Diabetes Mellitus, Type 1NCT06203067
Type 1 Together: A Peer Mentorship Program to Bolster Use of CGM
A study testing Type 1 Together in people with Diabetes Mellitus, Type 1, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate a new way of helping adolescents with type 1 diabetes consistently use continuous glucose monitoring systems (CGM). Families who participate will be assigned by chance to one of two groups. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Type 1 Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12 to 17 years old
- Diagnosed with type 1 diabetes for at least 6 months
- Does not use CGM OR uses CGM < 24 out of the past 30 days
- Use CGM 24 to 30 of the past 30 days but most recent HbA1c was 9% or more
- Able to read and write in English
Who cannot join
- Type 1 diabetes due to other medical condition (e.g., cystic fibrosis)
- Intellectual disability
- Severe psychiatric comorbidities
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803
About this study
Official title: Type 1 Together: A Peer Mentorship Program to Bolster Use of Continuous Glucose Monitoring Systems Among Adolescents With Type 1 Diabetes
The goal of this clinical trial is to evaluate a new way of helping adolescents with type 1 diabetes consistently use continuous glucose monitoring systems (CGM).
Families who participate will be assigned by chance to one of two groups. One group will continue to see their Endocrinology provider who can give recommendations on ways to use CGM.
Read more
The other group will be in our Type 1 Together program for 6 months. This will include:
- Monthly meetings with a community health worker with expertise in type 1 diabetes self-management,
- Access to CGM-specific educational resources hosted on a mobile app, and
- Meeting at least monthly with a mentor family who will provide mentorship on using CGM consistently.
The main questions the study aims to answer are:
- Do families like the Type 1 Together program?
- Do more families in the Type 1 Together program have better attitudes towards CGM, use CGM more consistently, and have lower HbA1c?
- Does the Type 1 Together program reduce racial and ethnic differences in attitudes towards CGM, consistent use of CGM, and HbA1c?
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Standard of Care, Type 1 Together
- 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.
Standard of CareBehavioural
Quarterly clinic visits with endocrinology provider.
Type 1 TogetherBehavioural
In Type 1 Together, families will work with other families who have experience using CGM (Peer Mentors) to overcome common barriers to CGM use. Families in the Type 1 Together program will also have access to CGM-specific educational materials, a digital journal to facilitate patient-provider communication around issues with CGM, and social determinant of health screening and intervention with a diabetes community health worker.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Together | Experimental | In Type 1 Together, families will work with other families who have experience using CGM (Peer Mentors) to overcome common barriers to CGM use. Families in the Type 1 Together program will also have access to CGM-specific educational materials, a digital journal to facilitate patient-provider communication around issues with CGM, and social determinant of health screening and intervention with a diabetes community health worker. Receives: Behavioral: Type 1 Together |
| Standard of Care | Active comparator | Quarterly clinic visits with endocrinology provider. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability
How acceptable youth and caregivers find Type 1 Together. This information will be collected only from participants in the experimental arm using the Acceptability of Intervention Measure (scores range 1-5 with higher scores indicating greater acceptability).
Measured: 6 months post-enrollment
Perceptions of continuous glucose monitoring systems
Youth perceptions of the benefits and burdens of using continuous glucose monitoring systems will be assessed using the CGM Benefits and Burdens Scales (scores range 1-5 with higher scores indicating greater perceived benefits or burdens).
Measured: Baseline and 3, 6, 9, and 12 months post-enrollment.
Continuous Glucose Monitoring System Use
The number of days a patient wore their continuous glucose monitoring system at least 12 hours over the past month.
