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Device

Automated Insulin Delivery Settings Initialization and Adaptation Algorithm for Type 1 Diabetes

N/A
Waitlist Available
Research Sponsored by Tandem Diabetes Care, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a smart system that helps set up and adjust insulin delivery automatically. It targets people who are switching from multiple daily insulin injections. The system aims to improve blood sugar control faster by automatically adjusting settings based on the user's needs. Automated insulin delivery (AID) systems have been developed to improve glucose control by automatically adjusting insulin delivery based on continuous glucose monitoring.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diabetic Ketoacidosis Events
Severe Hypoglycemic Events
Secondary study objectives
Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion
Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion
Median Sensor Glucose
+22 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular UpdatesExperimental Treatment1 Intervention
After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Automated Insulin Delivery Settings Initialization and Adaptation Algorithm
2022
N/A
~40

Find a Location

Who is running the clinical trial?

Tandem Diabetes Care, Inc.Lead Sponsor
39 Previous Clinical Trials
5,640 Total Patients Enrolled
Jordan E Pinsker, MDStudy ChairTandem Diabetes Care, Inc.
9 Previous Clinical Trials
178 Total Patients Enrolled
~9 spots leftby Nov 2025
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