Status:
COMPLETED
Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Tandem Diabetes Care, Inc.
DexCom, Inc.
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
12-18 years
Phase:
NA
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 tech...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03804983
Start Date
January 15 2019
End Date
February 16 2019
Last Update
August 1 2024
Active Locations (1)
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1
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903