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

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT03804983

Run by

University of Virginia

People needed

22

Starts

2019-01-15

Expected to finish

2019-02-16

Last updated by the study team

2024-08-01

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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