Measured: Baseline and 3, 6, 9, and 12 months post-enrollment
HbA1c
HbA1c expressed as a percentage of glycosylated hemoglobin
Measured: Baseline and 3, 6, 9, and 12 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start19 Apr 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Paul Enlow, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203067
- Sponsor's protocol ID
- 1990806
- Other IDs
- P20GM144270, 5438
- Status last verified
- Feb 2026
- First submitted
- 2 Jan 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Together: A Peer Mentorship Program to Bolster Use of Continuous Glucose Monitoring Systems Among Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06203067
- Acronym / sponsor ID
- 1990806
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 12 Jan 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 goal of this clinical trial is to evaluate a new way of helping adolescents with type 1 diabetes consistently use continuous glucose monitoring systems (CGM).
Families who participate will be assigned by chance to one of two groups. One group will continue to see their Endocrinology provider who can give recommendations on ways to use CGM.
The other group will be in our Type 1 Together program for 6 months. This will include:
- Monthly meetings with a community health worker with expertise in type 1 diabetes self-management,
- Access to CGM-specific educational resources hosted on a mobile app, and
- Meeting at least monthly with a mentor family who will provide mentorship on using CGM consistently.
The main questions the study aims to answer are:
- Do families like the Type 1 Together program?
- Do more families in the Type 1 Together program have better attitudes towards CGM, use CGM more consistently, and have lower HbA1c?
- Does the Type 1 Together program reduce racial and ethnic differences in attitudes towards CGM, consistent use of CGM, and HbA1c?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Together | Experimental | Behavioral: Type 1 TogetherIn Type 1 Together, families will work with other families who have experience using CGM (Peer Mentors) to overcome common barriers to CGM use. Families in the Type 1 Together program will also have access to CGM-specific educational materials, a digital journal to facilitate patient-provider communication around issues with CGM, and social determinant of health screening and intervention with a diabetes community health worker. |
| Standard of Care | Active comparator | Behavioral: Standard of CareQuarterly clinic visits with endocrinology provider. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 12 to 17 years old
- Diagnosed with type 1 diabetes for at least 6 months
- Does not use CGM OR uses CGM < 24 out of the past 30 days
- Use CGM 24 to 30 of the past 30 days but most recent HbA1c was 9% or more
- Able to read and write in English
Key exclusion criteria (3 listed)
- Type 1 diabetes due to other medical condition (e.g., cystic fibrosis)
- Intellectual disability
- Severe psychiatric comorbidities
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 |
|---|---|---|
| Standard of CareQuarterly clinic visits with endocrinology provider. | Behavioural | Standard of Care |
| Type 1 TogetherIn Type 1 Together, families will work with other families who have experience using CGM (Peer Mentors) to overcome common barriers to CGM use. Families in the Type 1 Together program will also have access to CGM-specific educational materials, a digital journal to facilitate patient-provider communication around issues with CGM, and social determinant of health screening and intervention with a diabetes community health worker. | Behavioural | Type 1 Together |
Primary outcome
Intervention Acceptability
Time frame: 6 months post-enrollment
How acceptable youth and caregivers find Type 1 Together. This information will be collected only from participants in the experimental arm using the Acceptability of Intervention Measure (scores range 1-5 with higher scores indicating greater acceptability).
Perceptions of continuous glucose monitoring systems
Time frame: Baseline and 3, 6, 9, and 12 months post-enrollment.
Youth perceptions of the benefits and burdens of using continuous glucose monitoring systems will be assessed using the CGM Benefits and Burdens Scales (scores range 1-5 with higher scores indicating greater perceived benefits or burdens).
Continuous Glucose Monitoring System Use
Time frame: Baseline and 3, 6, 9, and 12 months post-enrollment
The number of days a patient wore their continuous glucose monitoring system at least 12 hours over the past month.
HbA1c
Time frame: Baseline and 3, 6, 9, and 12 months post-enrollment
HbA1c expressed as a percentage of glycosylated hemoglobin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type 1 Together in people with Diabetes Mellitus, Type 1, run by Nemours Children's Clinic at 1 site in United States.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. 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 States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Intervention Acceptability (time frame: 6 months post-enrollment). The study lists 4 primary outcomes in all. 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 5 Feb 2026.