GO TEAM: Glucose Optimization Through Technology Assisted Management
- Conditions
- Type 1 Diabetes
- Interventions
- Other: GlucosanoBehavioral: Community Health Worker diabetes technology coach
- Registration Number
- NCT06074458
- Lead Sponsor
- Sarah MacLeish
- Brief Summary
Black/African American children and young adults with type 1 diabetes are less likely to use diabetes technologies, such as continuous glucose monitors, insulin pumps, and automated insulin delivery systems, compared to White children and young adults. The investigators are working to find ways to make sure that all patients with type 1 diabetes are equally able to use these technologies. The purpose of this study is to find out if a new computer program for the diabetes team, along with a smartphone app (called Glucosano) for patients/parents, as well as a community health worker, are accepted and used by Black/African American patients and parents living with type 1 diabetes, and if this can help decrease racial disparities in the use of diabetes technologies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Self-reported as Non-Hispanic Black
- Clinical diagnosis of T1D requiring treatment with insulin at the time of consent
- Not currently (within the past 3 months) using an automated insulin delivery system \
- Willingness to wear a continuous glucose monitor for 10 days at 3 different time points, and willingness to consider use of a personal continuous glucose monitor
- Clinical diagnosis of Type 2 or monogenic diabetes
- Completed high school
- Non-English speaking guardians
- Automated insulin delivery system use within the past 3 months
- Custody of children and family services
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diabetes Dashboard and Community Health Worker Glucosano Participants diabetes technology devices will be linked to a remote patient monitoring dashboard and will have access to a Smartphone application, as well as scheduled and as needed visits with a community health worker. Diabetes Dashboard and Community Health Worker Community Health Worker diabetes technology coach Participants diabetes technology devices will be linked to a remote patient monitoring dashboard and will have access to a Smartphone application, as well as scheduled and as needed visits with a community health worker.
- Primary Outcome Measures
Name Time Method Change in percentage of participants who start on automated insulin delivery (AID) as measured by medical records review Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months Change in percentage of participants who remain on AID as measured by medical record review Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
- Secondary Outcome Measures
Name Time Method Change in patient endorsement of intervention as measured by the Acceptability of Intervention Measure (AIM) 3 months and 12 months 4 item measure of acceptability using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
Number of times patient reached out to team as measured by medical record review Up to 12 months Number of alerts as measured by dashboard review Up to 12 months Number of phone calls initiated by patients as measured by dashboard review Up to 12 months Change in patient endorsement of intervention as measured by Feasibility of Intervention Measure (FIM) 3 months and 12 months 4 item measure of feasibility using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
Change in patient endorsement of intervention as measured by Intervention Appropriateness Measure (IAM) 3 months and 12 months 4 item measure of appropriateness using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
Number of automatically generated alerts as measured by dashboard/app review Up to 12 months Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review Up to 12 months Number of downloads of the app Up to 12 months Number of days of patient/family use interaction with the app as measured by dashboard review Up to 12 months Change in time in range as measured by continuous glucose monitoring 4 weeks, 6 months, 12 months Time in range is time glucose is between 70-180 mg/dL
Change in percentage of participants using continuous glucose monitor (CGM) with at least 80% wear time as measured by CGM data Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months Change in percentage of CGM wear time as measured by CGM data Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months Change in percentage of participants using an insulin pump as measured by chart review Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months Change in barriers to technology as measured by Barriers to Technology Checklist Baseline, 12 months 19-item yes/no questionnaire
CGM satisfaction as measured by the CGM satisfaction scale 12 months 37-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version 4 weeks, 12 months 10-item questionnaire using 6-point Likert scale, where 1 is "very sure I can't" and 6 is "very sure I can"
Episodes of Diabetic Ketoacidosis as measured by chart review up to 12 months DKA defined as presence of all of the following: 1) blood glucose greater than 250 mg/dL, 2) pH less than 7.3 OR bicarbonate less 15 mEq/L, 3)Moderate or large ketones in urine OR blood ketone \>3 mmol/L, 4) Requiring treatment within a health care facility.
Change in capillary HbA1c Baseline, 3 months, 6 months, 9 months, 12 months Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring 4 weeks, 6 months, 12 months Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale 4 weeks, 12 months 19-item questionnaire using 3-point Likert scale, where 1 is almost never and 3 is almost always
Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version 4 weeks, 12 months 18-item questionnaire using 5-point Likert scale, where 0 is agree and 4 is disagree
Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy 4 weeks, 12 months 28-item questionnaire using 5-point Likert scale, where 0 is almost never a problem and 4 is almost always a problem
Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index Baseline, 12 months 7-item questionnaire regarding frequency of discrimination in healthcare ranging from never to 4 times or more in a lifetime
Change in time glucose >250 mg/dL as measured by continuous glucose monitoring 4 weeks, 6 months, 12 months Psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents Baseline 25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly true
Change in medical distrust, as measured by the Group Based Medical Distrust Scale Baseline, 12 months 12-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index Baseline, 12 months 4-item questionnaire using 5 point Likert scale where 1 is strongly disagree and 5 is strongly agree
Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale Baseline, 12 months 5-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale 12 months 16-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Episodes of severe hypoglycemia as measured by chart review up to 12 months Unconscious or having a seizure due to hypoglycemia
Trial Locations
- Locations (1)
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States