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The Pediatric Artificial Pancreas Automated Initialization Trial (PEDAP-AI)

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AI-based Advisor system
Sponsored by
Marc Breton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Continuous Glucose Monitor (CGM), Tandem t:slim Insulin Pump with Control-IQ Technology, Control-IQ Technology (CIQ), Artificial Pancreas (AP), Artificial Intelligence (AI), Closed loop control (CLC), Diabetes Assistant (DiAs)

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months Familiarity and use of a carbohydrate ratio for meal boluses Age ≥2 and <6 years old Using a Dexcom CGM at the time of enrollment, with use on at least 21 out of the prior 28 days Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff Parent/guardian has a phone that can run the Tandem t:connect Mobile App (typically Android 10 or above or iPhone Operating System (iOS) 15 or above) Willingness to use the t:connect Mobile App as needed during the study and ensure connectivity for a data upload at least once per day Investigator has confidence that the parent 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 using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study162 provided Tandem pump during the study Total daily insulin dose (TDD) at least 5 Units/day Body weight at least 20 pounds (lbs) Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff Parent/guardian proficient in reading and writing English Live in the United States, with no plans to move outside the United States during the study period Exclusion Criteria: Currently using an insulin pump Concurrent use of any non-insulin glucose-lowering agent (including glucagon- like peptide (GLP)-1 agonists, Symlin, dipeptidyl peptidase (DPP)-4 inhibitors, sodium-glucose cotransporter (SGLT)-2 inhibitors, sulfonylureas) Hemophilia or any other bleeding disorder History of >1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months History of >1 Diabetic Ketoacidosis (DKA) event in the last 6 months not related to illness, infusion set failure, or initial diagnosis History of chronic renal disease or currently on hemodialysis History of adrenal insufficiency Hypothyroidism that is not adequately treated in the opinion of the investigator Use of oral or injectable steroids within the last 8 weeks Known, ongoing adhesive intolerance Plans to receive blood transfusions or erythropoietin injections during the course of the study 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 during the study Having immediate family members employed by Tandem Diabetes Care, Inc. or Dexcom, 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 UniversityRecruiting
  • Barbara Davis Center, University of ColoradoRecruiting
  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AI Advisor-driven at-home closed loop system initiation and parameter adaptation

Arm Description

In this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system.

Outcomes

Primary Outcome Measures

Primary Safety Endpoint (Hyperglycemia)
The percent of time spent above 250 mg/dL between the 8 weeks follow-up and baseline
Primary Safety Endpoint (Hypoglycemia)
The percent of time spent below 54 mg/dL between the 8 weeks follow-up and baseline

Secondary Outcome Measures

CGM Measured Time in Range
The percent of time spent within range, 70 mg/dL-180 mg/dL.
CGM Measured Mean Glucose
The average of the CGM values measured and collected within the 8-week data collection period.
CGM Measured Hypoglycemia
The percent of time spent below 70 mg/dL.
CGM Measured Glucose Coefficient of Variation
Observed glucose variability ((standard deviation/mean)x100)
Binary outcome 1
% Time in range 70-180 mg/dL improvement from baseline to 8 weeks ≥5%
Binary outcome 2
% Time in range 70-180 mg/dL improvement from baseline to 8 weeks ≥10%
Binary outcome 3
% Time in range 70-180 mg/dL >70% and % time <70 mg/dL <4%
Total daily insulin
Total daily insulin (units/kg)
Basal Insulin
Percentage of total insulin delivered via basal administration.

Full Information

First Posted
August 18, 2023
Last Updated
September 22, 2023
Sponsor
Marc Breton
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research, University of Colorado, Denver, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT06017089
Brief Title
The Pediatric Artificial Pancreas Automated Initialization Trial
Acronym
PEDAP-AI
Official Title
The Pediatric Artificial Pancreas Automated Initialization Trial (PEDAP-AI): A Pilot Study of AI Advisor-Driven Pump Initiation and Parameter Adaptation in Young Children With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marc Breton
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research, University of Colorado, Denver, Stanford University

