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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804983
• Other study ID #: 180030
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: February 16, 2019

Study information

• Verified date: September 2020
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 16, 2019
• Est. primary completion date: February 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Virginia Center for Diabetes Technology	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	DexCom, Inc., Tandem Diabetes Care, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schoelwer MJ, Robic JL, Gautier T, Fabris C, Carr K, Clancy-Oliveri M, Brown SA, Anderson SM, DeBoer MD, Cherñavvsky 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Total daily insulin at home	sum of the recorded insulin injection over the time frame in units	5 days
Secondary	Change in Total daily insulin at camp	sum of the recorded insulin injection over the time frame in units	2 days
Secondary	Change in Total meal carbohydrates at home	sum of the meal sized recorded over the time frame	5 days
Secondary	Change in Total meal carbohydrates at camp	sum of the meal sized recorded over the time frame	2 days
Secondary	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
Secondary	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
Secondary	Change in number of Hypoglycemia treatment at home	Sum of the number of CHO treatments recorded over the time frame	5 days
Secondary	Change in number of Hypoglycemia treatment at camp	Sum of the number of CHO treatments recorded over the time frame	2 days
Secondary	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
Secondary	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