Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ)

A prospective, single-arm study of 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ technology in individuals with type 1 diabetes who will plan to use at least one basal rate > 3 units/hr.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: t:slim X2 insulin pump with Control-IQ technology 1.5

Detailed Description

The objectives of the study are to assess safety and explore glycemic outcomes with use of an automated insulin dosing (AID) system (t:slim X2 insulin pump with Control-IQ technology v1.5) in adults with type 1 diabetes who will plan to use at least one basal rate > 3 units/hr. Up to 60 participants may be recruited.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Diabetes Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • International Diabetes Center
  • Utah
    • Sandy, Utah, United States, 84093
      • Diabetes & Endocrine Treatment Specialists

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
• Diagnosis of type 1 diabetes for at least 1 year
• Currently using an insulin pump (of any brand) for at least 3 months, and will plan to use at least one basal rate above 3 units/hr with the study pump
• HbA1c < 10.5%
• Weight ≤ 200 kg
• Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation.
• Participant has agreed to participate in the study; and has read, understood and signed the informed consent form (ICF); and has agreed to follow all study procedures, including suspending use of any personal CGM for the duration of the clinical trial once the study CGM is in use.
• 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 with the study pump.
• Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
• Willing and able to perform the study exercise and meal challenges.
• Have a care partner, trained in hypoglycemia and hyperglycemia treatment guidelines, present during the challenges and until the next day.
• Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including ability to respond to alerts and alarms, and to provide basic diabetes self-management.

Exclusion Criteria:

• More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
• More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
• 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.
• For Female: Currently pregnant or planning to become pregnant during the time period of study participation
• Use of sulfonylureas, meglitinides or other medications specifically listed in protocol or determined by investigator to interfere with the study
• Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or DPP-4 inhibitor as listed in the protocol, or starting a new non-insulin glucose lowering or weight loss agent during the trial
• Hemophilia or any other bleeding disorder
• History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
• History of allergic reaction to Humalog or Novolog
• Use of glucocorticoids or other medications determined by investigator to interfere with study
• Abnormal screening electrocardiogram consistent with increased risk during study exercise activities, such as arrhythmia, ischemia, or prolonged QTc interval. Investigator will review all electrocardiograms
• Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
• History of adrenal insufficiency
• History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
• History of gastroparesis
• A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
• Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
• Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: t:slim X2 insulin pump with Control-IQ technology; Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.	Device: t:slim X2 insulin pump with Control-IQ technology 1.5; t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Severe Hypoglycemic Events	Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during the entire study period	3 months
Number of Diabetic Ketoacidosis Events	Number of diabetic ketoacidosis events during the entire study period	3 months
Unanticipated Adverse Device Effects	Number of unanticipated adverse device effects during the entire study period	3 months
Other Serious Adverse Events	Number of serious adverse events during the entire study period	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM Time <54 mg/dL Overall	Percent time CGM glucose <54 mg/dL overall	3 months
CGM Time <54 mg/dL Daytime Only	Percent time CGM glucose <54 mg/dL daytime only (06:00 - 24:00)	3 months
CGM Time <54 mg/dL Nighttime Only	Percent time CGM glucose <54 mg/dL nighttime only (00:00 - 06:00)	3 months
CGM Time <70 mg/dL Overall	Percent time CGM glucose <70 mg/dL overall	3 months
CGM Time <70 mg/dL Daytime Only	Percent time CGM glucose <70 mg/dL daytime only (06:00 - 24:00)	3 months
CGM Time <70 mg/dL Nighttime Only	Percent time CGM glucose <70 mg/dL nighttime only (00:00 - 06:00)	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	Change in Hemoglobin A1c from baseline	3 months
CGM Time in Range 70-180 mg/dL Overall	Percent time CGM glucose in range 70-180 mg/dl overall	3 months
CGM Time in Range 70-180 mg/dL Daytime Only	Percent time CGM glucose in range 70-180 mg/dl daytime only (06:00 - 24:00)	3 months
CGM Time in Range 70-180 mg/dL Nighttime Only	Percent time CGM glucose in range 70-180 mg/dl nighttime only (00:00 - 06:00)	3 months
CGM Time >180 mg/dL Overall	Percent time CGM glucose> 180 mg/dL overall	3 months
CGM Time >180 mg/dL Daytime Only	Percent time CGM glucose> 180 mg/dL daytime only (06:00 - 24:00)	3 months
CGM Time >180 mg/dL Nighttime Only	Percent time CGM glucose> 180 mg/dL nighttime only (00:00 - 06:00)	3 months
CGM Time >250 mg/dL Overall	Percent time CGM glucose >250 mg/dL overall	3 months
CGM Time >250 mg/dL Daytime Only	Percent time CGM glucose >250 mg/dL daytime only (06:00 - 24:00)	3 months
CGM Time >250 mg/dL Nighttime Only	Percent time CGM glucose >250 mg/dL nighttime only (00:00 - 06:00)	3 months
CGM Time in Range 70-140 mg/dL Overall	Percent time CGM glucose in range 70-140 mg/dl overall	3 months
CGM Time in Range 70-140 mg/dL Daytime Only	Percent time CGM glucose in range 70-140 mg/dl daytime only (06:00 - 24:00)	3 months
CGM Time in Range 70-140 mg/dL Nighttime Only	Percent time CGM glucose in range 70-140 mg/dl nighttime only (00:00 - 06:00)	3 months
CGM Mean Glucose mg/dL Overall	CGM-measured mean glucose (mg/dL) overall	3 months
CGM Mean Glucose mg/dL Daytime Only	CGM-measured mean glucose (mg/dL) daytime only (06:00 - 24:00)	3 months
CGM Mean Glucose mg/dL Nighttime Only	CGM-measured mean glucose (mg/dL) nighttime only (00:00 - 06:00)	3 months
Coefficient of Variation Overall	CGM measured glucose variability measured with the coefficient of variation overall	3 months
Coefficient of Variation Daytime Only	CGM measured glucose variability measured with the coefficient of variation daytime only (06:00 - 24:00)	3 months
Coefficient of Variation Nighttime Only	CGM measured glucose variability measured with the coefficient of variation nighttime only (00:00 - 06:00)	3 months
Standard Deviation of Glucose, Overall	CGM measured standard deviation of glucose (mg/dL) overall	3 months
Standard Deviation of Glucose, Daytime	CGM measured standard deviation of glucose (mg/dL), daytime only (06:00 - 24:00)	3 months
Standard Deviation of Glucose, Nighttime Only	CGM measured standard deviation of glucose (mg/dL), nighttime only (00:00 - 06:00)	3 months

Collaborators and Investigators

• Sponsor: Tandem Diabetes Care, Inc.
• Investigators: Study Director: Jordan Pinsker, MD, Tandem Diabetes Care

Publications and helpful links

General Publications

• Carlson AL, Graham TE, Akturk HK, Liljenquist DR, Bergenstal RM, Sulik B, Shah VN, Sulik M, Zhao P, Briggs P, Sassan-Katchalski R, Pinsker JE. Control-IQ Technology Use in Individuals With High Insulin Requirements: Results From the Multicenter Higher-IQ Trial. J Diabetes Sci Technol. 2024 Nov;18(6):1288-1292. doi: 10.1177/19322968241234072. Epub 2024 Mar 5.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): January 6, 2023
• Study Completion (Actual): January 6, 2023

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: type 1 diabetes; Control-IQ; t:slim X2
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin
• Other Study ID Numbers: TP-0009856

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