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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Hybrid Closed Loop (HCL); Device: Control-IQ with 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Center for Diabetes Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.
Experimental: 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/TDI04:00-11:00 CR=360/TDI11:00-00:00 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change between 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average CGM at home	number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame.	5 days
Change in average CGM at camp	number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame.	2 days
Change in Percent CGM below 50mg/dL at home	the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	5 days
Change in Percent CGM below 50mg/dL at camp	the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	5 days
Change in Percent CGM below 54mg/dL at camp	the number of CGM values falling below 54mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	2 days
Change in Percent below 60mg/dL at home	the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	5 days
Change in Percent below 60mg/dL at camp	the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	2 days
Change in Percent CGM below 70mg/dL at home	the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	5 days
Change in Percent CGM below 70mg/dL at camp	the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	2 days
Change in Percent CGM between 70mg/dL and 180mg/dL at camp	the number of CGM values falling between 70mg/dL and 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	2 days
Change in Percent CGM above 180mg/dL at home	the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	5 days
Change in Percent CGM above 180mg/dL at camp	the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	2 days
Change in Percent CGM above 250mg/dL at home	the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	5 days
Change in Percent CGM above 250mg/dL at camp	the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	5 days2
Change in Percent CGM above 300mg/dL at home	the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	5 days
Change in Percent CGM above 300mg/dL at camp	the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.	2 days
Change in Total daily insulin at home	sum of the recorded insulin injection over the time frame in units	5 days
Change in Total daily insulin at camp	sum of the recorded insulin injection over the time frame in units	2 days
Change in Total meal carbohydrates at home	sum of the meal sized recorded over the time frame	5 days
Change in Total meal carbohydrates at camp	sum of the meal sized recorded over the time frame	2 days
Change in Number of hypoglycemic events at home	Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)	5 days
Change in Number of hypoglycemic events at camp	Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)	2 days
Change in number of Hypoglycemia treatment at home	Sum of the number of CHO treatments recorded over the time frame	5 days
Change in number of Hypoglycemia treatment at camp	Sum of the number of CHO treatments recorded over the time frame	2 days
Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at home	Sum of the amount of carbohydrates used for treatments recorded over the time frame	5 days
Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at camp	Sum of the amount of carbohydrates used for treatments recorded over the time frame	2 days

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: DexCom, Inc.; Tandem Diabetes Care, Inc.
• Investigators: Principal Investigator: Marc D. Breton, PhD, University of Virginia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): February 16, 2019
• Study Completion (Actual): February 16, 2019

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Insulin Pump; Hybrid Closed Loop (HCL); MyTDI; Total Daily Insulin (TDI)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 180030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
• IPD Sharing Time Frame: Generally, data will be made available after the primary publications of each study.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes