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

Tandem Diabetes Care

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Automated Insulin Delivery Settings Initialization and Adaptation Algorithm

Study type: Interventional

Funder types: Industry

Identifiers

NCT05204134

TP-0009348

Details and patient eligibility

About

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

Full 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 insulin delivery settings and adapt them over time, faster than typical HCP visits, users onboarding from multiple daily injections (MDI) will reach optimal glycemic outcomes faster.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular Updates

Experimental group

Description:

After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use.

Treatment:

Device: Automated Insulin Delivery Settings Initialization and Adaptation Algorithm