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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 weeks

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

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