Status:
COMPLETED
Hybrid Closed Loop in High Risk Youth With Type 1 Diabetes
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
Tandem Diabetes Care, Inc.
DexCom, Inc.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
6-21 years
Phase:
NA
Brief Summary
The use of insulin pumps and continuous glucose monitors for Type 1 diabetes (T1D) has been shown to improve glycemic control while also decreasing the risk for acute and chronic complications. Unfort...
Detailed Description
T1D is among the most common chronic childhood illness, affecting an estimated 1 in 400 American children.2 The care of children and adolescents with type 1 diabetes aims to optimize glycemic control ...
Eligibility Criteria
Inclusion
- Patients clinically diagnosed with T1D managed with insulin for at least 1 year
- Black race
- Public healthcare insurance
- Male or female ages ≥ 6 and \< 21 years
- Not currently using insulin pump therapy
- Poorly controlled T1D: one A1c value ≥ 10% in the preceding two years and a second A1c value ≥ 10% at enrollment
- Investigators and primary clinical endocrine clinician have confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
- Living with one or more parent/legal guardian/ friend (for adults only) knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
- Total daily insulin dose of at least 10 units per day based on FDA approval for Control IQ
- For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential at study entry and can be repeated as necessary in case of clinical concern. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Not currently using and willingness not to start any non-insulin glucose-lowering agent during the course of the trial
- Fluent in English as the Control IQ technology is currently available only in English
- Willing to adhere to the study regimen
Exclusion
- Concurrent use of any non-insulin diabetes medications
- More than 3 episodes of DKA in the year prior to enrollment
- Major illnesses other than T1D
- Significant cognitive limitations and major psychiatric disorders
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Having immediate family members employed by Tandem Diabetes Care, Inc., TypeZero Technologies, LLC, Dexcom, Inc. or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04807374
Start Date
June 1 2021
End Date
June 22 2023
Last Update
August 29 2023
Active Locations (1)
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1
Children's National
Washington D.C., District of Columbia, United States, 20010