Control-IQ Technology in Individuals With Type 2 Diabetes (2IQ)

Control-IQ Technology in Individuals With Type 2 Diabetes (2IQ)

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Device: Control-IQ technology 1.5

Detailed Description

The objective of this prospective, multicenter study is to assess safety and explore glycemic outcomes associated with use of Control-IQ technology in adults with type 2 diabetes who require insulin. After an initial run-in period, all participants will use the study system (pump and CGM) for 6 weeks. Participants will perform exercise challenges once each week during the study.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes and Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Basal Insulin Only (Group A); 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; 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.
Experimental: Multiple Daily Injections (Group B); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM Time In Range 70-180 mg/dL	CGM-measured percentage in range 70-180 mg/dl, compared to baseline	14 weeks
CGM Time Below 70 mg/dL	CGM-measured percentage below 70 mg/dl, compared to baseline	14 weeks
CGM Time Above 250 mg/dL	CGM-measured percentage above 250 mg/dl, compared to baseline	14 weeks
CGM Time In Range 70-140 mg/dL	CGM-measured percentage in range 70-140 mg/dl, compared to baseline	14 weeks
CGM Mean Glucose mg/dL	CGM measured mean glucose mg/dL, compared to baseline	14 weeks
Coefficient of Variation (CV)	CGM measured glucose variability measured with the coefficient of variation (CV), compared to baseline	14 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe Hypoglycemia (Needing Assistance)	The number of severe hypoglycemic events (needing assistance)	14 weeks
DKA	The number of DKA events	14 weeks
Hyperosmolar Hyperglycemic Syndrome	The number of Hyperosmolar Hyperglycemic Syndrome events	14 weeks
All Serious Adverse Events	The number of Serious Adverse Events	14 weeks
Unanticipated Adverse Device Effects	The number of Unanticipated Adverse Device Effects	14 weeks

Collaborators and Investigators

• Sponsor: Tandem Diabetes Care, Inc.
• Collaborators: Jaeb Center for Health Research
• Investigators: Study Chair: Carol Levy, MD, Icahn School of Medicine at Mt. Sinai

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): August 10, 2022
• Study Completion (Actual): August 18, 2022

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: type 2 diabetes; automated insulin delivery; automated insulin dosing; Control-IQ technology
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: TP-0009569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes