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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK134977-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glu-COACH | Experimental | The 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Mean glucose | The mean glucose in mg/dL | baseline, 3 months and 6 months |
| CGM Percentage time in range (70-180mg/dL) | Percentage of time participants glucose values are in the target range of 70-180 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Robin Whittemore, PhD, APRN, FAAN | Yale School of Nursing | Principal Investigator |
| Stuart A Weinzimer, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Children's Diabetes Clinic | Recruiting | New Haven | Connecticut | 06520 | United States |
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.
After completion of the funded project period for the parent award and upon acceptance of the data for publication.
Investigators agree to identify where the data will be available and how to access the data in any publications and presentations that the investigators author or co-author about these data, as well as acknowledge the funding source in any publications and presentations.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| baseline, 3 months and 6 months |
| Mean A1C concentration | Mean A1C concentration | baseline, 3 months and 6 months |
| Number of Adverse diabetes-related events (diabetic ketoacidosis) | Number of Yes/no responses via self report of diabetic ketoacidosis | baseline, 3 months and 6 months |
| Number of Adverse diabetes-related events (severe hypoglycemia) | Number of Yes/no responses via self report of severe hypoglycemia | baseline, 3 months and 6 months |
| 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. | baseline, 3 months and 6 months |
| 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. | baseline, 3 months and 6 months |
| 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. | baseline, 3 months and 6 months |
| 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. | baseline, 3 months and 6 months |
| 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. | baseline, 3 months and 6 months |
| 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. | baseline, 3 months and 6 months |
| 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. | baseline, 3 months and 6 months |
| 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. | 3 months and 6 months |
| Mean count Barriers to Device Use | 19 items with yes/no response. Mean number of barriers across participants. Higher value indicates more barriers. | 3 months and 6 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |