Status:
COMPLETED
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Lead Sponsor:
Tandem Diabetes Care, Inc.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.
Detailed Description
This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of Control-IQ technology use. By using an algorithm to more accurately initialize ins...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05204134
Start Date
March 24 2022
End Date
September 29 2022
Last Update
April 5 2024
Active Locations (1)
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1
Barbara Davis Center
Aurora, Colorado, United States, 80045