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Artificial Pancreas

AI-Driven Insulin Pump for Type 1 Diabetes (PEDAP-AI Trial)

Q: Is the age of eligibility for this medical experiment greater than 20 years?

This medical trial has 2 to 5 year-olds as its target demographic; the minimum age for enrolment is two and the maximum age five.

Q: Has enrollment in this trial been opened to the public?

According to the information on ClinicalTrials.gov, this trial is not currently recruiting participants; it was initially posted in September 1st 2023 and last edited on August 23rd 2023. Nevertheless, there are 392 other clinical trials that are presently signing up patients for participation.

Q: How can I join the current research initiative?

This trial, which has spots for roughly 30 participants, is currently seeking individuals aged 2 to 5 who suffer from <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">type 1 diabetes</a>.

Q: What objective is this experiment attempting to achieve?

This 8-week trial primarily measures the safety endpoint of hyperglycemia. Secondary metrics include CGM Measured Mean Glucose (the average of values collected over the data collection period), CGM Measured Hypoglycemia (percentage of time spent below 70 mg/dL) and CGM Measured Glucose Coefficient of Variation (observed glucose variability expressed as standard deviation divided by mean multiplied by 100).

N/A

Recruiting

Led By Raj Paul Wadwa, MD

Research Sponsored by Marc Breton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥2 and <6 years old

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

PEDAP-AI Trial Summary

This trial evaluates the safety and effectiveness of an AI-driven pump for kids with Type 1 Diabetes, with participants using the system for 8 weeks.

Who is the study for?

This trial is for young children aged 2 to under 6 with Type 1 Diabetes, weighing at least 20 lbs, and using a Dexcom CGM. They must be able to attend training sessions, use the t:connect Mobile App daily, and have a guardian capable of emergency diabetes care. Exclusions include recent severe hypoglycemia or DKA events, steroid use within 8 weeks, other clinical trial participation, certain chronic conditions or treatments.Check my eligibility

What is being tested?

The study tests an AI-based Advisor system that adjusts parameters on an automated insulin pump (t:slim X2 with Control-IQ Technology) in kids with Type 1 Diabetes at home. Over eight weeks, it will assess safety and how well the AI-driven pump manages blood sugar levels when used alongside a Continuous Glucose Monitor.See study design

What are the potential side effects?

Potential side effects may include issues related to insulin delivery such as low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), skin irritation from device adhesives or sensors, and possible technical difficulties with the AI system or pump.

PEDAP-AI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 2 and 6 years old.

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I use at least 5 Units of insulin daily.

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I have been diagnosed with type 1 diabetes for at least 3 months.

PEDAP-AI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Safety Endpoint (Hyperglycemia)

Primary Safety Endpoint (Hypoglycemia)

Secondary outcome measures

Basal Insulin

Binary outcome 1

Binary outcome 2

+6 more

PEDAP-AI Trial Design

1Treatment groups

Experimental Treatment

Group I: AI Advisor-driven at-home closed loop system initiation and parameter adaptationExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Marc BretonLead Sponsor

4 Previous Clinical Trials

157 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,562 Total Patients Enrolled

Jaeb Center for Health ResearchOTHER

153 Previous Clinical Trials

34,881 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age of eligibility for this medical experiment greater than 20 years?

"This medical trial has 2 to 5 year-olds as its target demographic; the minimum age for enrolment is two and the maximum age five."

Answered by AI

Has enrollment in this trial been opened to the public?

"According to the information on ClinicalTrials.gov, this trial is not currently recruiting participants; it was initially posted in September 1st 2023 and last edited on August 23rd 2023. Nevertheless, there are 392 other clinical trials that are presently signing up patients for participation."

Answered by AI

How can I join the current research initiative?

"This trial, which has spots for roughly 30 participants, is currently seeking individuals aged 2 to 5 who suffer from type 1 diabetes."

Answered by AI

What objective is this experiment attempting to achieve?

"This 8-week trial primarily measures the safety endpoint of hyperglycemia. Secondary metrics include CGM Measured Mean Glucose (the average of values collected over the data collection period), CGM Measured Hypoglycemia (percentage of time spent below 70 mg/dL) and CGM Measured Glucose Coefficient of Variation (observed glucose variability expressed as standard deviation divided by mean multiplied by 100)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Pediatric Artificial Pancreas Automated Initialization Trial

Marc Breton 2023. "The Pediatric Artificial Pancreas Automated Initialization Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06017089.