search
Back to results

Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6
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 focused on measuring Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 2 and < 6 years old at the time of consent
  2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months and using insulin at the time of enrollment
  3. Use of an insulin pump in the past 3 months
  4. Use of Dexcom G6 for at least 11 out of the last 14 days
  5. Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses
  6. Living with one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
  7. At least one parent/guardian is willing to stay with the child during the hotel/house portion of the study on the dates selected by the study team
  8. Investigator has confidence that the parent/guardian(s) can successfully operate all study devices and is capable of adhering to the protocol
  9. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
  10. Total daily insulin dose (TDD) of at least 5 U/day
  11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
  12. Child participant and parent/guardian(s) willingness to participate in all training sessions as directed by study staff
  13. Willingness to discontinue non-Tandem t:slim insulin pumps during the entire study
  14. Willingness to wear a Dexcom G6 sensor during the entire study
  15. An understanding and willingness to follow the protocol and sign informed consent

Exclusion Criteria:

  1. Hypoglycemia induced seizure or loss of consciousness in the past 3 months
  2. Diabetes Ketoacidosis in the past 3 months
  3. Use of diluted insulin
  4. Concurrent use of any non-insulin glucose-lowering agent
  5. Hemophilia or any other bleeding disorder

  6. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. These conditions may include:

    • Acute illness at the time of the enrollment visit (fever of 101 or higher, vomiting, diarrhea)
    • Addison's disease
    • Diagnosed at less than 1 year of age without positive antibodies
    • Decreased renal function
    • Cystic fibrosis
    • Other chronic conditions, such as an underlying seizure disorder
  7. Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
  8. Having a family member(s) 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

  • Stanford University
  • Barbara Davis Center, University of Colorado
  • University of Virginia Center for Diabetes Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artificial Pancreas Therapy

Arm Description

Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.

Outcomes

Primary Outcome Measures

Primary Outcome
Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL.

Secondary Outcome Measures

Below 70 mg/dl.
Percent of time spent below 70 mg/dl.
Below 60 mg/dl.
Percent of time spent below 60mg/dl.
Below 54 mg/dl.
Percent of time spent below 54mg/dL.
Below 50mg/dl.
Percent of time spent below 50mg/dL.
Above 180 mg/dl.
Percent of time spent above 180mg/dl.
Above 250mg/dl.
Percent of time spent above 250mg/dl.
Above 300 mg/dl.
Percent of time spent above 300 mg/dl.
Between 70-140mg/dl.
Percent of time spent between 70 mg/dl and 140mg/dl.
Between 70-180mg/dl
Percent of time spent between 70 mg/dl and 180mg/dl.
Number of Hypoglycemia Below 70 mg/dL
Number of hypoglycemia events (below 70 mg/dL).
Average Number of Treatments.
Average number of carbohydrate treatments per day. Participants were treated with ~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was<80mg/dL after ~20min. Hypoglycemic treatments could occur at any time per study physician request
Average of Carbohydrate Treatments (g).
Average amount of carbohydrates (grams) used as a treatment. Participants were treated with ~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was<80mg/dL after ~20min. Hypoglycemic treatments could occur at any time per study physician request
Percent of Time Spent in Closed Loop
Percentage of the amount of time spent with the Control-IQ system running in closed loop mode.
CGM Consensus Goal
Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/dL.

