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Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hybrid Closed Loop (HCL)
Control-IQ with MyTDI
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Artificial Pancreas (AP), Insulin Pump, Continuous Glucose Monitor (CGM), MyTDI, Hybrid Closed Loop (HCL), Total Daily Insulin (TDI)

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Criteria for documented hyperglycemia (at least 1 must be met):

    • Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required)
    • Diagnosis of type 1 diabetes is based on the investigator's judgement

  • Criteria for requiring insulin at diagnosis (both criteria must be met):

    • Daily insulin therapy for ≥ 6 months
    • Insulin pump therapy for ≥ 3 months
  • Age 12-18 years
  • Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or aspart.
  • Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month.
  • Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study.
  • For females, not pregnant or breastfeeding. Female subjects who are sexually active should agree to use birth control during the study.
  • Total daily insulin dose (TDD) at least 10 U/day.

Exclusion Criteria:

  • Diabetic ketoacidosis in the past 6 months
  • Hypoglycemic seizure or loss of consciousness in the past 6 months
  • History of seizure disorder
  • History of any heart disease including coronary artery disease, heart failure, or arrhythmias
  • History of altitude sickness
  • Chronic pulmonary conditions that could impair oxygenation
  • Cystic fibrosis
  • Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgement of the investigator, would be a contraindication to participation in the study.
  • History of ongoing renal disease (other than microalbuminuria).
  • Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir, or Glargine).
  • Pregnancy
  • Presence of a febrile illness within 24 hours of the Ski Admission

  • Medical or psychiatric conditions that in the judgement of the investigator might interfere with the completion of the protocol such as:

    • Inpatient psychiatric treatment in the past 6 months
    • Uncontrolled adrenal insufficiency
    • Alcohol abuse

Sites / Locations

  • University of Virginia Center for Diabetes Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hybrid Closed Loop (HCL)

Control-IQ with MyTDI

Arm Description

Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.

Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home: A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day A single correction factor (CF) of 1650/TDI will be implemented across the whole day Carbohydrate ratios (CR) will be set at: 00:00-04:00 CR=450/TDI 04:00-11:00 CR=360/TDI 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.

Outcomes

Primary Outcome Measures

change between Percent Time in Range at home pre/post intervention at home
The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.

Secondary Outcome Measures

Change in average CGM at home
number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame.
Change in average CGM at camp
number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame.
Change in Percent CGM below 50mg/dL at home
the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent CGM below 50mg/dL at camp
the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent CGM below 54mg/dL at camp
the number of CGM values falling below 54mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent below 60mg/dL at home
the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent below 60mg/dL at camp
the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent CGM below 70mg/dL at home
the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent CGM below 70mg/dL at camp
the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent CGM between 70mg/dL and 180mg/dL at camp
the number of CGM values falling between 70mg/dL and 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent CGM above 180mg/dL at home
the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent CGM above 180mg/dL at camp
the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent CGM above 250mg/dL at home
the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent CGM above 250mg/dL at camp
the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent CGM above 300mg/dL at home
the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Percent CGM above 300mg/dL at camp
the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Change in Total daily insulin at home
sum of the recorded insulin injection over the time frame in units
Change in Total daily insulin at camp
sum of the recorded insulin injection over the time frame in units
Change in Total meal carbohydrates at home
sum of the meal sized recorded over the time frame
Change in Total meal carbohydrates at camp
sum of the meal sized recorded over the time frame
Change in Number of hypoglycemic events at home
Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)
Change in Number of hypoglycemic events at camp
Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)
Change in number of Hypoglycemia treatment at home
Sum of the number of CHO treatments recorded over the time frame
Change in number of Hypoglycemia treatment at camp
Sum of the number of CHO treatments recorded over the time frame
Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at home
Sum of the amount of carbohydrates used for treatments recorded over the time frame
Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at camp
Sum of the amount of carbohydrates used for treatments recorded over the time frame

