Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control-IQ technology 2.0
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring type 1 diabetes, Control-IQ Technology, automated insulin dosing, automated insulin delivery
Eligibility Criteria
Inclusion Criteria:
- Adult and adolescent male and female subjects >age 14 years
- Clinical diagnosis of Type 1 diabetes for at least one year
- Experienced Control-IQ technology user for ≥3 months.
- Use of Control-IQ technology in closed-loop at least 80% of the 2-week time period before screening.
- Not pregnant or planning a pregnancy during the time period of the study
- Using only Humalog U-100 or Novolog U-100 insulin
- ICR and ISF optimized per investigator judgement
- CGM time in range (70-180 mg/dL) at least 50% on Control-IQ technology
- Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
Willing to:
- Share Dexcom G6 CGM data with study staff and Tandem
- Share t:connect data with Tandem
- Eat meals with known carbohydrate amounts
- Take meal boluses as directed (use of different options as scheduled and instructed)
- Follow study Glycemic Treatment Guidelines for hypo and hyperglycemia
- Keep food and exercise diary
- Set accurate sleep schedule on pump
- Exercise while using exercise activity in Control-IQ technology at least twice weekly
- Complete questionnaires before and after using investigational device
- Sign an informed consent form
- Willingness to use the Dexcom G6 app on their personal phone throughout the study, and share real time CGM information with a local contact and study staff
- Availability of a local contact who has access to the study participant, knows their whereabouts, and agrees to be promptly available if contacted by study staff. If the subject lives alone, the local contact must live within 30 minutes and have access to the subject overnight.
Exclusion Criteria:
- Diabetic ketoacidosis (DKA) in the past 6 months
- 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 is unwilling to agree to abstain from illicit drugs throughout the study
- History of heart, lung or kidney disease determined by the investigator to interfere with the study
- Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with the study
- Use of long-acting insulin or any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than metformin
- Use of Afrezza during the study period
- Febrile illness within 3 days of the start of the study
- Subject is pregnant or lactating or intending to become pregnant before or during participation in this study
- For subjects >50 years old or with diabetes duration >20 years who will be exercising as part of the 48 hour study, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms)
- Significant chronic kidney disease (eGFR < 60) or hemodialysis
- Significant liver disease
- History of adrenal insufficiency
- History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Control-IQ 2.0 technology 2.0 on the t:slim X2 insulin pump
Arm Description
Each subject will use different combinations of new features of the system each week, in random order, over the next 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0. The first 5 subjects in the study will complete a 48 hour session with multiple challenges during use of Control-IQ technology 2.0, before moving on the outpatient portion of the trial.
Outcomes
Primary Outcome Measures
Significant Hypoglycemia
CGM percent time <54 mg/dL during each week of feature use, as well as during baseline and run-in periods
Severe hypoglycemia (needing assistance)
Number of severe hypoglycemic events (per protocol) during each week of feature use, as well as during baseline and run-in periods
Diabetic Ketoacidosis
Number of participants with Diabetic Ketoacidosis (per protocol) during each week of feature use, as well as during baseline and run-in periods
Serious Adverse Events
Number of Serious Adverse Events during each week of feature use, as well as during baseline and run-in periods
Secondary Outcome Measures
Percent of time <70 mg/dL
CGM percent time <70 mg/dL during each week of feature use, as well as during baseline and run-in periods
Percent of time > 250 mg/dL
CGM percent time > 250 mg/dL during each week of feature use, as well as during baseline and run-in periods
Percent of time 70-180 mg/dL
CGM percent time in range 70-180 mg/dL during each week of feature use, as well as during baseline and run-in periods
Percent of time 70-140 mg/dL
CGM percent time in range 70-140 mg/dL, during each week of feature use, as well as during baseline and run-in periods
Postprandial glycemic peak mg/dL
Peak CGM glucose after each meal, during each week of feature use, as well as during baseline and run-in periods
CGM Metrics by time of day
Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only, and Nighttime only.
Full Information
NCT ID
NCT05014789
First Posted
August 13, 2021
Last Updated
January 10, 2022
Sponsor
Tandem Diabetes Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05014789
Brief Title
Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study
Official Title
A Control-IQ Technology 2.0 Feasibility Study in Adult and Adolescent Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (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
The purpose of this study is to obtain preliminary safety and performance data on planned improvements to Control-IQ technology.
