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Automated Insulin Delivery System

Tandem t:slim X2 with Control-IQ Technology Pro for Type 1 Diabetes

N/A
Waitlist Available
Research Sponsored by Marc Breton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hour period
Awards & highlights

Study Summary

This study is evaluating whether an automated insulin delivery system may help improve blood glucose control in young children with type 1 diabetes.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hour period
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hour period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time in Range
Secondary outcome measures
CGM-measured Mean Glucose
CGM-measured Percent Above 250 mg/dL
CGM-measured Percent Below 54 mg/dL
+2 more
Other outcome measures
Adverse Device Effects (ADE)
Any Adverse Event Rate
Body Mass Index (BMI)
+43 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CLC GroupExperimental Treatment2 Interventions
Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the intervention group will use the Tandem t:slim X2 with Control-IQ Technology v1.0 during the first 13 weeks of the study (RCT phase, weeks 1-13) and then use Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 for the remaining 13 weeks of the study (extension phase, weeks 14-26).
Group II: SC GroupActive Control2 Interventions
Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the SC group will use their existing insulin therapy in conjunction with study Dexcom G6 CGM during the first 13 weeks of the study (RCT phase, weeks 1-13). The SC group will then transition to using the Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 and study Dexcom G6 CGM for the remaining 13 weeks of the study (weeks 14-26).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tandem t:slim X2 with Control-IQ Technology Pro
2021
N/A
~110
Tandem t:slim X2 with Control-IQ Technology V1.5
2021
N/A
~110

Find a Location

Who is running the clinical trial?

Tandem Diabetes Care, Inc.Industry Sponsor
37 Previous Clinical Trials
5,585 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,139 Total Patients Enrolled
Jaeb Center for Health ResearchOTHER
152 Previous Clinical Trials
34,567 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes
Marc Breton 2021. "The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04796779.
~26 spots leftby Apr 2025
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