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

Not Applicable

Completed

Conditions: Type 1 Diabetes Mellitus

Interventions: Device: Control-IQ with MyTDI
Device: Hybrid Closed Loop (HCL)

Registration Number: NCT03804983

Lead Sponsor: University of Virginia

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control-IQ with MyTDI	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.
Hybrid Closed Loop (HCL)	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.

Primary Outcome Measures

Name	Time	Method
Percent Time in Range at Home Pre/Post Intervention at Home	5 days post camp (home) compared to 5 days before camp (baseline)	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.

Secondary Outcome Measures

Name	Time	Method
Average CGM at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)	average of CGM values within time frame
Percentage of CGM Values Below 60mg/dL at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)	the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values \<60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp	2 days during camp admission (Camp)	Sum of the amount of carbohydrates used for treatments recorded over the time frame
Change in Hypoglycemia Events at Home	5 days post camp (home) compared to 5 days before camp (baseline)	change in number of hypoglycemia between baseline and home
Average CGM at Home	5 days post camp (home) compared to 5 days before camp (baseline)	Average of available CGM values within time frame
Percentage of CGM Values Below 54mg/dL at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)	the percentage of CGM values falling below 54mg/dL. computed as the number of CGM values \<54mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Percentage of CGM Values Above 180mg/dL at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)	the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values \>180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Percentage of CGM Values Below 50mg/dL at Home	5 days post camp (home) compared to 5 days before camp (baseline)	the percentage of CGM values falling below 50mg/dL, calculated as the number of CGM values \<50mg/dL within the time frame divided by the total number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Percentage of CGM Values Below 50mg/dL at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)	the percentage of CGM values falling below 50mg/dL, computed as the number of CGM values \<50mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)	the percentage of CGM values falling between 70mg/dL and 180mg/dL, computed as the number of CGM values \<=180mg/dL and \>70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Percentage of CGM Values Above 180mg/dL at Home	5 days post camp (home) compared to 5 days before camp (baseline)	the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values \>180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Percentage of CGM Values Above 250mg/dL at Home	5 days post camp (home) compared to 5 days before camp (baseline)	the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values \>250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Percentage of CGM Values Above 250mg/dL at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)	the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values \>250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Percentage of CGM Values Above 300mg/dL at Home	5 days post camp (home) compared to 5 days before camp (baseline)	the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values \>300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Percentage of CGM Values Above 300mg/dL at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)	the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values \>300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Total Daily Insulin at Home	5 days post camp (home) compared to 5 days before camp (baseline)	sum of the recorded insulin injection over the time frame in units
Change in Total Meal Carbohydrates at Home	5 days post camp (home) compared to 5 days before camp (baseline)	sum of the meal sized recorded over the time frame
Change in Number of Hypoglycemic Events at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)	Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)
Percentage of CGM Values Below 60mg/dL at Home	5 days post camp (home) compared to 5 days before camp (baseline)	the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values \<60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Percentage of CGM Values Below 70mg/dL at Home	5 days post camp (home) compared to 5 days before camp (baseline)	the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values \<70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Percentage of CGM Values Below 70mg/dL at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)	the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values \<70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Total Daily Insulin at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)	sum of the recorded insulin injection over the time frame in units
Change in Total Meal Carbohydrates at Camp	2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)	sum of the meal sized recorded over the time frame
Number of Hypoglycemia Treatment at Camp	2 days during camp admission (Camp)	Sum of the number of CHO treatments recorded over the time frame