Control-IQ Technology in Individuals With Type 2 Diabetes

NCT05111301 | Completed Results FDA Device

• 1 other identifier: TP-0009569
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

A prospective, multicenter study of 6 weeks of home use of Control-IQ technology in individuals with type 2 diabetes age 18 and older.

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

type 2 diabetes; Control-IQ technology; automated insulin dosing; automated insulin delivery

Outcome Measures

Primary Outcomes (2)

• CGM Time Below 54 mg/dL

  CGM-measured percentage below 54 mg/dl, compared to baseline

  14 weeks

• CGM Time Above 180 mg/dL

  CGM-measured percentage above 180 mg/dl, compared to baseline

  14 weeks

Secondary Outcomes (6)

• CGM Time In Range 70-180 mg/dL

  14 weeks

• CGM Time Below 70 mg/dL

  14 weeks

• CGM Time Above 250 mg/dL

  14 weeks

• CGM Time In Range 70-140 mg/dL

  14 weeks

• CGM Mean Glucose mg/dL

  14 weeks

Other Outcomes (5)

• Severe Hypoglycemia (Needing Assistance)

  14 weeks

• DKA

  14 weeks

• Hyperosmolar Hyperglycemic Syndrome

  14 weeks

Study Arms (2)

Basal Insulin Only (Group A)

EXPERIMENTAL

* 2 to 4 week CGM run-in * 2 to 4 week pump run-in * 6 weeks Control-IQ technology use

Device: Control-IQ technology 1.5

Multiple Daily Injections (Group B)

EXPERIMENTAL

* 2 to 4 week CGM run-in * 2 to 4 week pump run-in * 6 weeks Control-IQ technology use

Device: Control-IQ technology 1.5

Interventions

Control-IQ technology 1.5 DEVICE

All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor. Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.

Basal Insulin Only (Group A); Multiple Daily Injections (Group B)

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old and residing in the US
• Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year
• Using a stable insulin dose for at least 3 months, to include A) basal insulin only, or B) MDI, to include CSII (including use of AID systems other than Tandem Control-IQ technology)
• Total daily insulin dose ≤200 units/day
• Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin
• For females, not currently known to be pregnant
• If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• HbA1c ≥ 7.5% and ≤ 12% at screening
• Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
• Be willing to exercise for 30 minutes or more at least once per week during the main phase of the study
• Has the ability to read and understand written English
• Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study.

You may not qualify if:

• Prior use of Tandem t:slim X2 insulin pump with Control-IQ technology
• Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months
• History of 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.
• History of significant heart disease, lung disease, liver disease, chronic kidney disease, or other systemic disease determined by investigator to interfere with the study, or make required exercise unsafe
• History of significant vision, hearing, or dexterity problems that will impair use of the closed loop system
• Use of glucocorticoids, beta blockers, sulfonylureas, meglitinides or other medications specifically listed in the protocol or determined by investigator to interfere with the study
• Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or other adjuvant medication specifically listed in the protocol, or starting a new glucose lowering agent during the trial.
• Unstable dose of any medication used for weight loss, as listed in the protocol, or starting a new medication for weight loss during the trial.
• Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (\>450 ms)
• History of hemodialysis
• History of adrenal insufficiency
• Uncontrolled hypo- or hyperthyroidism
• Significant diabetes related complications, based on investigator assessment
• Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care, Inc.

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead
• Jaeb Center for Health Research: collaborator

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Texas Diabetes and Endocrinology

Austin, Texas, 78731, United States

Location

Related Publications (1)

• Levy CJ, Raghinaru D, Kudva YC, Pandit K, Blevins T, Casaubon L, Desjardins D, Levister CM, O'Malley G, Reid C, Lum J, Kollman C, Beck RW. Beneficial Effects of Control-IQ Automated Insulin Delivery in Basal-Bolus and Basal-Only Insulin Users With Type 2 Diabetes. Clin Diabetes. 2024 Winter;42(1):116-124. doi: 10.2337/cd23-0025. Epub 2023 Aug 28.

  PMID: 38230336 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

clinicalaffairs@tandemdiabetes.com

(877) 801-6901

Study Officials

• Carol Levy, MD

  Icahn School of Medicine at Mt. Sinai

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, prospective clinical trial

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 8, 2021
• Study Start: November 30, 2021
• Primary Completion: August 10, 2022
• Study Completion: August 18, 2022
• Last Updated: March 6, 2024
• Results First Posted: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)