Control-IQ Technology in Individuals With Type 2 Diabetes | NCT05111301

NCT05111301

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Jaeb Center for Health Research	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Measure	Description	Time Frame
Severe Hypoglycemia (Needing Assistance)	The number of severe hypoglycemic events (needing assistance)	14 weeks
DKA	The number of DKA events

Eligibility Module

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.

Name	Affiliation	Role
Carol Levy, MD	Icahn School of Medicine at Mt. Sinai	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States
Icahn School of Medicine at Mt. Sinai

PubMed Identifier	Type	Citation	Retractions
38230336	Result	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.

Arm/Group Information

ID	Title	Description
FG000	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 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.
FG001	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 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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 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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

CGM Time Below 54 mg/dL

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

Posted

Median

Inter-Quartile Range

percentage of time

14 weeks

ID	Title	Description
OG000	Overall	2 to 4 week CGM run-in with insulin injections (baseline) 2 to 4 week open loop with insulin pump and Dexcom G6 sensor 6 weeks Control-IQ technology 1.5 use 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.
OG001	Basal Insulin Only (Group A)	2 to 4 week CGM run-in with insulin injections (baseline) 2 to 4 week open loop with insulin pump and Dexcom G6 sensor 6 weeks Control-IQ technology 1.5 use 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 19, 2021	Aug 2, 2023	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Nov 17, 2021	Aug 2, 2023	SAP_001.pdf

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases