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

NCT05204134 | Completed Results FDA Device

• 1 other identifier: TP-0009348
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; Control-IQ Technology; automated insulin dosing; automated insulin delivery

Outcome Measures

Primary Outcomes (2)

• Severe Hypoglycemic Events

  Number of Severe Hypoglycemic Events (with altered mental status)

  15 weeks

• Diabetic Ketoacidosis Events

  Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT)

  15 weeks

Secondary Outcomes (25)

• Percent Time < 54 mg/dL, Overall

  15 weeks

• Percent Time < 54 mg/dL, Daytime Outcomes

  15 weeks

• Percent Time < 54 mg/dL, Overnight Outcomes

  15 weeks

• Percent Time < 70 mg/dL, Overall

  15 weeks

• Percent Time < 70 mg/dL, Daytime Outcomes

  15 weeks

Study Arms (1)

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

EXPERIMENTAL

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.

Device: Automated Insulin Delivery Settings Initialization and Adaptation Algorithm

Interventions

Automated Insulin Delivery Settings Initialization and Adaptation Algorithm 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead

Study Sites (1)

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 38323362 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Supervisor Clinical Operations
• Organization: Tandem Diabetes Care

clinicalaffairs@tandemdiabetes.com

+18778016901

Study Officials

• Jordan E Pinsker, MD

  Tandem Diabetes Care, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: March 24, 2022
• Primary Completion: September 9, 2022
• Study Completion: September 29, 2022
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)