Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05849753 |
| Other study ID # |
1980589-3] |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 26, 2023 |
| Est. completion date |
May 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Nemours Children's Clinic |
| Contact |
Nelly Mauras, MD |
| Phone |
904-697-3674 |
| Email |
Nelly.Mauras[@]nemours.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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:
1. 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;
2. can any clinical benefit be sustained for 6 months in a real life setting;
3. can the above treatments improve patient/family reported perceptions of quality of life,
including diabetes distress and psychosocial aspects of closed-loop technology?
(secondary)