Full Information

First Posted
September 6, 2019
Last Updated
March 20, 2023
Sponsor
University of Virginia
Collaborators
DexCom, Inc., Tandem Diabetes Care, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04084171
Brief Title
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
Official Title
Safety of the Tandem t:Slim X2 With Control-IQ Automated Insulin Delivery System in Preschoolers, Age 2-6 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
October 23, 2019 (Actual)
Study Completion Date
October 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
DexCom, Inc., 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 single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition
Detailed Description
This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting for the treatment of type 1 diabetes (T1D) in young children (2-6 years old).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artificial Pancreas Therapy
Arm Type
Experimental
Arm Description
Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Intervention Type
Device
Intervention Name(s)
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6
Other Intervention Name(s)
Artificial Pancreas, Automated Insulin Delivery Device
Intervention Description
Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor [CGM].
Primary Outcome Measure Information:
Title
Primary Outcome
Description
Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL.
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Secondary Outcome Measure Information:
Title
Below 70 mg/dl.
Description
Percent of time spent below 70 mg/dl.
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Title
Below 60 mg/dl.
Description
Percent of time spent below 60mg/dl.
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Title
Below 54 mg/dl.
Description
Percent of time spent below 54mg/dL.
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Title
Below 50mg/dl.
Description
Percent of time spent below 50mg/dL.
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Title
Above 180 mg/dl.
Description
Percent of time spent above 180mg/dl.
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Title
Above 250mg/dl.
Description
Percent of time spent above 250mg/dl.
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Title
Above 300 mg/dl.
Description
Percent of time spent above 300 mg/dl.
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Title
Between 70-140mg/dl.
Description
Percent of time spent between 70 mg/dl and 140mg/dl.
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Title
Between 70-180mg/dl
Description
Percent of time spent between 70 mg/dl and 180mg/dl.
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Title
Number of Hypoglycemia Below 70 mg/dL
Description
Number of hypoglycemia events (below 70 mg/dL).
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Title
Average Number of Treatments.
Description
Average number of carbohydrate treatments per day. Participants were treated with ~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was<80mg/dL after ~20min. Hypoglycemic treatments could occur at any time per study physician request
Time Frame
The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
Title
Average of Carbohydrate Treatments (g).
Description
Average amount of carbohydrates (grams) used as a treatment. Participants were treated with ~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was<80mg/dL after ~20min. Hypoglycemic treatments could occur at any time per study physician request
Time Frame
The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
Title
Percent of Time Spent in Closed Loop
Description
Percentage of the amount of time spent with the Control-IQ system running in closed loop mode.
Time Frame
The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
Title
CGM Consensus Goal
Description
Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/dL.
Time Frame
Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 2 and < 6 years old at the time of consent Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months and using insulin at the time of enrollment Use of an insulin pump in the past 3 months Use of Dexcom G6 for at least 11 out of the last 14 days Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses Living with one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff At least one parent/guardian is willing to stay with the child during the hotel/house portion of the study on the dates selected by the study team Investigator has confidence that the parent/guardian(s) can successfully operate all study devices and is capable of adhering to the protocol Willingness to switch to lispro (Humalog) or aspart (Novolog) if not already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study Total daily insulin dose (TDD) of at least 5 U/day Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial Child participant and parent/guardian(s) willingness to participate in all training sessions as directed by study staff Willingness to discontinue non-Tandem t:slim insulin pumps during the entire study Willingness to wear a Dexcom G6 sensor during the entire study An understanding and willingness to follow the protocol and sign informed consent Exclusion Criteria: Hypoglycemia induced seizure or loss of consciousness in the past 3 months Diabetes Ketoacidosis in the past 3 months Use of diluted insulin Concurrent use of any non-insulin glucose-lowering agent Hemophilia or any other bleeding disorder A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. These conditions may include: Acute illness at the time of the enrollment visit (fever of 101 or higher, vomiting, diarrhea) Addison's disease Diagnosed at less than 1 year of age without positive antibodies Decreased renal function Cystic fibrosis Other chronic conditions, such as an underlying seizure disorder Participation in another pharmaceutical or device trial at the time of enrollment or during the study. Having a family member(s) 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
Marc Breton, PhD
Organizational Affiliation
University of Virginia Center for Diabetes Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Barbara Davis Center, University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
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
To be determined
IPD Sharing Time Frame
After manuscript publication
Citations:
PubMed Identifier
33226837
Citation
Ekhlaspour L, Schoelwer MJ, Forlenza GP, DeBoer MD, Norlander L, Hsu L, Kingman R, Boranian E, Berget C, Emory E, Buckingham BA, Breton MD, Wadwa RP. Safety and Performance of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery System in Toddlers and Preschoolers. Diabetes Technol Ther. 2021 May;23(5):384-391. doi: 10.1089/dia.2020.0507. Epub 2020 Dec 8.
Results Reference
result

Learn more about this trial

Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6

We'll reach out to this number within 24 hrs