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

University of Virginia22 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus

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.

Control-IQ with MyTDIDEVICE

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

Secondary Outcomes

Average CGM at Home

Average of available CGM values within time frame

Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

Average CGM at Camp

average of CGM values within time frame

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

Percentage of CGM Values Below 50mg/dL at Home

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.

Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

Percentage of CGM Values Below 50mg/dL at Camp

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.

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

Percentage of CGM Values Below 54mg/dL at Camp

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.

Data from ClinicalTrials.gov

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

Percentage of CGM Values Below 60mg/dL at Home

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.

Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

Percentage of CGM Values Below 60mg/dL at Camp

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

Percentage of CGM Values Below 70mg/dL at Home

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.

Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

Percentage of CGM Values Below 70mg/dL at Camp

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

Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp

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.

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

Percentage of CGM Values Above 180mg/dL at Home

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.

Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

Percentage of CGM Values Above 180mg/dL at Camp

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

Percentage of CGM Values Above 250mg/dL at Home

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.

Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

Percentage of CGM Values Above 250mg/dL at Camp

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

Percentage of CGM Values Above 300mg/dL at Home

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.

Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

Percentage of CGM Values Above 300mg/dL at Camp

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

Change in Total Daily Insulin at Home

sum of the recorded insulin injection over the time frame in units

Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

Change in Total Daily Insulin at Camp

sum of the recorded insulin injection over the time frame in units

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

Change in Total Meal Carbohydrates at Home

sum of the meal sized recorded over the time frame

Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

Change in Total Meal Carbohydrates at Camp

sum of the meal sized recorded over the time frame

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

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)

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

Number of Hypoglycemia Treatment at Camp

Sum of the number of CHO treatments recorded over the time frame

Time frame: 2 days during camp admission (Camp)

Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp

Sum of the amount of carbohydrates used for treatments recorded over the time frame

Time frame: 2 days during camp admission (Camp)

Change in Hypoglycemia Events at Home

change in number of hypoglycemia between baseline and home

Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)