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GO TEAM: Glucose Optimization Through Technology Assisted Management

Primary Purpose

Type 1 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glucosano
Community Health Worker diabetes technology coach
Sponsored by
Sarah MacLeish
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 1 Diabetes focused on measuring Pediatric, Diabetes Technology, Disparities

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard of Care

Diabetes Dashboard and Community Health Worker

Arm Description

Participants in this arm follow standard of care procedures.

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.

Outcomes

Primary Outcome Measures

Change in percentage of participants who start on automated insulin delivery (AID) as measured by medical records review
Change in percentage of participants who remain on AID as measured by medical record review

Secondary Outcome Measures

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
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
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
Number of times patient reached out to team as measured by medical record review
Number of automatically generated alerts as measured by dashboard/app review
Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review
Number of alerts as measured by dashboard review
Number of phone calls initiated by patients as measured by dashboard review
Number of downloads of the app
Number of days of patient/family use interaction with the app as measured by dashboard review
Change in percentage of participants using continuous glucose monitor (CGM) with at least 80% wear time as measured by CGM data
Change in percentage of CGM wear time as measured by CGM data
Change in percentage of participants using an insulin pump as measured by chart review
Change in capillary HbA1c
Change in time in range as measured by continuous glucose monitoring
Time in range is time glucose is between 70-180 mg/dL
Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring
Change in time glucose >250 mg/dL as measured by continuous glucose monitoring
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
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
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
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
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
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
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
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
Change in barriers to technology as measured by Barriers to Technology Checklist
19-item yes/no questionnaire
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
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"
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
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.
Episodes of severe hypoglycemia as measured by chart review
Unconscious or having a seizure due to hypoglycemia

Full Information

First Posted
October 3, 2023
Last Updated
October 3, 2023
Sponsor
Sarah MacLeish
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), KeborMed
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1. Study Identification

Unique Protocol Identification Number
NCT06074458
Brief Title
GO TEAM: Glucose Optimization Through Technology Assisted Management
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2, 2024 (Anticipated)
Primary Completion Date
October 1, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah MacLeish
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), KeborMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Pediatric, Diabetes Technology, Disparities

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants in this arm follow standard of care procedures.
Arm Title
Diabetes Dashboard and Community Health Worker
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Glucosano
Intervention Description
Glucosano is a remote patient monitoring diabetes dashboard with a patient facing Smartphone application
Intervention Type
Behavioral
Intervention Name(s)
Community Health Worker diabetes technology coach
Intervention Description
Community Health Workers will work with participants as a diabetes technology coach during scheduled and as needed visits
Primary Outcome Measure Information:
Title
Change in percentage of participants who start on automated insulin delivery (AID) as measured by medical records review
Time Frame
Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Title
Change in percentage of participants who remain on AID as measured by medical record review
Time Frame
Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Secondary Outcome Measure Information:
Title
Change in patient endorsement of intervention as measured by the Acceptability of Intervention Measure (AIM)
Description
4 item measure of acceptability using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
Time Frame
3 months and 12 months
Title
Change in patient endorsement of intervention as measured by Feasibility of Intervention Measure (FIM)
Description
4 item measure of feasibility using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
Time Frame
3 months and 12 months
Title
Change in patient endorsement of intervention as measured by Intervention Appropriateness Measure (IAM)
Description
4 item measure of appropriateness using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
Time Frame
3 months and 12 months
Title
Number of times patient reached out to team as measured by medical record review
Time Frame
Up to 12 months
Title
Number of automatically generated alerts as measured by dashboard/app review
Time Frame
Up to 12 months
Title
Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review
Time Frame
Up to 12 months
Title
Number of alerts as measured by dashboard review
Time Frame
Up to 12 months
Title
Number of phone calls initiated by patients as measured by dashboard review
Time Frame
Up to 12 months
Title
Number of downloads of the app
Time Frame
Up to 12 months
Title
Number of days of patient/family use interaction with the app as measured by dashboard review
Time Frame
Up to 12 months
Title
Change in percentage of participants using continuous glucose monitor (CGM) with at least 80% wear time as measured by CGM data
Time Frame
Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Title
Change in percentage of CGM wear time as measured by CGM data
Time Frame
Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Title
Change in percentage of participants using an insulin pump as measured by chart review
Time Frame
Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Title
Change in capillary HbA1c
Time Frame
4 weeks, 3 months, 6 months, 9 months, 12 months
Title
Change in time in range as measured by continuous glucose monitoring
Description
Time in range is time glucose is between 70-180 mg/dL
Time Frame
4 weeks, 6 months, 12 months
Title
Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring
Time Frame
4 weeks, 6 months, 12 months
Title
Change in time glucose >250 mg/dL as measured by continuous glucose monitoring
Time Frame
4 weeks, 6 months, 12 months
Title
Psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents
Description
25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly true
Time Frame
Baseline
Title
Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale
Description
19-item questionnaire using 3-point Likert scale, where 1 is almost never and 3 is almost always
Time Frame
4 weeks, 12 months
Title
Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy
Description
28-item questionnaire using 5-point Likert scale, where 0 is almost never a problem and 4 is almost always a problem
Time Frame
4 weeks, 12 months
Title
Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version
Description
18-item questionnaire using 5-point Likert scale, where 0 is agree and 4 is disagree
Time Frame
4 weeks, 12 months
Title
Change in medical distrust, as measured by the Group Based Medical Distrust Scale
Description
12-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Time Frame
Baseline, 12 months
Title
Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index
Description
7-item questionnaire regarding frequency of discrimination in healthcare ranging from never to 4 times or more in a lifetime
Time Frame
Baseline, 12 months
Title
Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index
Description
4-item questionnaire using 5 point Likert scale where 1 is strongly disagree and 5 is strongly agree
Time Frame
Baseline, 12 months
Title
Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale
Description
5-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Time Frame
Baseline, 12 months
Title
Change in barriers to technology as measured by Barriers to Technology Checklist
Description
19-item yes/no questionnaire
Time Frame
Baseline, 12 months
Title
CGM satisfaction as measured by the CGM satisfaction scale
Description
37-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Time Frame
12 months
Title
Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version
Description
10-item questionnaire using 6-point Likert scale, where 1 is "very sure I can't" and 6 is "very sure I can"
Time Frame
4 weeks, 12 months
Title
Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale
Description
16-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Time Frame
12 months
Title
Episodes of Diabetic Ketoacidosis as measured by chart review
Description
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.
Time Frame
up to 12 months
Title
Episodes of severe hypoglycemia as measured by chart review
Description
Unconscious or having a seizure due to hypoglycemia
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah MacLeish, DO
Phone
216-844-3661
Email
sarah.macleish2@uhhospitals.org
First Name & Middle Initial & Last Name or Official Title & Degree
Paul McGuigan, RN, CDCES
Phone
216-844-7139
Email
paul.mcguigan@uhhospitals.org
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul McGuigan, RN, CDCES
Phone
216-844-7139
Email
paul.mcguigan@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Terri Casey, RN, CDCES
Phone
216-844-3627
Email
terri.casey@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Sarah A MacLeish, DO
First Name & Middle Initial & Last Name & Degree
Jamie R Wood, MD
First Name & Middle Initial & Last Name & Degree
Katherine Kutney, MD
First Name & Middle Initial & Last Name & Degree
Sarah Ronis, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rebecca Hazen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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GO TEAM: Glucose Optimization Through Technology Assisted Management

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