GO TEAM: Glucose Optimization Through Technology Assisted Management

Type 1 Diabetes Clinical Trial

Official title:

GO TEAM INTERVENTION PROTOCOL: GLUCOSE OPTIMIZATION THROUGH TECHNOLOGY ASSISTED MANAGEMENT: Use of a Diabetes Dashboard and Community Health Worker to Decrease Disparities in Technology Use in Pediatric T1D

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074458
• Other study ID #: Study20230860
• Secondary ID: 1R01DK134953
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: January 2024
• Source: Case Western Reserve University
• Contact: Sarah MacLeish, DO
• Phone: 216-844-3661
• Email: sarah.macleish2[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Glucosano
Glucosano is a remote patient monitoring diabetes dashboard with a patient facing Smartphone application

Behavioral:
• Community Health Worker diabetes technology coach
Community Health Workers will work with participants as a diabetes technology coach during scheduled and as needed visits

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Sarah MacLeish	KeborMed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in patient endorsement of intervention as measured by the Acceptability of Intervention Measure (AIM)	4 item measure of acceptability using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree	3 months and 12 months
Secondary	Change in patient endorsement of intervention as measured by Feasibility of Intervention Measure (FIM)	4 item measure of feasibility using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree	3 months and 12 months
Secondary	Change in patient endorsement of intervention as measured by Intervention Appropriateness Measure (IAM)	4 item measure of appropriateness using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree	3 months and 12 months
Secondary	Number of times patient reached out to team as measured by medical record review		Up to 12 months
Secondary	Number of automatically generated alerts as measured by dashboard/app review		Up to 12 months
Secondary	Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review		Up to 12 months
Secondary	Number of alerts as measured by dashboard review		Up to 12 months
Secondary	Number of phone calls initiated by patients as measured by dashboard review		Up to 12 months
Secondary	Number of downloads of the app		Up to 12 months
Secondary	Number of days of patient/family use interaction with the app as measured by dashboard review		Up to 12 months
Secondary	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
Secondary	Change in percentage of CGM wear time as measured by CGM data		Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	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
Secondary	Change in capillary HbA1c		Baseline, 3 months, 6 months, 9 months, 12 months
Secondary	Change in time in range as measured by continuous glucose monitoring	Time in range is time glucose is between 70-180 mg/dL	4 weeks, 6 months, 12 months
Secondary	Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring		4 weeks, 6 months, 12 months
Secondary	Change in time glucose >250 mg/dL as measured by continuous glucose monitoring		4 weeks, 6 months, 12 months
Secondary	Psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents	25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly true	Baseline
Secondary	Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale	19-item questionnaire using 3-point Likert scale, where 1 is almost never and 3 is almost always	4 weeks, 12 months
Secondary	Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy	28-item questionnaire using 5-point Likert scale, where 0 is almost never a problem and 4 is almost always a problem	4 weeks, 12 months
Secondary	Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version	18-item questionnaire using 5-point Likert scale, where 0 is agree and 4 is disagree	4 weeks, 12 months
Secondary	Change in medical distrust, as measured by the Group Based Medical Distrust Scale	12-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree	Baseline, 12 months
Secondary	Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index	7-item questionnaire regarding frequency of discrimination in healthcare ranging from never to 4 times or more in a lifetime	Baseline, 12 months
Secondary	Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index	4-item questionnaire using 5 point Likert scale where 1 is strongly disagree and 5 is strongly agree	Baseline, 12 months
Secondary	Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale	5-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree	Baseline, 12 months
Secondary	Change in barriers to technology as measured by Barriers to Technology Checklist	19-item yes/no questionnaire	Baseline, 12 months
Secondary	CGM satisfaction as measured by the CGM satisfaction scale	37-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree	12 months
Secondary	Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version	10-item questionnaire using 6-point Likert scale, where 1 is "very sure I can't" and 6 is "very sure I can"	4 weeks, 12 months
Secondary	Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale	16-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree	12 months
Secondary	Episodes of Diabetic Ketoacidosis as measured by chart review	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.	up to 12 months
Secondary	Episodes of severe hypoglycemia as measured by chart review	Unconscious or having a seizure due to hypoglycemia	up to 12 months