Clinical trial NCT05111301: Control-IQ Technology in Individuals With Type 2 Diabetes
Official title: Control-IQ Technology in Individuals With Type 2 Diabetes (2IQ)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Keywords: type 2 diabetes
Control-IQ technology
automated insulin dosing
automated insulin delivery
Lead sponsor: Tandem Diabetes Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jaeb Center for Health Research
First posted: 2021-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, prospective clinical trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CGM Time Below 54 mg/dL
timeFrame: 14 weeks
measure: CGM Time Above 180 mg/dL
timeFrame: 14 weeks
Secondary outcomes:
measure: CGM Time In Range 70-180 mg/dL
timeFrame: 14 weeks
measure: CGM Time Below 70 mg/dL
timeFrame: 14 weeks
measure: CGM Time Above 250 mg/dL
timeFrame: 14 weeks
measure: CGM Time In Range 70-140 mg/dL
timeFrame: 14 weeks
measure: CGM Mean Glucose mg/dL
timeFrame: 14 weeks
measure: Coefficient of Variation (CV)
timeFrame: 14 weeks
Other outcomes:
measure: Severe Hypoglycemia (Needing Assistance)
timeFrame: 14 weeks
measure: DKA
timeFrame: 14 weeks
measure: Hyperosmolar Hyperglycemic Syndrome
timeFrame: 14 weeks
measure: All Serious Adverse Events
timeFrame: 14 weeks
measure: Unanticipated Adverse Device Effects
timeFrame: 14 weeks
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
Study officials:
affiliation: Icahn School of Medicine at Mt. Sinai
name: Carol Levy, MD
role: STUDY_CHAIR
References:
citation: 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.