Type 1 DiabetesUK-MyREMEDYNCT06448338
UK MyREMEDY Clinical Trial
A study testing MyDiaMate in people with Type 1 Diabetes and Diabetes Distress, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Diabetes Distress
- What is being tested?
- MyDiaMate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Sufyan Hussain, MA, MB BChir, MRCP, PhD, +4402071881916, sufyan.hussain@gstt.nhs.uk
About this study
Official title: MyDiaMate for Remission of Elevated Diabetes Distress in Type 1 Diabetes: the UK MyREMEDY Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Type 1 Diabetes, Diabetes Distress
- Being tested
- MyDiaMate
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyDiaMateBehavioural
MyDiaMate program
| Study group | Role | What they receive |
|---|---|---|
| MyDiaMate | Experimental | 2/3 of participants will be randomized into this arm. They will receive access to MyDiaMate for 6 months. Receives: Behavioral: MyDiaMate |
| Care as Usual | No intervention | 1/3 of participants will be randomized into this arm. They will continue their care as usual for 3 months. After 3 months, they receive access to MyDiaMate if desired. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress
Diabetes Distress will be assessed through the 20-item Problem Areas In Diabetes questionnaire (PAID-20). The PAID 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.
Measured: Diabetes Distress will be assessed at 0 months (baseline), 3 months (intervention effects), and after 6 months (follow-up).
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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 LSNS measures social engagement on a 6-point scale ranging from 0 (none) to 5 (nine or more). A higher score represents higher social engagement.
Measured: 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 CIS-F 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.
Measured: 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 assessing glycemic control in type 1 diabetes. One of these measures is the self-reported glycated hemoglobin (HbA1c) value. A lower score represents better glycemic control. For data analysis, all scores measured in percentage will be transformed to a HbA1c value measured in mmol/mol.
Measured: HbA1c 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 assessing glycemic 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 glycemic control. A lower percentage for time above range and time below range represents worse glycemic control.
Measured: 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
Participants will self-report various outcome measures typical for assessing glycemic control in type 1 diabetes. One of these measures is the self-reported frequency of events of ketoacidosis in the past 12 months when measured at baseline, and in the past 3 months when measured at the 3 and 6 months assessment, respectively. A higher self-reported frequency of events of ketoacidosis represents worse glycemic control.
Measured: Frequency of events of ketoacidosis will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up).
Events of severe hypoglycemia
Participants will self-report various outcome measures typical for assessing glycemic control in type 1 diabetes. One of these measures is the self-reported frequency of events of severe hypoglycemia in the past 12 months when measured at baseline, and in the past 3 months when measured at the 3 and 6 months assessment, respectively. A higher self-reported frequency of events of severe hypoglycemia represents worse glycemic control.
Measured: Frequency of events of severe hypoglycemia will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Forschungsinstitut der Diabetes Akademie Mergentheim, University of Malaga
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448338
- Sponsor's protocol ID
- 329634
- Other IDs
- RMS360
- Acronym
- UK-MyREMEDY
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyDiaMate for Remission of Elevated Diabetes Distress in Type 1 Diabetes: the UK MyREMEDY Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06448338
- Acronym / sponsor ID
- UK-MyREMEDY / 329634
- Conditions
- Type 1 Diabetes, Diabetes Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Forschungsinstitut der Diabetes Akademie Mergentheim, University of Malaga
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyDiaMate | Experimental | Behavioral: MyDiaMate2/3 of participants will be randomized into this arm. They will receive access to MyDiaMate for 6 months. |
| Care as Usual | No intervention | –1/3 of participants will be randomized into this arm. They will continue their care as usual for 3 months. After 3 months, they receive access to MyDiaMate if desired. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyDiaMateMyDiaMate program | Behavioural | MyDiaMate |
Primary outcome
Diabetes Distress
Time frame: Diabetes Distress will be assessed at 0 months (baseline), 3 months (intervention effects), and after 6 months (follow-up).
Diabetes Distress will be assessed through the 20-item Problem Areas In Diabetes questionnaire (PAID-20). The PAID 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.
8 secondary outcomes
Emotional well-being
Time frame: 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
Time frame: 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
Time frame: Social engagement will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).
Fatigue
Time frame: Fatigue will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).
HbA1c
Time frame: HbA1c will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up).
Time in/above/below range
Time frame: 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
Time frame: Frequency of events of ketoacidosis will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up).
Events of severe hypoglycemia
Time frame: Frequency of events of severe hypoglycemia will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Link to study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyDiaMate in people with Type 1 Diabetes and Diabetes Distress, run by King's College London at 1 site in United Kingdom.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsty Winkley, PhD (+447879625607, MyREMEDY@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Distress (time frame: Diabetes Distress will be assessed at 0 months (baseline), 3 months (intervention effects), and after 6 months (follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2024.