Diabetes Mellitus, Type 1NCT05849753
Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1 and Child, run by Nemours Children's Clinic at 2 sites in United States.
Trial summary
50 children/adolescents (ages 6 to <18yrs) with T1D in suboptimal control (HbA1c≥8.0%) and lower SES (below 200% poverty line) on insulin therapy (either injections or open-loop pumps) will be recruited at Nemours ~ 1/3 each AA, Hispanic/Latino, non-Hispanic whites. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Child, Delivery of Health Care
- What is being tested?
- Advanced artificial pancreas closed-loop technology
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jul 2023to 31 Dec 2026
- Phase
- Observational
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: A target of 50 children and adolescents (ages 6 to <18yrs) with T1D in suboptimal control (HbA1c≥8.0%) and of lower SES (below 200% of state-specific poverty line by family size and income), with no other chronic illnesses will be recruited from the Pediatric Endocrine clinics at Nemours Children's Health Clinics in Jacksonville and Orlando, FL. Cohort will be ~ 1/3 each AA, Hispanic/Latino, and non-Hispanic White (NHW).
Who may be able to join
- Diagnosis of T1D for at least 1 year based on clinical presentation (polyuria, polydipsia, weight loss, and/or ketoacidosis, or with positive diabetes autoantibodies) on insulin, including injections or open-loop pumps
- HbA1C ≥ 8.0% at least twice within the last 12 months before study initiation, upper limit of HbA1C <14%
- Be of lower SES, defined based on < 200% above published US levels of poverty by family size and income, or based on exceptional circumstantial needs in the opinion of the investigators
- Approximately 1/3 AA, 1/3 Hispanic/Latinos, 1/3 non-Hispanic whites. Asians, Pacific Islanders and other ethnic groups however will not be excluded from participation if other criteria met
- History of hypothyroidism on adequate replacement therapy with normal thyroid function will be allowed
Who cannot join
- Severe eczema or any other skin condition that would limit availability of healthy skin to wear devices
- Chronic medications/medical conditions that could interfere with diabetes management (ADHD medications allowed)
- Chronic seizures, or severe neurodevelopmental delay
- Current use of hybrid closed-loop, automated insulin delivery system
- Significant mental health disorder that in opinion of the investigator would hinder device use
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Nemours Children's Health
Jacksonville, Florida, 32207
Nelly Mauras, MD, 904-697-3674, nmauras@nemours.org
Kelly Hildebrandt, MD, 904-314-7276, kelly.hilldebrandt@nemours.org
- Not yet recruiting
Nemours Children's Health
Orlando, Florida, 32827
Mauri Carakushansky, MD, 407-650-7144, mauri.carakusansky@neours.org
Kelly Hilldebrandt, MD, 904-314-7276, kelly.hildebrandt@nemours.org
About this study
Official title: Breaking Health Care Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
50 children/adolescents (ages 6 to <18yrs) with T1D in suboptimal control (HbA1c≥8.0%) and lower SES (below 200% poverty line) on insulin therapy (either injections or open-loop pumps) will be recruited at Nemours ~ 1/3 each AA, Hispanic/Latino, non-Hispanic whites. All families that qualify and agree to transition to closed-loop technologies will be recruited to allow data to be gathered before and after use of devices. They will go through the process of approval with the assistance of an insurance navigator in clinic. Those not a CGM will be prescribed one as well. Diabetes care will be 'real life', devices will be prescribed, and care per clinic routine with periodic device downloads. Principal outcome, time-in-range, will be analyzed at 3-months compared to baseline, each participant their own control. Secondary outcomes including HbA1c, other glucose metrics and questionnaires related to use of technology and diabetes distress will be also analyzed. All outcomes will also be collected at 6-months. Results could have important and fast applicability to the field and help better inform decision makers, including payers, clinicians, and patients and families and could serve to decrease health care disparities in this needy population.
Read the detailed description
Type 1 diabetes (T1D) has serious complications, yet only ~17% of children achieve an HbA1C goal of <7.5% and in adolescents mean HbA1c remains persistently high at 9.3%. Technology use in children has increased, both insulin pump use and continuous glucose monitors (CGM), offering hope to improve diabetes control and outcomes. There are however, striking socio-economic (SES) and racial/ethnic disparities in these outcomes, with worse metabolic control and much lower use of technology in those of lower SES and racial/ethnic minorities. Reasons are multifactorial, including more limited access to care, insurance challenges, and providers' biases in prescribing these devices, but also related to implicit bias and structural racism towards minority groups. Rates of diabetes complications and ketoacidosis are higher in Black and Latino youth, yet these children are largely under-represented in clinical trials and in the clinical use of FDA-approved modern diabetes technologies. Closed-loop artificial pancreas now allows for the semi-automatic or fully automatic delivery of insulin based on CGM glucose, with potential to further improve glycemic control. The investigators' recent data suggest that patients in ethnic minority groups provided devices through a clinical trial may indeed benefit from this technology with improved time-in-range and HbA1c. Insurance companies, including Medicaid now include these FDA-approved devices in their formulary, yet they continue to be underutilized by these needy families. The investigators believe the overwhelming amount of data support the routine use of closed-loop insulin delivery technology in children. The proposed study will be first to compare use of advanced closed-loop insulin delivery systems specifically focused on children with T1D of lower SES, including racial/ethnic minorities, using patient-centered outcomes while understanding clinical markers of diabetic control. The principal study question is whether these children can benefit from a closed-loop insulin delivery treatment option and improve health care disparities in a 'real life' setting.
