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NCT Number: NCT06171412

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Children's Diabetes Clinic

New Haven, Connecticut, 06520, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Glu-COACH

Behavioral

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

Primary outcomes

  1. Mean hours per week CGM worn

    Time frame: 3 months and 6 months

    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.

Secondary outcomes

  1. CGM Mean glucose

    Time frame: baseline, 3 months and 6 months

    The mean glucose in mg/dL

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

    Time frame: baseline, 3 months and 6 months

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

  3. Mean A1C concentration

    Time frame: baseline, 3 months and 6 months

    Mean A1C concentration

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

    Time frame: baseline, 3 months and 6 months

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

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

    Time frame: baseline, 3 months and 6 months

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

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

    Time frame: baseline, 3 months and 6 months

    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.

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

    Time frame: baseline, 3 months and 6 months

    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.

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

    Time frame: baseline, 3 months and 6 months

    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.

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

    Time frame: baseline, 3 months and 6 months

    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.

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

    Time frame: baseline, 3 months and 6 months

    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.

  11. Mean score Benefits and burdens of CGM use

    Time frame: baseline, 3 months and 6 months

    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.

  12. Mean Score Technology Attitudes

    Time frame: baseline, 3 months and 6 months

    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.

  13. Mean score Glu-Coach satisfaction scale

    Time frame: 3 months and 6 months

    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.

  14. Mean count Barriers to Device Use

    Time frame: 3 months and 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Robin Whittemore, PhD, APRN, FAAN

CONTACT

[email protected]

203-737-2351

Stuart A Weinzimer, MD

CONTACT

[email protected]

877.925.3637

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: Glu-COACH

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 14, 2023
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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