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
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young children with Type 1 Diabetes. The main endpoints this study aims to answer is the safety and efficacy of the use of the AI-driven pump parameters. Participants will use the study system (pump and Continuous Glucose Monitor) in closed-loop mode for eight weeks.
Detailed Description
In this single-arm pilot study of an AI Advisor-driven closed loop system initiation and parameter adaptation in youth age 2 to <6 years old, participants will use the Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to the University of Virginia (UVA) cloud-based Physician Dashboard for eight weeks at home. The key safety outcomes are time spent below 54mg/dL and time spent above 250mg/dL compared with baseline and with a matched historical control population over the same time period from the prior PEDAP study that did not involve the use of any AI-driven pump parameters. Severe hypoglycemia and diabetic ketoacidosis episodes will also be reported. Glycemic outcomes including time in target range 70-180 mg/dL (TIR) and various other CGM measures of hypo- and hyperglycemia will be assessed and compared with baseline and the PEDAP historical control mentioned above. Up to 45 screened participants with the goal of at least 30 participants completing the study pump use period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Continuous Glucose Monitor (CGM), Tandem t:slim Insulin Pump with Control-IQ Technology, Control-IQ Technology (CIQ), Artificial Pancreas (AP), Artificial Intelligence (AI), Closed loop control (CLC), Diabetes Assistant (DiAs)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In this single-arm intervention trial, all participants will use the study system (pump and CGM) in closed-loop mode for 8 weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AI Advisor-driven at-home closed loop system initiation and parameter adaptation
Arm Type
Experimental
Arm Description
In this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system.
Intervention Type
Device
Intervention Name(s)
AI-based Advisor system
Intervention Description
Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint (Hyperglycemia)
Description
The percent of time spent above 250 mg/dL between the 8 weeks follow-up and baseline
Time Frame
8 weeks
Title
Primary Safety Endpoint (Hypoglycemia)
Description
The percent of time spent below 54 mg/dL between the 8 weeks follow-up and baseline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
CGM Measured Time in Range
Description
The percent of time spent within range, 70 mg/dL-180 mg/dL.
Time Frame
8 weeks
Title
CGM Measured Mean Glucose
Description
The average of the CGM values measured and collected within the 8-week data collection period.
Time Frame
8 weeks
Title
CGM Measured Hypoglycemia
Description
The percent of time spent below 70 mg/dL.
Time Frame
8 weeks
Title
CGM Measured Glucose Coefficient of Variation
Description
Observed glucose variability ((standard deviation/mean)x100)
Time Frame
8 weeks
Title
Binary outcome 1
Description
% Time in range 70-180 mg/dL improvement from baseline to 8 weeks ≥5%
Time Frame
8 weeks
Title
Binary outcome 2
Description
% Time in range 70-180 mg/dL improvement from baseline to 8 weeks ≥10%
Time Frame
8 weeks
Title
Binary outcome 3
Description
% Time in range 70-180 mg/dL >70% and % time <70 mg/dL <4%
Time Frame
8 weeks
Title
Total daily insulin
Description
Total daily insulin (units/kg)
Time Frame
8 weeks
Title
Basal Insulin
Description
Percentage of total insulin delivered via basal administration.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months Familiarity and use of a carbohydrate ratio for meal boluses Age ≥2 and <6 years old Using a Dexcom CGM at the time of enrollment, with use on at least 21 out of the prior 28 days Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff Parent/guardian has a phone that can run the Tandem t:connect Mobile App (typically Android 10 or above or iPhone Operating System (iOS) 15 or above) Willingness to use the t:connect Mobile App as needed during the study and ensure connectivity for a data upload at least once per day Investigator has confidence that the parent 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 using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study162 provided Tandem pump during the study Total daily insulin dose (TDD) at least 5 Units/day Body weight at least 20 pounds (lbs) Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff Parent/guardian proficient in reading and writing English Live in the United States, with no plans to move outside the United States during the study period Exclusion Criteria: Currently using an insulin pump Concurrent use of any non-insulin glucose-lowering agent (including glucagon- like peptide (GLP)-1 agonists, Symlin, dipeptidyl peptidase (DPP)-4 inhibitors, sodium-glucose cotransporter (SGLT)-2 inhibitors, sulfonylureas) Hemophilia or any other bleeding disorder History of >1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months History of >1 Diabetic Ketoacidosis (DKA) event in the last 6 months not related to illness, infusion set failure, or initial diagnosis History of chronic renal disease or currently on hemodialysis History of adrenal insufficiency Hypothyroidism that is not adequately treated in the opinion of the investigator Use of oral or injectable steroids within the last 8 weeks Known, ongoing adhesive intolerance Plans to receive blood transfusions or erythropoietin injections during the course of the study 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 during the study Having immediate family members employed by Tandem Diabetes Care, Inc. or Dexcom, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc D Breton, Ph.D.
Phone
4349826484
Email
mb6nt@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emma G Emory, RN
Phone
4342433992
Email
ee9m@uvahealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Lum, MS
Organizational Affiliation
Jaeb Center for Health Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Raj Paul Wadwa, MD
Organizational Affiliation
Barbara Davis Center, University of Colorado
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc D Breton, Ph.D.
Organizational Affiliation
University of Virginia Center for Diabetes Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Buckingham, MD
Phone
650-723-5791
Email
buckingham@stanford.edu
Facility Name
Barbara Davis Center, University of Colorado
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
Raj Paul Wadwa, MD
Email
paul.wadwa@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Raj Paul Wadwa, MD
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
Marc D Breton, Ph.D.
Phone
434-982-6484
Email
mb6nt@virginia.edu
First Name & Middle Initial & Last Name & Degree
Marc D Breton, Ph.D.
First Name & Middle Initial & Last Name & Degree
Mark D DeBoer, MD
First Name & Middle Initial & Last Name & Degree
Melissa J Schoelwer, MD

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 in the scientific community
IPD Sharing Time Frame
Data will be made available after the primary publications of each study site.
IPD Sharing Access Criteria
The Data Sharing Agreements will be formulated by the study team.

Learn more about this trial

The Pediatric Artificial Pancreas Automated Initialization Trial

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