Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin

NCT ID: NCT03804983

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2019-02-16

Brief Summary

The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.

Detailed Description

This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.

Once deemed eligible, participants and their parent(s) will be trained on the use of the Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system. Participants will then use the this study equipment with their home insulin parameters at home for at home for 5 days. Participants will then come to the ski resort to participate in a 72-hour ski admission. Upon arrival, each participant will be randomized to either the using the Control-IQ system with their usual insulin parameters during the ski study and the at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and the at-home 5 days at home study. Study duration for each participant will require 5 study visits over about 2 weeks.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Hybrid Closed Loop (HCL)

Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.

Group Type: ACTIVE_COMPARATOR

Hybrid Closed Loop (HCL)

Intervention Type: DEVICE

Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.

Control-IQ with MyTDI

Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:

• A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
• A single correction factor (CF) of 1650/TDI will be implemented across the whole day
• Carbohydrate ratios (CR) will be set at:

• 00:00-04:00 CR=450/TDI
• 04:00-11:00 CR=360/TDI
• 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.

Group Type: EXPERIMENTAL

Control-IQ with MyTDI

Intervention Type: DEVICE

Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.

Interventions

Hybrid Closed Loop (HCL)

Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.

Intervention Type: DEVICE

Control-IQ with MyTDI

Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Criteria for documented hyperglycemia (at least 1 must be met):

• Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required)
• Diagnosis of type 1 diabetes is based on the investigator's judgement
• Criteria for requiring insulin at diagnosis (both criteria must be met):

• Daily insulin therapy for ≥ 6 months
• Insulin pump therapy for ≥ 3 months
• Age 12-18 years
• Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or aspart.
• Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month.
• Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study.
• For females, not pregnant or breastfeeding. Female subjects who are sexually active should agree to use birth control during the study.
• Total daily insulin dose (TDD) at least 10 U/day.

Exclusion Criteria

• Diabetic ketoacidosis in the past 6 months
• Hypoglycemic seizure or loss of consciousness in the past 6 months
• History of seizure disorder
• History of any heart disease including coronary artery disease, heart failure, or arrhythmias
• History of altitude sickness
• Chronic pulmonary conditions that could impair oxygenation
• Cystic fibrosis
• Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgement of the investigator, would be a contraindication to participation in the study.
• History of ongoing renal disease (other than microalbuminuria).
• Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir, or Glargine).
• Pregnancy
• Presence of a febrile illness within 24 hours of the Ski Admission
• Medical or psychiatric conditions that in the judgement of the investigator might interfere with the completion of the protocol such as:

• Inpatient psychiatric treatment in the past 6 months
• Uncontrolled adrenal insufficiency
• Alcohol abuse

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tandem Diabetes Care, Inc.

INDUSTRY

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Marc Breton

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc D. Breton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Countries

United States

References

Schoelwer MJ, Robic JL, Gautier T, Fabris C, Carr K, Clancy-Oliveri M, Brown SA, Anderson SM, DeBoer MD, Chernavvsky DR, Breton MD. Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Based on Total Daily Insulin in Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2020 Aug;22(8):594-601. doi: 10.1089/dia.2019.0471. Epub 2020 Mar 2.

Reference Type: BACKGROUND

PMID: 32119790 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

180030

Identifier Type: -

Identifier Source: org_study_id