Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
t:slim X2 insulin pump with Control-IQ technology 1.5
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
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
Sites / Locations
- Barbara Davis Center
- Rocky Mountain Diabetes Center
- International Diabetes Center
- Diabetes & Endocrine Treatment Specialists
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
t:slim X2 insulin pump with Control-IQ technology
Arm Description
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.
Outcomes
Primary Outcome Measures
Severe Hypoglycemic Events
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
DKA event rate
Adverse device effects
Number of unanticipated adverse device effects
Other serious adverse events
Number of other serious adverse events
Secondary Outcome Measures
Adverse events
Number of Adverse events
Glucose < 54 mg/dL
Percent time CGM glucose < 54 mg/dL
Glucose < 70 mg/dL
Percent time CGM glucose < 70 mg/dL
Full Information
NCT ID
NCT05422053
First Posted
June 13, 2022
Last Updated
January 18, 2023
Sponsor
Tandem Diabetes Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05422053
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
January 6, 2023 (Actual)
Study Completion Date
January 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tandem Diabetes Care, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
t:slim X2 insulin pump with Control-IQ technology
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
t:slim X2 insulin pump with Control-IQ technology 1.5
Intervention Description
t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
Primary Outcome Measure Information:
Title
Severe Hypoglycemic Events
Description
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
Time Frame
3 months
Title
Diabetic ketoacidosis
Description
DKA event rate
Time Frame
3 months
Title
Adverse device effects
Description
Number of unanticipated adverse device effects
Time Frame
3 months
Title
Other serious adverse events
Description
Number of other serious adverse events
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Adverse events
Description
Number of Adverse events
Time Frame
3 months
Title
Glucose < 54 mg/dL
Description
Percent time CGM glucose < 54 mg/dL
Time Frame
3 months
Title
Glucose < 70 mg/dL
Description
Percent time CGM glucose < 70 mg/dL
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Glucose time in range 70-180 mg/dL
Description
Percent time CGM glucose in range 70-180 mg/dl
Time Frame
3 months
Title
Glucose > 180 mg/dL
Description
Percent time CGM glucose > 180 mg/dL
Time Frame
3 months
Title
Glucose > 250 mg/dL
Description
Percent time CGM glucose > 250 mg/dL
Time Frame
3 months
Title
Glucose time in range 70-140 mg/dL
Description
Percent time CGM glucose in range 70-140 mg/dl
Time Frame
3 months
Title
CGM mean glucose
Description
CGM-measured mean glucose (mg/dL)
Time Frame
3 months
Title
Coefficient of Variation
Description
CGM measured glucose variability measured with the coefficient of variation (mg/dL)
Time Frame
3 months
Title
Standard Deviation
Description
CGM measured glucose variability measured with the standard deviation (mg/dL)
Time Frame
3 months
Title
Hemoglobin A1c
Description
Change in Hemoglobin A1c from baseline
Time Frame
3 months
Title
CGM Metrics by Time of Day
Description
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)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Pinsker, MD
Organizational Affiliation
Tandem Diabetes Care
Official's Role
Study Director
Facility Information:
Facility Name
Barbara Davis Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Diabetes Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
International Diabetes Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Diabetes & Endocrine Treatment Specialists
City
Sandy
State/Province
Utah
ZIP/Postal Code
84093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ)
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