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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
Adult subjects ≥ age 18 years
Clinical diagnosis of type 1 diabetes for at least one year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 weeks
Awards & highlights
Study Summary
This trial will test a new algorithm for use with a medical device intended to help manage diabetes.
Eligible Conditions
- Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Severe Hypoglycemic Events
Secondary outcome measures
4-Hour post meal glucose AUC
Adverse Device Effects
CGM Metrics by time of day
+12 moreTrial 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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Who is running the clinical trial?
Tandem Diabetes Care, Inc.Lead Sponsor
37 Previous Clinical Trials
5,654 Total Patients Enrolled
Jordan E Pinsker, MDStudy ChairTandem Diabetes Care, Inc.
9 Previous Clinical Trials
183 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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