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Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
t:slim X2 insulin pump with Control-IQ technology 2.0
Sponsored by
Tandem Diabetes Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Control-IQ technology, type 1 diabetes

Eligibility Criteria

2 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 2 to ≤ 81 years Diagnosis of type 1 diabetes for at least 1 year, or at least 6 months for age 2-5 years at enrollment Prior Dexcom CGM user, with at least 11 of the prior 14 days of CGM use available for download at the screening visit to confirm eligibility Total Daily Insulin Dose (TDD) at least 2 units/day Weight ≥ 20 lbs HbA1c ≤ 10.5% For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia, present with the participant during and after the meal challenges, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. For participants ≥18 years old, availability of a local contact who has access to the study participant, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. If the participant lives alone, the local contact must live within 30 minutes and have access to the subject overnight. Investigator has confidence that the participant and/or parent/guardian can successfully operate all study devices and is capable of adhering to the protocol. Willing to use only aspart (novolog) or lispro (humalog) insulin with the study devices, with no use of long-acting basal insulin injections, or inhaled insulin with the study devices. Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one) Willing and able to perform study meal challenges. 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 For Female: Currently pregnant or planning to become pregnant during the time period of study participation A negative pregnancy test will be required for all females of child-bearing potential Counseling on appropriate birth control options will be provided to all females of child-bearing potential Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). Hemophilia or any other bleeding disorder Hemoglobinopathy 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 any medications determined by investigator to interfere with study Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea 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 (Pediatric Clinic)Recruiting
  • Barbara Davis CenterRecruiting
  • Joslin Diabetes CenterRecruiting
  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control-IQ 2.0 Alternate Target

Control-IQ 2.0 Standard Target

Arm Description

Participants will use t:slim X2 pump with Control-IQ technology 2.0 at an alternate target for two weeks.

Participants will use t:slim X2 pump with Control-IQ technology 2.0 at a standard target for two weeks.

Outcomes

Primary Outcome Measures

Number of severe hypoglycemic events
Number of severe hypoglycemic events (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
Number of diabetic ketoacidosis (DKA) events
Number of diabetic ketoacidosis during study compared with data on DKA events, compared with data on DKA events reported by T1D Exchange clinic registry over a 3-month time period
Number of unanticipated adverse device effects (UADEs)
Number of unanticipated adverse device effects during the study.
Number of other serious device-related adverse events
Number of serious device-related adverse events during the study.

Secondary Outcome Measures

All device-related adverse events
Number of device-related adverse events
Percent of time <54 mg/dL
CGM percent time <54 mg/dL during each study period.
Percent of time <70 mg/dL
CGM percent time <70 mg/dL during each study period.
Percent time 70-180 mg/dL
CGM percent time 70-180 mg/dL during each study period.
Percent time > 180 mg/dL
CGM percent time >180 mg/dL during each study period.
Percent time > 250 mg/dL
CGM percent time >250 mg/dL during each study period.
Percent time 70-140 mg/dL
CGM percent time 70-140 mg/dL during each study period.
Mean glucose
Mean CGM glucose mg/dL during each study period.
Coefficient of variation
Coefficient of variation mg/dL during each study period.
Standard deviation
Standard deviation mg/dL during each study period.
CGM metrics for time in range by time of day
CGM metrics for time in range for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM) for each study period.
Time to intervention for study meal challenges
Number of minutes until additional treatment given during study meal challenges for each study period.
Number of interventions for study meal challenges
Number of additional treatments given during study meal challenges for each study period.

Full Information

First Posted
January 5, 2023
Last Updated
July 13, 2023
Sponsor
Tandem Diabetes Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05683392
Brief Title
Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes
Official Title
Control-IQ 2.0 Feasibility Study #2: Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

