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

NCT03804983 | Completed Results FDA Device

• 1 other identifier: 180030
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes Mellitus

Keywords

Artificial Pancreas (AP); Insulin Pump; Continuous Glucose Monitor (CGM); MyTDI; Hybrid Closed Loop (HCL); Total Daily Insulin (TDI)

Outcome Measures

Primary Outcomes (1)

• Percent Time in Range at Home Pre/Post Intervention at Home

  The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.

  5 days post camp (home) compared to 5 days before camp (baseline)

Secondary Outcomes (24)

• Average CGM at Home

  5 days post camp (home) compared to 5 days before camp (baseline)

• Average CGM at Camp

  2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)

• Percentage of CGM Values Below 50mg/dL at Home

  5 days post camp (home) compared to 5 days before camp (baseline)

• Percentage of CGM Values Below 50mg/dL at Camp

  2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)

• Percentage of CGM Values Below 54mg/dL at Camp

  2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)

Study Arms (2)

Hybrid Closed Loop (HCL)

ACTIVE COMPARATOR

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.

Device: Hybrid Closed Loop (HCL)

Control-IQ with MyTDI

EXPERIMENTAL

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.

Device: Control-IQ with MyTDI

Interventions

Hybrid Closed Loop (HCL) 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.

Hybrid Closed Loop (HCL)

Control-IQ with MyTDI 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.

Control-IQ with MyTDI

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• Tandem Diabetes Care, Inc.: collaborator
• DexCom, Inc.: collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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.

  PMID: 32119790 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Marc Breton, PhD
• Organization: University of Virginia Center for Diabetes Technology

mb6nt@virginia.edu

434-982-6484

Study Officials

• Marc D. Breton, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: January 15, 2019
• Primary Completion: February 16, 2019
• Study Completion: February 16, 2019
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Generally, data will be made available after the primary publications of each study.
• Access Criteria: Complete data sets will be provided to industry partners who would use the data for regulatory clearance (PMA - pre-market approval) of the tested artificial pancreas system. This will be done in response to the specific requirements of RFA-DK-14-024 for this project to "…generate data able to satisfy safety and efficacy requirements by regulatory agencies regarding the clinical testing of artificial pancreas device systems" in the target population of people with type 1 diabetes.

Locations

US (1)