Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT05849753 |
Recruitment Status :
Recruiting
First Posted : May 9, 2023
Last Update Posted : May 9, 2023
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Condition or disease | Intervention/treatment |
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Diabetes Mellitus, Type 1 Child Delivery of Health Care Equipment and Supplies | Device: Advanced artificial pancreas closed-loop technology |
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 Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Breaking Health Care Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes |
Estimated Study Start Date : | May 15, 2023 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |
Group/Cohort | Intervention/treatment |
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T1DM lower SES
Type 1 diabetes of lower SES, including AA and Latino racial/ethnic minorities, who are in suboptimal diabetes control.
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Device: Advanced artificial pancreas closed-loop technology
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). |
- Percent sensor glucose time-in-range [ Time Frame: 3 months ]70-180mg/dL
- HbA1C [ Time Frame: 3 months ]percent
- Percent sensor glucose time in hypoglycemic range [ Time Frame: 3 months ]less than 54 mg/dL
- Perceptions of Benefits & Burden of Closed-Loop Systems [ Time Frame: 3 months ]Psychosocial questionnaire (Scale: 35-175); higher score reflects better outcome
- Problem Areas in Diabetes [ Time Frame: 3 months ]Psychosocial questionnaire (Scale: 0-80); lower score reflects better outcome
- Technology Attitudes [ Time Frame: 3 months ]Psychosocial questionnaire related to diabetes technology (Scale: 5-25); higher score reflects better outcome
- Percent sensor glucose time-in-range [ Time Frame: 6 months ]70-180mg/dL
- HbA1C [ Time Frame: 6 months ]percent
- Percent sensor glucose time in hypoglycemic range [ Time Frame: 6 months ]less than 54 mg/dL
- Perceptions of Benefits & Burden of Closed-Loop Systems [ Time Frame: 6 months ]Psychosocial questionnaire (Scale: 35-175); higher score reflects better outcome
- Problem Areas in Diabetes [ Time Frame: 6 months ]Psychosocial questionnaire (Scale: 0-80); lower score reflects better outcome
- Technology Attitudes [ Time Frame: 6 months ]Psychosocial questionnaire relating to diabetes technology (Scale: 5-25); higher score reflects better outcome
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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05849753
Contact: Nelly Mauras, MD | 904-697-3674 | Nelly.Mauras@nemours.org | |
Contact: Kelly Hildebrandt, MD | 904-697-3674 | kelly.hildebrandt@nemours.org |
United States, Florida | |
Nemours Children's Health | Recruiting |
Jacksonville, Florida, United States, 32207 | |
Contact: Nelly Mauras, MD 904-697-3674 nmauras@nemours.org | |
Contact: Kelly Hildebrandt, MD 904-314-7276 kelly.hilldebrandt@nemours.org | |
Principal Investigator: Nelly Mauras, M.D | |
Nemours Children's Health | Not yet recruiting |
Orlando, Florida, United States, 32827 | |
Contact: Mauri Carakushansky, MD 407-650-7144 mauri.carakusansky@neours.org | |
Contact: Kelly Hilldebrandt, MD 904-314-7276 kelly.hildebrandt@nemours.org |
Principal Investigator: | Nelly Mauras, MD | Nemours Children's Health Jacksonville |
Responsible Party: | Nelly Mauras, Vice Chair of Pediatrics for Research/Director of Research, Nemours North FL, Nemours Children's Clinic |
ClinicalTrials.gov Identifier: | NCT05849753 |
Other Study ID Numbers: |
1980589-3] |
First Posted: | May 9, 2023 Key Record Dates |
Last Update Posted: | May 9, 2023 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Pancrelipase Gastrointestinal Agents |