for the duration of the study with no prescribed frequency of use.

Participation in this study is low risk and participants have the opportunity to engage with MyDiaMate as much as desired. Completion of the study questionnaires is estimated to take 2 hours, spread across the participation period (6 months). The participants may benefit from use of MyDiaMate and experience improved mental health and reduced diabetes distress.

After the study has concluded in the UK, the investigators will share the anonymized data with the research team of the international MyREMEDY clinical trial. Subsequent pooled analyses will contribute to complete evaluation of MyDiaMate and the further support of the mental wellbeing of people with type 1 diabetes.

Eligibility criteria: 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 entirety 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
* Cannot read and speak English
* Experience of cognitive problems that hamper using MyDiaMate or vision/auditory problems that are hindering in daily life

Primary outcomes:
measure: Diabetes Distress
timeFrame: Diabetes Distress will be assessed at 0 months (baseline), 3 months (intervention effects), and after 6 months (follow-up).
Secondary outcomes:
measure: Emotional well-being
timeFrame: Emotional well-being will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).
measure: Psychological self-efficacy in relation to diabetes
timeFrame: Psychological self-efficacy in relation to diabetes will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).
measure: Social engagement
timeFrame: Social engagement will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).
measure: Fatigue
timeFrame: Fatigue will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).
measure: HbA1c
timeFrame: HbA1c will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up).
measure: Time in/above/below range
timeFrame: Time in/above/below range will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up).
measure: Events of ketoacidosis
timeFrame: Frequency of events of ketoacidosis will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up).
measure: Events of severe hypoglycemia
timeFrame: Frequency of events of severe hypoglycemia will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up).
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
References: