Type 1 Diabetes
Conditions
Keywords
continuous glucose monitor
Brief 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. 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.
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.
Interventions
BEHAVIORALGlu-COACH
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
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean hours per week CGM worn | 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
| Measure | Time frame | Description |
|---|---|---|
| CGM Mean glucose | baseline, 3 months and 6 months | The mean glucose in mg/dL |
| CGM Percentage time in range (70-180mg/dL) | baseline, 3 months and 6 months | Percentage of time participants glucose values are in the target range of 70-180 mg/dL |
| Number of Adverse diabetes-related events (diabetic ketoacidosis) | baseline, 3 months and 6 months | Number of Yes/no responses via self report of diabetic ketoacidosis |
| Number of Adverse diabetes-related events (severe hypoglycemia) | baseline, 3 months and 6 months | Number of Yes/no responses via self report of severe hypoglycemia |
| Mean score in Diabetes Distress using Problem Areas in Diabetes-Teen (PAID-T) survey | 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. |
| Mean score Diabetes self-efficacy using Diabetes Management Self-Efficacy scale (DMSES) | 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. |
| Mean A1C concentration | baseline, 3 months and 6 months | Mean A1C concentration |
| Mean score Anxiety symptoms using General Anxiety Disorder-7 (GAD-7) | 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. |
| Mean score Family conflict using Diabetes Family Conflict Scale (DFCS) | 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. |
| Mean score Benefits and burdens of CGM use | 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. |
| Mean Score Technology Attitudes | 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. |
| Mean score Glu-Coach satisfaction scale | 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. |
| Mean count Barriers to Device Use | 3 months and 6 months | 19 items with yes/no response. Mean number of barriers across participants. Higher value indicates more barriers. |
| Mean score Depressive symptoms using Patient Health Questionnaire-2 (PHQ-2) | 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. |
Countries
United States
Contacts
Primary ContactStuart A Weinzimer, MD
Backup ContactRobin Whittemore, PhD, APRN, FAAN
Outcome results
None listed