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Type 1 DiabetesGlu-COACHNCT06171412

Glu-COACH: a Peer-mentoring Intervention to Reduce Disparities in Continuous Glucose Monitor (CGM) Use

A study testing Glu-COACH in people with Type 1 Diabetes, run by Yale University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a study to develop and evaluate a peer mentoring intervention for Black and Latinx adolescents with type 1 diabetes to increase the initiation and maintenance of a continuous glucose monitoring (CGM) device. Read more about this study

Who is it for?
Ages 13 to 21 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Glu-COACH
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
21 May 2024to 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 13 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosis of type 1 diabetes, as determined clinically by the presence of ketosis or ketoacidosis at presentation and/or the presence of at least one diabetes-related auto-antibody
  • Self-identification as Black and/or Latinx.
  • Ability of participant to comprehend and communicate in written and spoken English, in order to complete surveys and participate in mentioning sessions and other interview (parents/caregivers do not need to have English fluency)
  • Access to personal cellphone or tablet to participate in remote video sessions with the peer mentor
  • using CGM <50% of the time over the last 3 months

Who cannot join

  • Participants with a prior severe skin reaction to CGM sensor or adhesive.
  • Current use of CGM
  • Current or planned pregnancy
  • Inability to comprehend or communicate in spoken/written English
  • Subjects with other medical or mental health conditions that would, in the opinion of the investigators, interfere with the conduct of the study or present additional risk to the individual.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stuart A Weinzimer, MD contact

877.925.3637

stuart.weinzimer@yale.edu

Robin Whittemore, PhD, APRN, FAAN contact

203-737-2351

robin.whittemore@yale.edu

United States1 site, 1 recruiting

  • Yale Children's Diabetes Clinic

    New Haven, Connecticut, 06520

    Recruiting

Other trials in United States

About this study

This is a study to develop and evaluate a peer mentoring intervention for Black and Latinx adolescents with type 1 diabetes to increase the initiation and maintenance of a continuous glucose monitoring (CGM) device. This device is a standard of care to improve diabetes management related to diet, exercise, and insulin. Use of CGM has been shown to improve health outcomes, but is not used by adolescents of color. Peer mentors may help improve usage.

Read the detailed description

In Phase 1, investigators developed the intervention with a stakeholder advisory group. In Phase 2, investigators will conduct a small clinical trial to evaluate the intervention. Phase 1 is complete with the focus of this registration being Phase 2, the clinical trial.

All study procedures will be conducted remotely by ZOOM, including consent/assent, device and training, and peer mentor sessions.

Conditions
Type 1 Diabetes
Being tested
Glu-COACH
Keywords
continuous glucose monitor
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.

  • Glu-COACHBehavioural

    peer-mentoring support from a peer of the same cultural identity and access to a private social media group for all Black and Latinx teens

Study groups in NCT06171412
Study groupRoleWhat they receive
Glu-COACHExperimentalThe experimental group will receive ESOC plus peer-mentoring support from a peer of the same cultural identity (Glu-COACH) and access to a private social media group for all Black and Latinx teens to improve the initiation and maintenance of CGM (Dexcom)
Receives: Behavioral: Glu-COACH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean hours per week CGM worn

    Mean hours per week of documented CGM wear. This will be documented through the CGM program. The primary analysis will be CGM use time at 6 months between the two groups.

    Measured: 3 months and 6 months

Secondary outcomes (14)

  1. CGM Mean glucose

    The mean glucose in mg/dL

    Measured: baseline, 3 months and 6 months

  2. CGM Percentage time in range (70-180mg/dL)

    Percentage of time participants glucose values are in the target range of 70-180 mg/dL

    Measured: baseline, 3 months and 6 months

  3. Mean A1C concentration

    Mean A1C concentration

    Measured: baseline, 3 months and 6 months

  4. Number of Adverse diabetes-related events (diabetic ketoacidosis)

    Number of Yes/no responses via self report of diabetic ketoacidosis

    Measured: baseline, 3 months and 6 months

  5. Number of Adverse diabetes-related events (severe hypoglycemia)

    Number of Yes/no responses via self report of severe hypoglycemia

    Measured: baseline, 3 months and 6 months

  6. Mean score in Diabetes Distress using Problem Areas in Diabetes-Teen (PAID-T) survey

    PAID-T is a 26 item survey that measures of diabetes-specific distress for teenagers with type 1 diabetes. Items are rated on a 6-point Likert scale: 1-2, not a problem; 3-4, a moderate problem; or 5-6, a serious problem. Item scores are summed to form a total score (range 26-156), with higher scores indicating greater distress.

