Type 1 DiabetesMyREMEDYNCT06308549
MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY)
A study testing MyDiaMate in people with Type 1 Diabetes and Diabetes Distress, run by Maartje de Wit at 4 sites in 4 countries.
Trial 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. 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
- 625 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 3 Apr 2024to 30 Jan 2026
- 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 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)
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
- 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)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Germany1 site
Forschungsinstitut Diabetes-Akademie Bad Mergentheim
Bad Mergentheim, Baden-Wurttemberg, 97980
United Kingdom1 site
King's College London
London, United Kingdom, WC2R 2LS
About this study
Official title: 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.
Read the 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:
- Complete the baseline assessment and be randomisation afterwards
- Use MyDiaMate for 3 months in case of intervention group membership, or get care as usual in case of waitlist control group membership
- 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).
- All participants then receive access to MyDiaMate for the remaining 3 months of the study.
- 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.
- Conditions
- Type 1 Diabetes, Diabetes Distress
- Being tested
- MyDiaMate
- Keywords
- Type 1 Diabetes, Diabetes Distress, Self-help, e-health
- 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 programme
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
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 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.
Measured: 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 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 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.
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 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.
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 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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start3 Apr 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maartje de Wit
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, King's College London, University of Malaga, Forschungsinstitut der Diabetes Akademie Mergentheim
- Responsible party
- Sponsor-investigator, Maartje de Wit, Amsterdam UMC, location VUmc
- Investigators
- Maartje de Wit, Dr., Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308549
- Sponsor's protocol ID
- 2023.0714
- Acronym
- MyREMEDY
- Status last verified
- Sep 2025
- First submitted
- 15 Feb 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be shared at reasonable request due to sensitive data.
Publications
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.
PubMed 39350441
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY): A Multi-National Randomised-Controlled Trial
- ClinicalTrials.gov ID
- NCT06308549
- Acronym / sponsor ID
- MyREMEDY / 2023.0714
- Conditions
- Type 1 Diabetes, Diabetes Distress
- Keywords
- Type 1 Diabetes, Diabetes Distress, Self-help, e-health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- Maartje de WitUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, King's College London, University of Malaga, Forschungsinstitut der Diabetes Akademie Mergentheim
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 13 Mar 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.
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.
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:
- Complete the baseline assessment and be randomisation afterwards
- Use MyDiaMate for 3 months in case of intervention group membership, or get care as usual in case of waitlist control group membership
- 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).
- All participants then receive access to MyDiaMate for the remaining 3 months of the study.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MyDiaMate2/3 of participants will be randomised into this arm. They will receive access to MyDiaMate in the language of their participation country for 6 months. |
| 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. |
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 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)
Key exclusion criteria (6 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
- Illiteracy
- 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 programme | Behavioural | Intervention |
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 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.
7 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: 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
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 39350441Mohr 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.
- MyREMEDY - Dutch research websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will only be shared at reasonable request due to sensitive data.
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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.
Maartje de Wit, Dr. principal investigator
Amsterdam UMC, location VUmc
4 sites in 4 countries: 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 Maartje de Wit at 4 sites in 4 countries.
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 6 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: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Netherlands, Spain, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT06308549, which also lists 1 linked publication.
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 2 Jul 2026.