Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.

Key facts

Study ID

NCT05204134

Run by

Tandem Diabetes Care, Inc.

People needed

33

Starts

2022-03-24

Expected to finish

2022-09-29

Last updated by the study team

2024-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects ≥ age 18 years
• Clinical diagnosis of type 1 diabetes for at least one year
• Using a basal/bolus regimen by injection (MDI therapy)
• Total daily dose ≥10 units/day
• Willing to use only aspart (novolog) or lispro (humalog) U-100 insulin with the study pump.
• A1c ≥ 7.5% and ≤ 11% at screening
• Not pregnant or planning a pregnancy during the time period of the study.
• Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
• Willingness to follow study procedures and a signed informed consent form

You may not qualify if…

• Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months
• Two or more episodes of diabetic ketoacidosis in the past 6 months
• Inpatient psychiatric treatment in the past 6 months
• History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study
• Significant chronic kidney disease or hemodialysis
• Significant liver disease
• History of adrenal insufficiency
• Hypothyroidism or hyperthyroidism that is not appropriately treated
• Other chronic disease/condition determined by investigator to interfere with participation in the study
• Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study
• Use of long-acting insulin, inhaled insulin (Afrezza), or use of any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than Metformin with the study pump
• Subject is pregnant or lactating or intending to become pregnant before or during participation in this study
• Investigator judgement that subject would not be able to complete the trial

Where it is running

• Barbara Davis Center — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.