    Measured: baseline, 3 months and 6 months

  7. Mean score Diabetes self-efficacy using Diabetes Management Self-Efficacy scale (DMSES)

    Measures the diabetic patients confidence regarding diet, exercise and medical treatment. It is a 20 item survey. Responses are rated on a 5 point scale ranging from 1- ''can't do at all'' to 5- ''certain can do''. Item scores are summed to form a total score range 0-100 with higher scores indicating higher self-efficacy in performing diabetes self management activities.

    Measured: baseline, 3 months and 6 months

  8. Mean score Depressive symptoms using Patient Health Questionnaire-2 (PHQ-2)

    The PHQ-2 is a 2 item questionnaire used to assess the frequency of depressed mood. Item scores are summed with a total score ranging from 0 to 6 with higher scores indicating higher frequency of depressed moods.

    Measured: baseline, 3 months and 6 months

  9. Mean score Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)

    General Anxiety Disorder- 7 (GAD-7) is a 7 item self report instrument that measures anxiety. Items are scored on a 4-point scale, ranging from "not at all (0)" to "nearly everyday (3)". Item scores are summed with a total score ranging from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.

    Measured: baseline, 3 months and 6 months

  10. Mean score Family conflict using Diabetes Family Conflict Scale (DFCS)

    DFCS is a 19-item measure of diabetes management and the implications it has on the caregiver-child relationship. Items are scored on a 3-point Likert scale (1 = never argue, 2 = sometimes argue, and 3 = always argue). Item scores are summed with a total scale range of 19 to 57 with higher scores indicating a higher level of conflict.

    Measured: baseline, 3 months and 6 months

  11. Mean score Benefits and burdens of CGM use

    This survey consists of two sub-scales (one is benefits, one is burdens) with 8 items each. Each item scored Likert scale - Scored 1-5 Strongly Disagree to Agree. Items summed and divided by # of items. Mean score across participants. Each subscale range 1-5, with 5 indicating greater perceived benefits or burdens.

    Measured: baseline, 3 months and 6 months

  12. Mean Score Technology Attitudes

    5 items scored on a Likert scale, scored 1-5 (strongly disagree to agree). Items summed and divided by # of items. Mean score across participants. Score range 1-5, with 5 indicating more positive attitude about technology.

    Measured: baseline, 3 months and 6 months

  13. Mean score Glu-Coach satisfaction scale

    5 items scored on a Likert scale, scored 1-5 (not at all to extremely). Items summed and divided by # of items. Mean score across participants. Score range 1-5, with 5 indicating greater satisfaction.

    Measured: 3 months and 6 months

  14. Mean count Barriers to Device Use

    19 items with yes/no response. Mean number of barriers across participants. Higher value indicates more barriers.

    Measured: 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2023
  2. Study start21 May 2024
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06171412
Sponsor's protocol ID
2000033606
Other IDs
1R01DK134977-01
Acronym
Glu-COACH
Status last verified
Jul 2025
First submitted
5 Dec 2023
Last updated
17 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data associated with the study, upon request for qualified academic investigators for non-commercial use. Meta-analysis data along with data content, format, and organization, will be available on request. Submitted data will comply with relevant data and terminology standards. De-identified data will be made available upon request by the study principal investigators, and that these data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA). Names and Institutions of persons either given or denied access to the data, and the bases for such decisions, will be summarized in the annual progress report. Data and secondary analysis of data will be maintained in a secure data-base on the Yale system.

Questions about this trial

What is this clinical trial studying?

A study testing Glu-COACH in people with Type 1 Diabetes, run by Yale University 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 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: looking for participants now, as of the sponsor's last update on 17 Jul 2025. 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?

Contact Stuart A Weinzimer, MD (877.925.3637, stuart.weinzimer@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean hours per week CGM worn (time frame: 3 months and 6 months). 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 NCT06171412.

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 17 Jul 2025.

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