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

• ClinicalTrials.gov Identifier: NCT05422053
• Recruitment Status: Completed
• First Posted: June 16, 2022
• Last Update Posted: January 19, 2023
• Sponsor: Tandem Diabetes Care, Inc.
• Information provided by (Responsible Party): Tandem Diabetes Care, Inc.

Tracking Information

• First Submitted Date: June 13, 2022
• First Posted Date: June 16, 2022
• Last Update Posted Date: January 19, 2023
• Actual Study Start Date: June 29, 2022
• Actual Primary Completion Date: January 6, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 13, 2022)

• Severe Hypoglycemic Events [ Time Frame: 3 months ]
  Severe hypoglycemia (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry over a 3-month time period
• Diabetic ketoacidosis [ Time Frame: 3 months ]
  DKA event rate
• Adverse device effects [ Time Frame: 3 months ]
  Number of unanticipated adverse device effects
• Other serious adverse events [ Time Frame: 3 months ]
  Number of other serious adverse events

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 13, 2022)

• Adverse events [ Time Frame: 3 months ]
  Number of Adverse events
• Glucose < 54 mg/dL [ Time Frame: 3 months ]
  Percent time CGM glucose < 54 mg/dL
• Glucose < 70 mg/dL [ Time Frame: 3 months ]
  Percent time CGM glucose < 70 mg/dL

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 13, 2022)

• Glucose time in range 70-180 mg/dL [ Time Frame: 3 months ]
  Percent time CGM glucose in range 70-180 mg/dl
• Glucose > 180 mg/dL [ Time Frame: 3 months ]
  Percent time CGM glucose > 180 mg/dL
• Glucose > 250 mg/dL [ Time Frame: 3 months ]
  Percent time CGM glucose > 250 mg/dL
• Glucose time in range 70-140 mg/dL [ Time Frame: 3 months ]
  Percent time CGM glucose in range 70-140 mg/dl
• CGM mean glucose [ Time Frame: 3 months ]
  CGM-measured mean glucose (mg/dL)
• Coefficient of Variation [ Time Frame: 3 months ]
  CGM measured glucose variability measured with the coefficient of variation (mg/dL)
• Standard Deviation [ Time Frame: 3 months ]
  CGM measured glucose variability measured with the standard deviation (mg/dL)
• Hemoglobin A1c [ Time Frame: 3 months ]
  Change in Hemoglobin A1c from baseline
• CGM Metrics by Time of Day [ Time Frame: 3 months ]
  All CGM metrics listed above (percent time) for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM)

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ)
• Official Title: Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ)
• 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type 1 Diabetes

Intervention

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.

Study Arms

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.

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 18, 2023): 34
• Original Estimated Enrollment (submitted: June 13, 2022): 60
• Actual Study Completion Date: January 6, 2023
• Actual Primary Completion Date: January 6, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05422053
• Other Study ID Numbers: TP-0009856
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Tandem Diabetes Care, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Tandem Diabetes Care, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jordan Pinsker, MD; Tandem Diabetes Care

• PRS Account: Tandem Diabetes Care, Inc.
• Verification Date: January 2023