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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
38
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
Yale Children's Diabetes Clinic
New Haven, Connecticut, United States
RECRUITINGMean 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.
Time frame: 3 months and 6 months
CGM Mean glucose
The mean glucose in mg/dL
Time frame: 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
Time frame: baseline, 3 months and 6 months
Mean A1C concentration
Mean A1C concentration
Time frame: 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
Time frame: 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
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months and 6 months