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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05422053
• Other study ID #: TP-0009856
• Status: Completed
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: January 6, 2023

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 6, 2023
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• 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.

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado
United States	Rocky Mountain Diabetes Center	Idaho Falls	Idaho
United States	International Diabetes Center	Minneapolis	Minnesota
United States	Diabetes & Endocrine Treatment Specialists	Sandy	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Tandem Diabetes Care, Inc.

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin A1c	Change in Hemoglobin A1c from baseline	3 months
Other	CGM Time in Range 70-180 mg/dL Overall	Percent time CGM glucose in range 70-180 mg/dl overall	3 months
Other	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
Other	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
Other	CGM Time >180 mg/dL Overall	Percent time CGM glucose> 180 mg/dL overall	3 months
Other	CGM Time >180 mg/dL Daytime Only	Percent time CGM glucose> 180 mg/dL daytime only (06:00 - 24:00)	3 months
Other	CGM Time >180 mg/dL Nighttime Only	Percent time CGM glucose> 180 mg/dL nighttime only (00:00 - 06:00)	3 months
Other	CGM Time >250 mg/dL Overall	Percent time CGM glucose >250 mg/dL overall	3 months
Other	CGM Time >250 mg/dL Daytime Only	Percent time CGM glucose >250 mg/dL daytime only (06:00 - 24:00)	3 months
Other	CGM Time >250 mg/dL Nighttime Only	Percent time CGM glucose >250 mg/dL nighttime only (00:00 - 06:00)	3 months
Other	CGM Time in Range 70-140 mg/dL Overall	Percent time CGM glucose in range 70-140 mg/dl overall	3 months
Other	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
Other	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
Other	CGM Mean Glucose mg/dL Overall	CGM-measured mean glucose (mg/dL) overall	3 months
Other	CGM Mean Glucose mg/dL Daytime Only	CGM-measured mean glucose (mg/dL) daytime only (06:00 - 24:00)	3 months
Other	CGM Mean Glucose mg/dL Nighttime Only	CGM-measured mean glucose (mg/dL) nighttime only (00:00 - 06:00)	3 months
Other	Coefficient of Variation Overall	CGM measured glucose variability measured with the coefficient of variation overall	3 months
Other	Coefficient of Variation Daytime Only	CGM measured glucose variability measured with the coefficient of variation daytime only (06:00 - 24:00)	3 months
Other	Coefficient of Variation Nighttime Only	CGM measured glucose variability measured with the coefficient of variation nighttime only (00:00 - 06:00)	3 months
Other	Standard Deviation of Glucose, Overall	CGM measured standard deviation of glucose (mg/dL) overall	3 months
Other	Standard Deviation of Glucose, Daytime	CGM measured standard deviation of glucose (mg/dL), daytime only (06:00 - 24:00)	3 months
Other	Standard Deviation of Glucose, Nighttime Only	CGM measured standard deviation of glucose (mg/dL), nighttime only (00:00 - 06:00)	3 months
Primary	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
Primary	Number of Diabetic Ketoacidosis Events	Number of diabetic ketoacidosis events during the entire study period	3 months
Primary	Unanticipated Adverse Device Effects	Number of unanticipated adverse device effects during the entire study period	3 months
Primary	Other Serious Adverse Events	Number of serious adverse events during the entire study period	3 months
Secondary	CGM Time <54 mg/dL Overall	Percent time CGM glucose <54 mg/dL overall	3 months
Secondary	CGM Time <54 mg/dL Daytime Only	Percent time CGM glucose <54 mg/dL daytime only (06:00 - 24:00)	3 months
Secondary	CGM Time <54 mg/dL Nighttime Only	Percent time CGM glucose <54 mg/dL nighttime only (00:00 - 06:00)	3 months
Secondary	CGM Time <70 mg/dL Overall	Percent time CGM glucose <70 mg/dL overall	3 months
Secondary	CGM Time <70 mg/dL Daytime Only	Percent time CGM glucose <70 mg/dL daytime only (06:00 - 24:00)	3 months
Secondary	CGM Time <70 mg/dL Nighttime Only	Percent time CGM glucose <70 mg/dL nighttime only (00:00 - 06:00)	3 months