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 goal of this clinical trial is to assess safety of and explore glycemic outcomes with Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes.
Detailed Description
This feasibility study is a prospective, randomized, two-period crossover multi-center study of Control-IQ technology 2.0. After a two week run-in period, the automated insulin dosing (AID) system will be evaluated in multiple age groups over 4 weeks of use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Control-IQ technology, type 1 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control-IQ 2.0 Alternate Target
Arm Type
Experimental
Arm Description
Participants will use t:slim X2 pump with Control-IQ technology 2.0 at an alternate target for two weeks.
Arm Title
Control-IQ 2.0 Standard Target
Arm Type
Experimental
Arm Description
Participants will use t:slim X2 pump with Control-IQ technology 2.0 at a standard target for two weeks.
Intervention Type
Device
Intervention Name(s)
t:slim X2 insulin pump with Control-IQ technology 2.0
Intervention Description
t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor.
Primary Outcome Measure Information:
Title
Number of severe hypoglycemic events
Description
Number of severe hypoglycemic events (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
6 weeks
Title
Number of diabetic ketoacidosis (DKA) events
Description
Number of diabetic ketoacidosis during study compared with data on DKA events, compared with data on DKA events reported by T1D Exchange clinic registry over a 3-month time period
Time Frame
6 weeks
Title
Number of unanticipated adverse device effects (UADEs)
Description
Number of unanticipated adverse device effects during the study.
Time Frame
6 weeks
Title
Number of other serious device-related adverse events
Description
Number of serious device-related adverse events during the study.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
All device-related adverse events
Description
Number of device-related adverse events
Time Frame
6 weeks
Title
Percent of time <54 mg/dL
Description
CGM percent time <54 mg/dL during each study period.
Time Frame
6 weeks
Title
Percent of time <70 mg/dL
Description
CGM percent time <70 mg/dL during each study period.
Time Frame
6 weeks
Title
Percent time 70-180 mg/dL
Description
CGM percent time 70-180 mg/dL during each study period.
Time Frame
6 weeks
Title
Percent time > 180 mg/dL
Description
CGM percent time >180 mg/dL during each study period.
Time Frame
6 weeks
Title
Percent time > 250 mg/dL
Description
CGM percent time >250 mg/dL during each study period.
Time Frame
6 weeks
Title
Percent time 70-140 mg/dL
Description
CGM percent time 70-140 mg/dL during each study period.
Time Frame
6 weeks
Title
Mean glucose
Description
Mean CGM glucose mg/dL during each study period.
Time Frame
6 weeks
Title
Coefficient of variation
Description
Coefficient of variation mg/dL during each study period.
Time Frame
6 weeks
Title
Standard deviation
Description
Standard deviation mg/dL during each study period.
Time Frame
6 weeks
Title
CGM metrics for time in range by time of day
Description
CGM metrics for time in range for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM) for each study period.
Time Frame
6 weeks
Title
Time to intervention for study meal challenges
Description
Number of minutes until additional treatment given during study meal challenges for each study period.
Time Frame
6 weeks
Title
Number of interventions for study meal challenges
Description
Number of additional treatments given during study meal challenges for each study period.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 2 to ≤ 81 years Diagnosis of type 1 diabetes for at least 1 year, or at least 6 months for age 2-5 years at enrollment Prior Dexcom CGM user, with at least 11 of the prior 14 days of CGM use available for download at the screening visit to confirm eligibility Total Daily Insulin Dose (TDD) at least 2 units/day Weight ≥ 20 lbs HbA1c ≤ 10.5% For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia, present with the participant during and after the meal challenges, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. For participants ≥18 years old, availability of a local contact who has access to the study participant, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. If the participant lives alone, the local contact must live within 30 minutes and have access to the subject overnight. Investigator has confidence that the participant and/or parent/guardian can successfully operate all study devices and is capable of adhering to the protocol. Willing to use only aspart (novolog) or lispro (humalog) insulin with the study devices, with no use of long-acting basal insulin injections, or inhaled insulin with the study devices. Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one) Willing and able to perform study meal challenges. 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 For Female: Currently pregnant or planning to become pregnant during the time period of study participation A negative pregnancy test will be required for all females of child-bearing potential Counseling on appropriate birth control options will be provided to all females of child-bearing potential Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). Hemophilia or any other bleeding disorder Hemoglobinopathy 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 any medications determined by investigator to interfere with study Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea 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, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Barbara Davis Center (Pediatric Clinic)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Geiser
Phone
303-724-2323
Email
luke.geiser@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Gregory Forlenza, MD, PhD
Facility Name
Barbara Davis Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darya Wodetski
Phone
303-724-1868
Email
darya.wodetzki@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Kaan Halis Akturk, MD
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Ambler-Osborn
Phone
617-732-2603
Email
louise.ambler-osborn@joslin.harvard.edu
First Name & Middle Initial & Last Name & Degree
Lori Laffel, MD, MPH
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianna Smith, CRC
Phone
434-284-0893
Email
lhs7px@uvahealth.org
First Name & Middle Initial & Last Name & Degree
Sue Brown, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

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