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

NCT ID: NCT05204134

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2022-09-29

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 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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Automated Insulin Delivery Settings Initialization and Adaptation Algorithm

Intervention Type: DEVICE

All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals.

Interventions

Automated Insulin Delivery Settings Initialization and Adaptation Algorithm

All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tandem Diabetes Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordan E Pinsker, MD

Role: STUDY_CHAIR

Tandem Diabetes Care, Inc.

Locations

Barbara Davis Center

Aurora, Colorado, United States

Countries

United States

References

Shah VN, Akturk HK, Trahan A, Piquette N, Wheatcroft A, Schertz E, Carmello K, Mueller L, White K, Fu L, Sassan-Katchalski R, Messer LH, Habif S, Constantin A, Pinsker JE. Safety and Feasibility Evaluation of Automated User Profile Settings Initialization and Adaptation With Control-IQ Technology. J Diabetes Sci Technol. 2024 Nov;18(6):1281-1287. doi: 10.1177/19322968241229074. Epub 2024 Feb 7.

Reference Type: RESULT

PMID: 38323362 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TP-0009348

Identifier Type: -

Identifier Source: org_study_id