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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI
Standard Hybrid Closed Loop Control (USS Virginia)
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Insulin Sensitivity (SI), Adolescent, Insulin Pump, Continuous Glucose Monitor (CGM), Hybrid Closed Loop (HCL), Diabetes Camp

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Virginia Center for Diabetes Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Hybrid Closed Loop Control (USS Virginia)

Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI

Arm Description

Use of Standard Hybrid Closed Loop Control

Use of Hybrid Closed Loop Control with Enhanced Prandial Dosing

Outcomes

Primary Outcome Measures

Low blood glucose index (LBGI)
Low blood glucose index (LBGI) computed from CGM collected in the four hours following the dinner meal

Secondary Outcome Measures

Percentage of time spent below 70 mg/dL
Percentage of time spent below 70 mg/dL
Percentage of time spent in 70-140 and 70-180 mg/dL
Percentage of time spent in 70-140 and 70-180 mg/dL
Percentage of time spent above 180 and 250 mg/dL
Percentage of time spent above 180 and 250 mg/dL
High blood glucose index
High blood glucose index
CGM coefficient of variation
CGM coefficient of variation
Total number and amount of carbohydrate administered as rescue treatments
Total number and amount of carbohydrate administered as rescue treatments

Full Information

First Posted
May 4, 2021
Last Updated
August 16, 2022
Sponsor
University of Virginia
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04878120
Brief Title
Hybrid Closed-Loop Control With Prandial Insulin Dosing Informed by Insulin Sensitivity in Adolescents With Type 1 Diabetes
Official Title
Hybrid Closed-Loop Control With Prandial Insulin Dosing Informed by Insulin Sensitivity in Adolescents With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
June 24, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Insulin Sensitivity (SI), Adolescent, Insulin Pump, Continuous Glucose Monitor (CGM), Hybrid Closed Loop (HCL), Diabetes Camp

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Hybrid Closed Loop Control (USS Virginia)
Arm Type
Active Comparator
Arm Description
Use of Standard Hybrid Closed Loop Control
Arm Title
Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI
Arm Type
Experimental
Arm Description
Use of Hybrid Closed Loop Control with Enhanced Prandial Dosing
Intervention Type
Device
Intervention Name(s)
Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI
Intervention Description
Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI
Intervention Type
Device
Intervention Name(s)
Standard Hybrid Closed Loop Control (USS Virginia)
Intervention Description
Standard Hybrid Closed Loop Control (USS Virginia)
Primary Outcome Measure Information:
Title
Low blood glucose index (LBGI)
Description
Low blood glucose index (LBGI) computed from CGM collected in the four hours following the dinner meal
Time Frame
1 day (Dinner postprandial)
Secondary Outcome Measure Information:
Title
Percentage of time spent below 70 mg/dL
Description
Percentage of time spent below 70 mg/dL
Time Frame
1 day (Dinner postprandial, daytime, nighttime, whole day)
Title
Percentage of time spent in 70-140 and 70-180 mg/dL
Description
Percentage of time spent in 70-140 and 70-180 mg/dL
Time Frame
1 day (Dinner postprandial, daytime, nighttime, whole day)
Title
Percentage of time spent above 180 and 250 mg/dL
Description
Percentage of time spent above 180 and 250 mg/dL
Time Frame
1 day (Dinner postprandial, daytime, nighttime, whole day)
Title
High blood glucose index
Description
High blood glucose index
Time Frame
1 day (Dinner postprandial, daytime, nighttime, whole day)
Title
CGM coefficient of variation
Description
CGM coefficient of variation
Time Frame
1 day (Dinner postprandial, daytime, nighttime, whole day)
Title
Total number and amount of carbohydrate administered as rescue treatments
Description
Total number and amount of carbohydrate administered as rescue treatments
Time Frame
1 day (Dinner postprandial, daytime, nighttime, whole day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiara Fabris, PhD
Organizational Affiliation
University of Virginia Center for Diabetes Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Center for Diabetes Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States

12. IPD Sharing Statement

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

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