Status:
COMPLETED
Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents w...
Detailed Description
This is a single center, double-blind, randomized, crossover trial. The study team will target enrollment of 30 adolescents (age 12 - \<18 years) with T1D who currently manage their diabetes with an i...
Eligibility Criteria
Inclusion
- Age ≥12 and \<18 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of T1D for at least one year
- Currently using insulin for at least six months
- Currently using an insulin pump for at least three months
- Currently using a CGM system for at least three months
- Having at least 75% of CGM data over the previous four weeks
- Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
- Access to internet and willingness to upload data during the study as needed
- For females, not currently known to be pregnant or breastfeeding
- A negative urine pregnancy test will be required for all females of childbearing potential
- Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- Total daily insulin dose (TDD) of at least 10 U/day
- Willingness not to start any non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- Willingness to eat at least 40 grams of carbohydrates per meal
- An understanding and willingness to follow the protocol and signed informed consent
- Participants and parent/legal guardians will be proficient in reading and writing in English
- Willingness to comply with COVID-19 precautions as defined by the study team
- Having completed a COVID-19 vaccination with an FDA-approved COVID-19 vaccine at least two weeks before the first study admission, and willing to provide a copy of the COVID-19 vaccination card
Exclusion
- Hemoglobin A1c \<5% or \>10% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid HbA1c measurement, average blood glucose estimated from CGM data to be approximately between 100 and 240 mg/dL
- History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently breastfeeding or planning to breastfeed
- Currently being treated for a seizure disorder
- Planned surgery during study duration
- History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
- Treatment with any non-insulin glucose-lowering agent (metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Use of an insulin delivery mechanism that is not downloadable by the participant or study team
- Known contact with COVID-positive individual within 14 days of any study admission without negative follow-up COVID-19 Polymerase Chain Reaction (PCR) test performed 3-5 days after the date of exposure
- Symptoms of COVID-19 (e.g., fever, shortness of breath, unexpected loss of taste or smell) developed within 14 days of any study admission
- A positive COVID-19 test within 14 days of any study admission or during study admission participation
- Not being fully vaccinated at the time of the first camp admission (according to Center for Disease Control (CDC) guidelines a person is intended to be fully vaccinated after two weeks from either the second dose of the Pfizer or Moderna vaccine, or the single dose of the Johnson \& Johnson vaccine)
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04878120
Start Date
May 14 2021
End Date
June 28 2022
Last Update
May 30 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22902