Detailed Description
This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by a 48-hour supervised phase, followed by a 4-week at home study with sequential interventions (new feature use). Approximately 30 subjects, both male and female, aged 14 and up, will participate in the study, using new features each week with the t:slim X2 insulin pump with Control-IQ technology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
type 1 diabetes, Control-IQ Technology, automated insulin dosing, automated insulin delivery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm, Single Center, Prospective Clinical Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control-IQ 2.0 technology 2.0 on the t:slim X2 insulin pump
Arm Type
Experimental
Arm Description
Each subject will use different combinations of new features of the system each week, in random order, over the next 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
The first 5 subjects in the study will complete a 48 hour session with multiple challenges during use of Control-IQ technology 2.0, before moving on the outpatient portion of the trial.
Intervention Type
Device
Intervention Name(s)
Control-IQ technology 2.0
Intervention Description
All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor
Primary Outcome Measure Information:
Title
Significant Hypoglycemia
Description
CGM percent time <54 mg/dL during each week of feature use, as well as during baseline and run-in periods
Time Frame
8 weeks
Title
Severe hypoglycemia (needing assistance)
Description
Number of severe hypoglycemic events (per protocol) during each week of feature use, as well as during baseline and run-in periods
Time Frame
8 weeks
Title
Diabetic Ketoacidosis
Description
Number of participants with Diabetic Ketoacidosis (per protocol) during each week of feature use, as well as during baseline and run-in periods
Time Frame
8 weeks
Title
Serious Adverse Events
Description
Number of Serious Adverse Events during each week of feature use, as well as during baseline and run-in periods
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Percent of time <70 mg/dL
Description
CGM percent time <70 mg/dL during each week of feature use, as well as during baseline and run-in periods
Time Frame
8 weeks
Title
Percent of time > 250 mg/dL
Description
CGM percent time > 250 mg/dL during each week of feature use, as well as during baseline and run-in periods
Time Frame
8 weeks
Title
Percent of time 70-180 mg/dL
Description
CGM percent time in range 70-180 mg/dL during each week of feature use, as well as during baseline and run-in periods
Time Frame
8 weeks
Title
Percent of time 70-140 mg/dL
Description
CGM percent time in range 70-140 mg/dL, during each week of feature use, as well as during baseline and run-in periods
Time Frame
8 weeks
Title
Postprandial glycemic peak mg/dL
Description
Peak CGM glucose after each meal, during each week of feature use, as well as during baseline and run-in periods
Time Frame
8 weeks
Title
CGM Metrics by time of day
Description
Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only, and Nighttime only.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult and adolescent male and female subjects >age 14 years
Clinical diagnosis of Type 1 diabetes for at least one year
Experienced Control-IQ technology user for ≥3 months.
Use of Control-IQ technology in closed-loop at least 80% of the 2-week time period before screening.
Not pregnant or planning a pregnancy during the time period of the study
Using only Humalog U-100 or Novolog U-100 insulin
ICR and ISF optimized per investigator judgement
CGM time in range (70-180 mg/dL) at least 50% on Control-IQ technology
Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
Willing to:
Share Dexcom G6 CGM data with study staff and Tandem
Share t:connect data with Tandem
Eat meals with known carbohydrate amounts
Take meal boluses as directed (use of different options as scheduled and instructed)
Follow study Glycemic Treatment Guidelines for hypo and hyperglycemia
Keep food and exercise diary
Set accurate sleep schedule on pump
Exercise while using exercise activity in Control-IQ technology at least twice weekly
Complete questionnaires before and after using investigational device
Sign an informed consent form
Willingness to use the Dexcom G6 app on their personal phone throughout the study, and share real time CGM information with a local contact and study staff
Availability of a local contact who has access to the study participant, knows their whereabouts, and agrees to be promptly available if contacted by study staff. If the subject lives alone, the local contact must live within 30 minutes and have access to the subject overnight.
Exclusion Criteria:
Diabetic ketoacidosis (DKA) in the past 6 months
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 is unwilling to agree to abstain from illicit drugs throughout the study
History of heart, lung or kidney disease determined by the investigator to interfere with the study
Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with the study
Use of long-acting insulin or any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than metformin
Use of Afrezza during the study period
Febrile illness within 3 days of the start of the study
Subject is pregnant or lactating or intending to become pregnant before or during participation in this study
For subjects >50 years old or with diabetes duration >20 years who will be exercising as part of the 48 hour study, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms)
Significant chronic kidney disease (eGFR < 60) or hemodialysis
Significant liver disease
History of adrenal insufficiency
History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan E Pinsker, MD
Organizational Affiliation
Tandem Diabetes Care, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study
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