Specific Aims:
To investigate in children with type 1 diabetes of lower SES, including AA and Latino racial/ethnic minorities, who are in suboptimal diabetes control, if when they are consistently offered advanced artificial pancreas closed-loop technology, and are better assisted in getting approval and starting these devices clinically:
- can health care disparities decrease by improving overall diabetes control including time-in-range sensor glucose(70-180mg/dl) (principal) and other metrics of glycemic control including HbA1c at 3 months;
- can any clinical benefit be sustained for 6 months in a real life setting;
- can the above treatments improve patient/family reported perceptions of quality of life, including diabetes distress and psychosocial aspects of closed-loop technology? (secondary)
- Being tested
- Advanced artificial pancreas closed-loop technology
- 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.
Advanced artificial pancreas closed-loop technologyDevice
Study is an observational capture of data in patients that qualify, before and after the use of any FDA-approved closed-loop system of Subject's/Family's choosing that uses a CGM that does not require fingerprick calibrations. Devices prescribed available through their insurance (including Medicaid).
| Study group | Role | What they receive |
|---|---|---|
| T1DM lower SES | Type 1 diabetes of lower SES, including AA and Latino racial/ethnic minorities, who are in suboptimal diabetes control. Receives: Device: Advanced artificial pancreas closed-loop technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent sensor glucose time-in-range
70-180mg/dL
Measured: 3 months
Secondary outcomes (11)
HbA1C
percent
Measured: 3 months
Percent sensor glucose time in hypoglycemic range
less than 54 mg/dL
Measured: 3 months
Perceptions of Benefits & Burden of Closed-Loop Systems
Psychosocial questionnaire (Scale: 35-175); higher score reflects better outcome
Measured: 3 months
Problem Areas in Diabetes
Psychosocial questionnaire (Scale: 0-80); lower score reflects better outcome
Measured: 3 months
Technology Attitudes
Psychosocial questionnaire related to diabetes technology (Scale: 5-25); higher score reflects better outcome
Measured: 3 months
Percent sensor glucose time-in-range
70-180mg/dL
Measured: 6 months
HbA1C
percent
Measured: 6 months
Percent sensor glucose time in hypoglycemic range
less than 54 mg/dL
Measured: 6 months
Perceptions of Benefits & Burden of Closed-Loop Systems
Psychosocial questionnaire (Scale: 35-175); higher score reflects better outcome
Measured: 6 months
Problem Areas in Diabetes
Psychosocial questionnaire (Scale: 0-80); lower score reflects better outcome
Measured: 6 months
Technology Attitudes
Psychosocial questionnaire relating to diabetes technology (Scale: 5-25); higher score reflects better outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start26 Jul 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Principal investigator, Nelly Mauras, Nemours Children's Clinic
- Investigators
- Nelly Mauras, MD, Principal investigator, Nemours Children's Health Jacksonville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849753
- Sponsor's protocol ID
- 1980589-3]
- Status last verified
- Feb 2026
- First submitted
- 26 Mar 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking Health Care Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05849753
- Acronym / sponsor ID
- 1980589-3]
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Jaeb Center for Health Research
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 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.
50 children/adolescents (ages 6 to <18yrs) with T1D in suboptimal control (HbA1c≥8.0%) and lower SES (below 200% poverty line) on insulin therapy (either injections or open-loop pumps) will be recruited at Nemours ~ 1/3 each AA, Hispanic/Latino, non-Hispanic whites. All families that qualify and agree to transition to closed-loop technologies will be recruited to allow data to be gathered before and after use of devices. They will go through the process of approval with the assistance of an insurance navigator in clinic. Those not a CGM will be prescribed one as well. Diabetes care will be 'real life', devices will be prescribed, and care per clinic routine with periodic device downloads. Principal outcome, time-in-range, will be analyzed at 3-months compared to baseline, each participant their own control. Secondary outcomes including HbA1c, other glucose metrics and questionnaires related to use of technology and diabetes distress will be also analyzed. All outcomes will also be collected at 6-months. Results could have important and fast applicability to the field and help better inform decision makers, including payers, clinicians, and patients and families and could serve to decrease health care disparities in this needy population.
