Type 1 DiabetesNCT06074458
GO TEAM: Glucose Optimization Through Technology Assisted Management
A study testing Glucosano and Community Health Worker diabetes technology coach in people with Type 1 Diabetes, run by Sarah MacLeish at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Glucosano and Community Health Worker diabetes technology coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 27 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
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
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Glucosano, Community Health Worker diabetes technology coach
- Keywords
- Pediatric, Diabetes Technology, Disparities
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucosanoOther
Glucosano is a remote patient monitoring diabetes dashboard with a patient facing Smartphone application
Community Health Worker diabetes technology coachBehavioural
Community Health Workers will work with participants as a diabetes technology coach during scheduled and as needed visits
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants in this arm follow standard of care procedures. |
| Diabetes Dashboard and Community Health Worker | Active comparator | 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. Receives: Other: Glucosano; Behavioral: Community Health Worker diabetes technology coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of participants who start on automated insulin delivery (AID) as measured by medical records review
Measured: 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
Measured: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Secondary outcomes (31)
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
Measured: 3 months and 12 months
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
Measured: 3 months and 12 months
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
Measured: 3 months and 12 months
Number of times patient reached out to team as measured by medical record review
Measured: Up to 12 months
Number of automatically generated alerts as measured by dashboard/app review
Measured: Up to 12 months
Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review
Measured: Up to 12 months
Number of alerts as measured by dashboard review
Measured: Up to 12 months
Number of phone calls initiated by patients as measured by dashboard review
Measured: Up to 12 months
Number of downloads of the app
Measured: Up to 12 months
Number of days of patient/family use interaction with the app as measured by dashboard review
Measured: Up to 12 months
Change in percentage of participants using continuous glucose monitor (CGM) with at least 80% wear time as measured by CGM data
Measured: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in percentage of CGM wear time as measured by CGM data
Measured: 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
Measured: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in capillary HbA1c
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in time in range as measured by continuous glucose monitoring
Time in range is time glucose is between 70-180 mg/dL
Measured: 4 weeks, 6 months, 12 months
Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring
Measured: 4 weeks, 6 months, 12 months
Change in time glucose >250 mg/dL as measured by continuous glucose monitoring
Measured: 4 weeks, 6 months, 12 months
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
Measured: Baseline
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
Measured: 4 weeks, 12 months
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
Measured: 4 weeks, 12 months
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
Measured: 4 weeks, 12 months
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
Measured: Baseline, 12 months
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
Measured: Baseline, 12 months
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
Measured: Baseline, 12 months
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
Measured: Baseline, 12 months
Change in barriers to technology as measured by Barriers to Technology Checklist
19-item yes/no questionnaire
Measured: Baseline, 12 months
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
Measured: 12 months
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"
Measured: 4 weeks, 12 months
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
Measured: 12 months
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.
Measured: up to 12 months
Episodes of severe hypoglycemia as measured by chart review
Unconscious or having a seizure due to hypoglycemia
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start29 Jan 2024
- Primary completion27 Jan 2027 (estimated)
- Study completion27 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah MacLeish
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), KeborMed
- Responsible party
- Sponsor-investigator, Sarah MacLeish, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074458
- Sponsor's protocol ID
- Study20230860
- Other IDs
- 1R01DK134953
- Status last verified
- Apr 2026
- First submitted
- 3 Oct 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06074458
- Acronym / sponsor ID
- Study20230860
- Conditions
- Type 1 Diabetes
- Keywords
- Pediatric, Diabetes Technology, Disparities
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sarah MacLeishUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), KeborMed
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 27 Jan 2027 (estimated)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants in this arm follow standard of care procedures. |
| Diabetes Dashboard and Community Health Worker | Active comparator | Other: Glucosano, Behavioral: Community Health Worker diabetes technology coachParticipants 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucosanoGlucosano is a remote patient monitoring diabetes dashboard with a patient facing Smartphone application | Other | Diabetes Dashboard and Community Health Worker |
| Community Health Worker diabetes technology coachCommunity Health Workers will work with participants as a diabetes technology coach during scheduled and as needed visits | Behavioural | Diabetes Dashboard and Community Health Worker |
Primary outcome
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
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
31 secondary outcomes
Change in patient endorsement of intervention as measured by the Acceptability of Intervention Measure (AIM)
Time frame: 3 months and 12 months
Change in patient endorsement of intervention as measured by Feasibility of Intervention Measure (FIM)
Time frame: 3 months and 12 months
Change in patient endorsement of intervention as measured by Intervention Appropriateness Measure (IAM)
Time frame: 3 months and 12 months
Number of times patient reached out to team as measured by medical record review
Time frame: Up to 12 months
Number of automatically generated alerts as measured by dashboard/app review
Time frame: Up to 12 months
Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review
Time frame: Up to 12 months
Number of alerts as measured by dashboard review
Time frame: Up to 12 months
Number of phone calls initiated by patients as measured by dashboard review
Time frame: Up to 12 months
Number of downloads of the app
Time frame: Up to 12 months
Number of days of patient/family use interaction with the app as measured by dashboard review
Time frame: Up to 12 months
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
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
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
Change in capillary HbA1c
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in time in range as measured by continuous glucose monitoring
Time frame: 4 weeks, 6 months, 12 months
Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring
Time frame: 4 weeks, 6 months, 12 months
Change in time glucose >250 mg/dL as measured by continuous glucose monitoring
Time frame: 4 weeks, 6 months, 12 months
Psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents
Time frame: Baseline
Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale
Time frame: 4 weeks, 12 months
Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy
Time frame: 4 weeks, 12 months
Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version
Time frame: 4 weeks, 12 months
Change in medical distrust, as measured by the Group Based Medical Distrust Scale
Time frame: Baseline, 12 months
Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index
Time frame: Baseline, 12 months
Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index
Time frame: Baseline, 12 months
Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale
Time frame: Baseline, 12 months
Change in barriers to technology as measured by Barriers to Technology Checklist
Time frame: Baseline, 12 months
CGM satisfaction as measured by the CGM satisfaction scale
Time frame: 12 months
Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version
Time frame: 4 weeks, 12 months
Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale
Time frame: 12 months
Episodes of Diabetic Ketoacidosis as measured by chart review
Time frame: up to 12 months
Episodes of severe hypoglycemia as measured by chart review
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucosano and Community Health Worker diabetes technology coach in people with Type 1 Diabetes, run by Sarah MacLeish at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.