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

NCT05422053 | Completed Results FDA Device

• 1 other identifier: TP-0009856
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Control-IQ; type 1 diabetes; t:slim X2

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• CGM Time <54 mg/dL Overall

  3 months

• CGM Time <54 mg/dL Daytime Only

  3 months

• CGM Time <54 mg/dL Nighttime Only

  3 months

• CGM Time <70 mg/dL Overall

  3 months

• CGM Time <70 mg/dL Daytime Only

  3 months

Other Outcomes (22)

• Hemoglobin A1c

  3 months

• CGM Time in Range 70-180 mg/dL Overall

  3 months

• CGM Time in Range 70-180 mg/dL Daytime Only

  3 months

Study Arms (1)

t:slim X2 insulin pump with Control-IQ technology

EXPERIMENTAL

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

Interventions

t:slim X2 insulin pump with Control-IQ technology 1.5 DEVICE

t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.

t:slim X2 insulin pump with Control-IQ technology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead

Study Sites (4)

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Diabetes Center

Idaho Falls, Idaho, 83404, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Diabetes & Endocrine Treatment Specialists

Sandy City, Utah, 84093, United States

Location

Related Publications (1)

• 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.

  PMID: 38439656 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Supervisor, Clinical Operations
• Organization: Tandem Diabetes Care

clinicalaffairs@tandemdiabetes.com

(858) 366-6900

Study Officials

• Jordan Pinsker, MD

  Tandem Diabetes Care

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: June 29, 2022
• Primary Completion: January 6, 2023
• Study Completion: January 6, 2023
• Last Updated: April 3, 2025
• Results First Posted: April 17, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)