Detailed description
Type 1 diabetes (T1D) has serious complications, yet only ~17% of children achieve an HbA1C goal of <7.5% and in adolescents mean HbA1c remains persistently high at 9.3%. Technology use in children has increased, both insulin pump use and continuous glucose monitors (CGM), offering hope to improve diabetes control and outcomes. There are however, striking socio-economic (SES) and racial/ethnic disparities in these outcomes, with worse metabolic control and much lower use of technology in those of lower SES and racial/ethnic minorities. Reasons are multifactorial, including more limited access to care, insurance challenges, and providers' biases in prescribing these devices, but also related to implicit bias and structural racism towards minority groups. Rates of diabetes complications and ketoacidosis are higher in Black and Latino youth, yet these children are largely under-represented in clinical trials and in the clinical use of FDA-approved modern diabetes technologies. Closed-loop artificial pancreas now allows for the semi-automatic or fully automatic delivery of insulin based on CGM glucose, with potential to further improve glycemic control. The investigators' recent data suggest that patients in ethnic minority groups provided devices through a clinical trial may indeed benefit from this technology with improved time-in-range and HbA1c. Insurance companies, including Medicaid now include these FDA-approved devices in their formulary, yet they continue to be underutilized by these needy families. The investigators believe the overwhelming amount of data support the routine use of closed-loop insulin delivery technology in children. The proposed study will be first to compare use of advanced closed-loop insulin delivery systems specifically focused on children with T1D of lower SES, including racial/ethnic minorities, using patient-centered outcomes while understanding clinical markers of diabetic control. The principal study question is whether these children can benefit from a closed-loop insulin delivery treatment option and improve health care disparities in a 'real life' setting.
Specific Aims:
To investigate in children with type 1 diabetes of lower SES, including AA and Latino racial/ethnic minorities, who are in suboptimal diabetes control, if when they are consistently offered advanced artificial pancreas closed-loop technology, and are better assisted in getting approval and starting these devices clinically:
- can health care disparities decrease by improving overall diabetes control including time-in-range sensor glucose(70-180mg/dl) (principal) and other metrics of glycemic control including HbA1c at 3 months;
- can any clinical benefit be sustained for 6 months in a real life setting;
- can the above treatments improve patient/family reported perceptions of quality of life, including diabetes distress and psychosocial aspects of closed-loop technology? (secondary)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T1DM lower SES | – | Device: Advanced artificial pancreas closed-loop technologyType 1 diabetes of lower SES, including AA and Latino racial/ethnic minorities, who are in suboptimal diabetes control. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A target of 50 children and adolescents (ages 6 to <18yrs) with T1D in suboptimal control (HbA1c≥8.0%) and of lower SES (below 200% of state-specific poverty line by family size and income), with no other chronic illnesses will be recruited from the Pediatric Endocrine clinics at Nemours Children's Health Clinics in Jacksonville and Orlando, FL. Cohort will be ~ 1/3 each AA, Hispanic/Latino, and non-Hispanic White (NHW).
Key inclusion criteria (5 listed)
- Diagnosis of T1D for at least 1 year based on clinical presentation (polyuria, polydipsia, weight loss, and/or ketoacidosis, or with positive diabetes autoantibodies) on insulin, including injections or open-loop pumps
- HbA1C ≥ 8.0% at least twice within the last 12 months before study initiation, upper limit of HbA1C <14%
- Be of lower SES, defined based on < 200% above published US levels of poverty by family size and income, or based on exceptional circumstantial needs in the opinion of the investigators
- Approximately 1/3 AA, 1/3 Hispanic/Latinos, 1/3 non-Hispanic whites. Asians, Pacific Islanders and other ethnic groups however will not be excluded from participation if other criteria met
- History of hypothyroidism on adequate replacement therapy with normal thyroid function will be allowed
Key exclusion criteria (5 listed)
- Severe eczema or any other skin condition that would limit availability of healthy skin to wear devices
- Chronic medications/medical conditions that could interfere with diabetes management (ADHD medications allowed)
- Chronic seizures, or severe neurodevelopmental delay
- Current use of hybrid closed-loop, automated insulin delivery system
- Significant mental health disorder that in opinion of the investigator would hinder device use
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 |
|---|---|---|
| Advanced artificial pancreas closed-loop technologyStudy is an observational capture of data in patients that qualify, before and after the use of any FDA-approved closed-loop system of Subject's/Family's choosing that uses a CGM that does not require fingerprick calibrations. Devices prescribed available through their insurance (including Medicaid). | Device | T1DM lower SES |
Primary outcome
Percent sensor glucose time-in-range
Time frame: 3 months
70-180mg/dL
11 secondary outcomes
HbA1C
Time frame: 3 months
Percent sensor glucose time in hypoglycemic range
Time frame: 3 months
Perceptions of Benefits & Burden of Closed-Loop Systems
Time frame: 3 months
Problem Areas in Diabetes
Time frame: 3 months
Technology Attitudes
Time frame: 3 months
Percent sensor glucose time-in-range
Time frame: 6 months
HbA1C
Time frame: 6 months
Percent sensor glucose time in hypoglycemic range
Time frame: 6 months
Perceptions of Benefits & Burden of Closed-Loop Systems
Time frame: 6 months
Problem Areas in Diabetes
Time frame: 6 months
Technology Attitudes
Time frame: 6 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 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Nelly Mauras, MD principal investigator
Nemours Children's Health Jacksonville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Child, run by Nemours Children's Clinic at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Nelly Mauras, MD (904-697-3674, Nelly.Mauras@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent sensor glucose time-in-range (time frame: 3 months). 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 20 Jul 2026.