Hybrid Closed-Loop Control With Prandial Insulin Dosing Informed by Insulin Sensitivity in Adolescents With Type 1 Diabetes

Overview

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 with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes camp.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 24, 2022

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 insulin pump and a continuous glucose monitoring (CGM) system. Participants will be randomized 1:1 to the use of the standard HCL system (USS Virginia) vs. the HCL system with the smart bolus calculator first. The trial will be held at a local camp facility and will consist of EITHER a weeklong (6 day/5 night) camp OR two long weekends (4 day/3 night) separated by a washout period of about one week.

Interventions

  • Device: Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI
    • Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI
  • Device: Standard Hybrid Closed Loop Control (USS Virginia)
    • Standard Hybrid Closed Loop Control (USS Virginia)

Arms, Groups and Cohorts

  • Active Comparator: Standard Hybrid Closed Loop Control (USS Virginia)
    • Use of Standard Hybrid Closed Loop Control
  • Experimental: Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI
    • Use of Hybrid Closed Loop Control with Enhanced Prandial Dosing

Clinical Trial Outcome Measures

Primary Measures

  • Low blood glucose index (LBGI)
    • Time Frame: 1 day (Dinner postprandial)
    • Low blood glucose index (LBGI) computed from CGM collected in the four hours following the dinner meal

Secondary Measures

  • Percentage of time spent below 70 mg/dL
    • Time Frame: 1 day (Dinner postprandial, daytime, nighttime, whole day)
    • Percentage of time spent below 70 mg/dL
  • Percentage of time spent in 70-140 and 70-180 mg/dL
    • Time Frame: 1 day (Dinner postprandial, daytime, nighttime, whole day)
    • Percentage of time spent in 70-140 and 70-180 mg/dL
  • Percentage of time spent above 180 and 250 mg/dL
    • Time Frame: 1 day (Dinner postprandial, daytime, nighttime, whole day)
    • Percentage of time spent above 180 and 250 mg/dL
  • High blood glucose index
    • Time Frame: 1 day (Dinner postprandial, daytime, nighttime, whole day)
    • High blood glucose index
  • CGM coefficient of variation
    • Time Frame: 1 day (Dinner postprandial, daytime, nighttime, whole day)
    • CGM coefficient of variation
  • Total number and amount of carbohydrate administered as rescue treatments
    • Time Frame: 1 day (Dinner postprandial, daytime, nighttime, whole day)
    • Total number and amount of carbohydrate administered as rescue treatments

Participating in This Clinical Trial

Inclusion Criteria

1. Age ≥12 and <18 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of T1D for at least one year 3. Currently using insulin for at least six months 4. Currently using an insulin pump for at least three months 5. Currently using a CGM system for at least three months 6. Having at least 75% of CGM data over the previous four weeks 7. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections 8. Access to internet and willingness to upload data during the study as needed 9. For females, not currently known to be pregnant or breastfeeding 10. A negative urine pregnancy test will be required for all females of childbearing potential 11. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use 12. 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 13. Total daily insulin dose (TDD) of at least 10 U/day 14. 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) 15. Willingness to eat at least 40 grams of carbohydrates per meal 16. An understanding and willingness to follow the protocol and signed informed consent 17. Participants and parent/legal guardians will be proficient in reading and writing in English 18. Willingness to comply with COVID-19 precautions as defined by the study team 19. 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 Criteria:

1. 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 2. History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment 3. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment 4. Pregnancy or intent to become pregnant during the trial 5. Currently breastfeeding or planning to breastfeed 6. Currently being treated for a seizure disorder 7. Planned surgery during study duration 8. History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted) 9. Treatment with any non-insulin glucose-lowering agent (metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) 10. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. 11. Use of an insulin delivery mechanism that is not downloadable by the participant or study team 12. 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 13. Symptoms of COVID-19 (e.g., fever, shortness of breath, unexpected loss of taste or smell) developed within 14 days of any study admission 14. A positive COVID-19 test within 14 days of any study admission or during study admission participation 15. 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)

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Virginia
  • Collaborator
    • Juvenile Diabetes Research Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chiara Fabris, PhD, Assistant Professor – University of Virginia
  • Overall Official(s)
    • Chiara Fabris, PhD, Principal Investigator, University of Virginia Center for Diabetes Technology

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