Full Information

First Posted
January 11, 2019
Last Updated
September 28, 2020
Sponsor
University of Virginia
Collaborators
Tandem Diabetes Care, Inc., DexCom, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03804983
Brief Title
Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
Official Title
Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
February 16, 2019 (Actual)
Study Completion Date
February 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Tandem Diabetes Care, Inc., DexCom, 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 proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.
Detailed Description
This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes. Once deemed eligible, participants and their parent(s) will be trained on the use of the Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system. Participants will then use the this study equipment with their home insulin parameters at home for at home for 5 days. Participants will then come to the ski resort to participate in a 72-hour ski admission. Upon arrival, each participant will be randomized to either the using the Control-IQ system with their usual insulin parameters during the ski study and the at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and the at-home 5 days at home study. Study duration for each participant will require 5 study visits over about 2 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Artificial Pancreas (AP), Insulin Pump, Continuous Glucose Monitor (CGM), MyTDI, Hybrid Closed Loop (HCL), Total Daily Insulin (TDI)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) System t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Closed Loop (HCL)
Arm Type
Active Comparator
Arm Description
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
Arm Title
Control-IQ with MyTDI
Arm Type
Experimental
Arm Description
Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home: A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day A single correction factor (CF) of 1650/TDI will be implemented across the whole day Carbohydrate ratios (CR) will be set at: 00:00-04:00 CR=450/TDI 04:00-11:00 CR=360/TDI 11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
Intervention Type
Device
Intervention Name(s)
Hybrid Closed Loop (HCL)
Intervention Description
Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
Intervention Type
Device
Intervention Name(s)
Control-IQ with MyTDI
Intervention Description
Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
Primary Outcome Measure Information:
Title
change between Percent Time in Range at home pre/post intervention at home
Description
The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Change in average CGM at home
Description
number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame.
Time Frame
5 days
Title
Change in average CGM at camp
Description
number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame.
Time Frame
2 days
Title
Change in Percent CGM below 50mg/dL at home
Description
the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
5 days
Title
Change in Percent CGM below 50mg/dL at camp
Description
the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
5 days
Title
Change in Percent CGM below 54mg/dL at camp
Description
the number of CGM values falling below 54mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
2 days
Title
Change in Percent below 60mg/dL at home
Description
the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
5 days
Title
Change in Percent below 60mg/dL at camp
Description
the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
2 days
Title
Change in Percent CGM below 70mg/dL at home
Description
the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
5 days
Title
Change in Percent CGM below 70mg/dL at camp
Description
the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
2 days
Title
Change in Percent CGM between 70mg/dL and 180mg/dL at camp
Description
the number of CGM values falling between 70mg/dL and 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
2 days
Title
Change in Percent CGM above 180mg/dL at home
Description
the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
5 days
Title
Change in Percent CGM above 180mg/dL at camp
Description
the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
2 days
Title
Change in Percent CGM above 250mg/dL at home
Description
the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
5 days
Title
Change in Percent CGM above 250mg/dL at camp
Description
the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
5 days2
Title
Change in Percent CGM above 300mg/dL at home
Description
the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
5 days
Title
Change in Percent CGM above 300mg/dL at camp
Description
the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Time Frame
2 days
Title
Change in Total daily insulin at home
Description
sum of the recorded insulin injection over the time frame in units
Time Frame
5 days
Title
Change in Total daily insulin at camp
Description
sum of the recorded insulin injection over the time frame in units
Time Frame
2 days
Title
Change in Total meal carbohydrates at home
Description
sum of the meal sized recorded over the time frame
Time Frame
5 days
Title
Change in Total meal carbohydrates at camp
Description
sum of the meal sized recorded over the time frame
Time Frame
2 days
Title
Change in Number of hypoglycemic events at home
Description
Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)
Time Frame
5 days
Title
Change in Number of hypoglycemic events at camp
Description
Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)
Time Frame
2 days
Title
Change in number of Hypoglycemia treatment at home
Description
Sum of the number of CHO treatments recorded over the time frame
Time Frame
5 days
Title
Change in number of Hypoglycemia treatment at camp
Description
Sum of the number of CHO treatments recorded over the time frame
Time Frame
2 days
Title
Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at home
Description
Sum of the amount of carbohydrates used for treatments recorded over the time frame
Time Frame
5 days
Title
Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at camp
Description
Sum of the amount of carbohydrates used for treatments recorded over the time frame
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Criteria for documented hyperglycemia (at least 1 must be met): Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required) Diagnosis of type 1 diabetes is based on the investigator's judgement Criteria for requiring insulin at diagnosis (both criteria must be met): Daily insulin therapy for ≥ 6 months Insulin pump therapy for ≥ 3 months Age 12-18 years Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or aspart. Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month. Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study. For females, not pregnant or breastfeeding. Female subjects who are sexually active should agree to use birth control during the study. Total daily insulin dose (TDD) at least 10 U/day. Exclusion Criteria: Diabetic ketoacidosis in the past 6 months Hypoglycemic seizure or loss of consciousness in the past 6 months History of seizure disorder History of any heart disease including coronary artery disease, heart failure, or arrhythmias History of altitude sickness Chronic pulmonary conditions that could impair oxygenation Cystic fibrosis Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgement of the investigator, would be a contraindication to participation in the study. History of ongoing renal disease (other than microalbuminuria). Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir, or Glargine). Pregnancy Presence of a febrile illness within 24 hours of the Ski Admission Medical or psychiatric conditions that in the judgement of the investigator might interfere with the completion of the protocol such as: Inpatient psychiatric treatment in the past 6 months Uncontrolled adrenal insufficiency Alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc D. Breton, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Center for Diabetes Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
IPD Sharing Time Frame
Generally, data will be made available after the primary publications of each study.
IPD Sharing Access Criteria
Complete data sets will be provided to industry partners who would use the data for regulatory clearance (PMA - pre-market approval) of the tested artificial pancreas system. This will be done in response to the specific requirements of RFA-DK-14-024 for this project to "…generate data able to satisfy safety and efficacy requirements by regulatory agencies regarding the clinical testing of artificial pancreas device systems" in the target population of people with type 1 diabetes.
Citations:
PubMed Identifier
32119790
Citation
Schoelwer MJ, Robic JL, Gautier T, Fabris C, Carr K, Clancy-Oliveri M, Brown SA, Anderson SM, DeBoer MD, Chernavvsky DR, Breton MD. Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Based on Total Daily Insulin in Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2020 Aug;22(8):594-601. doi: 10.1089/dia.2019.0471. Epub 2020 Mar 2.
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Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin

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