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

University of Virginia

Status: Completed

Conditions: Type 1 Diabetes Mellitus

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03804983

180030

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Hybrid Closed Loop (HCL)

Active Comparator group

Description:

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.

Treatment:

Device: Hybrid Closed Loop (HCL)

Control-IQ with MyTDI

Experimental group

Description:

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.

Treatment:

Device: Control-IQ with MyTDI