The Pediatric Artificial Pancreas Automated Initialization Trial

Type 1 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06017089
• Other study ID #: 230262
• Secondary ID: U01DK127551-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 adverse events related to hypoglycemia and hyperglycemia, CGM-measured time spent below 54mg/dL, and CGM-measured time spent above 250 mg/dL. CGM-measured endpoints will be tested against baseline for non-inferiority.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 tested for superiority against baseline and a matched historical control population from the prior PEDAP study that did not involve the use of any AI-driven pump parameters. Up to 45 screened participants with the goal of at least 30 participants completing the study pump use period.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 1 month

2. Familiarity and use of a carbohydrate ratio for meal boluses

3. Age =2 and <6 years old

4. Using a Dexcom CGM at the time of enrollment, with use on at least 21 out of the prior 28 days

5. Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff

6. 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)

7. 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

8. Investigator has confidence that the parent 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 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

10. Total daily insulin dose (TDD) at least 5 Units/day

11. Body weight at least 20 pounds (lbs)

12. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial

13. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff

14. Parent/guardian proficient in reading and writing English

15. Live in the United States, with no plans to move outside the United States during the study period

Exclusion Criteria:

1. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)

2. Hemophilia or any other bleeding disorder

3. History of >1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months

4. History of >1 DKA event in the last 6 months not related to illness, infusion set failure, or initial diagnosis

5. History of chronic renal disease or currently on hemodialysis

6. History of adrenal insufficiency

7. Hypothyroidism that is not adequately treated in the opinion of the investigator

8. Use of oral or injectable steroids within the last 8 weeks

9. Known, ongoing adhesive intolerance

10. Plans to receive blood transfusions or erythropoietin injections during the course of the study

11. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk

12. Participation in another pharmaceutical or device trial at the time of enrollment or during the study

13. 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• AI-based Advisor system
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.

Locations

Country	Name	City	State
United States	Barbara Davis Center, University of Colorado	Aurora	Colorado
United States	University of Virginia	Charlottesville	Virginia
United States	Stanford University	Stanford	California

Sponsors (5)

Lead Sponsor	Collaborator
Marc Breton	Jaeb Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage below 54 mg/dL	Null Hypothesis: The difference in mean CGM-measured % below 54 mg/dL between the 8 weeks follow-up and baseline is greater than or equal to +0.5% (non-inferiority).	8 weeks
Primary	Percentage below 54 mg/dL	Alternative Hypothesis: The difference in mean CGM-measured % below 54 mg/dL between the 8 weeks follow-up and baseline is less than +0.5%.	8 weeks
Primary	Percentage above 250 mg/dL	Null Hypothesis: The difference in mean CGM-measured % above 250 mg/dL between the 8 weeks follow-up and baseline is greater than or equal to +3% (non-inferiority).	8 weeks
Primary	Percentage above 250 mg/dL	Alternative Hypothesis: The difference in mean CGM-measured % above 250 mg/dL between the 8 weeks follow-up and baseline is less than +3%.	8 weeks
Primary	Hierarchical Efficacy Endpoints (tested for superiority compared with baseline) CGM Measured	% Time in range 70-180 mg/dL	8 weeks
Primary	Hierarchical Efficacy Endpoints (tested for superiority compared with baseline) CGM Measured	Mean glucose	8 weeks
Primary	Hierarchical Efficacy Endpoints (tested for superiority compared with baseline) CGM Measured	% Time >250 mg/dL	8 weeks
Primary	Hierarchical Efficacy Endpoints (tested for superiority compared with baseline) CGM Measured	% Time <70 mg/dL	8 weeks
Primary	Hierarchical Efficacy Endpoints (tested for superiority compared with baseline) CGM Measured	% Time <54 mg/dL	8 weeks
Secondary	CGM Measured Time in Range	The percent of time spent within range, 70 mg/dL-140 mg/dL.	8 weeks
Secondary	CGM Measured	% Time >180 mg/dL	8 weeks
Secondary	CGM Measured	% Time >300 mg/dL	8 weeks
Secondary	CGM Measured	% Time <60 mg/dL	8 weeks
Secondary	CGM Measured	Glucose standard deviation	8 weeks
Secondary	CGM Measured	Glucose coefficient of variation	8 weeks
Secondary	CGM Measured	High blood glucose index (HBGI)	8 weeks
Secondary	CGM Measured	Low blood glucose index (LBGI)	8 weeks
Secondary	CGM Measured	Weekly hyperglycemic event rate	8 weeks
Secondary	CGM Measured	Weekly hypoglycemic event rate	8 weeks
Secondary	Binary outcome 1	% Time in range 70-180 mg/dL improvement from baseline to 8 weeks =5%	8 weeks
Secondary	Binary outcome 2	% Time in range 70-180 mg/dL improvement from baseline to 8 weeks =10%	8 weeks
Secondary	Binary outcome 3	% Time in range 70-180 mg/dL >70% and % time <70 mg/dL <4%	8 weeks
Secondary	Total daily insulin	Total daily insulin (units/kg)	8 weeks
Secondary	Basal Insulin	Percentage of total insulin delivered via basal administration.	8 weeks