Control-IQ Technology in Individuals With Type 2 Diabetes

Type 2 Diabetes Treated With Insulin Clinical Trial

— 2IQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111301
• Other study ID #: TP-0009569
• Status: Completed
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: August 18, 2022

Study information

• Verified date: February 2024
• Source: Tandem Diabetes Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 18, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Diabetes and Endocrinology	Austin	Texas
United States	Icahn School of Medicine at Mt. Sinai	New York	New York
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Tandem Diabetes Care, Inc.	Jaeb Center for Health Research

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severe Hypoglycemia (Needing Assistance)	The number of severe hypoglycemic events (needing assistance)	14 weeks
Other	DKA	The number of DKA events	14 weeks
Other	Hyperosmolar Hyperglycemic Syndrome	The number of Hyperosmolar Hyperglycemic Syndrome events	14 weeks
Other	All Serious Adverse Events	The number of Serious Adverse Events	14 weeks
Other	Unanticipated Adverse Device Effects	The number of Unanticipated Adverse Device Effects	14 weeks
Primary	CGM Time Below 54 mg/dL	CGM-measured percentage below 54 mg/dl, compared to baseline	14 weeks
Primary	CGM Time Above 180 mg/dL	CGM-measured percentage above 180 mg/dl, compared to baseline	14 weeks
Secondary	CGM Time In Range 70-180 mg/dL	CGM-measured percentage in range 70-180 mg/dl, compared to baseline	14 weeks
Secondary	CGM Time Below 70 mg/dL	CGM-measured percentage below 70 mg/dl, compared to baseline	14 weeks
Secondary	CGM Time Above 250 mg/dL	CGM-measured percentage above 250 mg/dl, compared to baseline	14 weeks
Secondary	CGM Time In Range 70-140 mg/dL	CGM-measured percentage in range 70-140 mg/dl, compared to baseline	14 weeks
Secondary	CGM Mean Glucose mg/dL	CGM measured mean glucose mg/dL, compared to baseline	14 weeks
Secondary	Coefficient of Variation (CV)	CGM measured glucose variability measured with the coefficient of variation (CV), compared to baseline	14 weeks