Study Summary
This study is intended to test a Web-based Information Tool (WIT) software providing additional information regarding time in range, GMI, hypo- and hyperglycemia risks, variability tracker, daily glycemic profiles, and potential changes of insulin pump parameters, to users of a commercially available Closed-Loop Control (CLC) System (Control-IQ Technology).
Eligible Conditions
- Type 1 Diabetes
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 4 weeks
4 weeks
CGM-measured coefficient of variation during the day
Glucose
CGM-measured percent above 180 mg/dL during the day
CGM-measured percent below 70 mg/dL during the day
CGM-measured percent time in range 70-180 mg/dL
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
CLC, then CLC+BAM, then CLC+ABC
1 of 2
CLC+ABC, then CLC+BAM, then CLC
1 of 2
Active Control
90 Total Participants · 2 Treatment Groups
Primary Treatment: CLC, then CLC+BAM, then CLC+ABC · No Placebo Group · N/A
CLC, then CLC+BAM, then CLC+ABCActiveComparator Group · 2 Interventions: CLC + BAM, CLC + ABC · Intervention Types: Device, Device
CLC+ABC, then CLC+BAM, then CLCActiveComparator Group · 2 Interventions: CLC + BAM, CLC + ABC · Intervention Types: Device, Device
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks
Who is running the clinical trial?
Sue BrownLead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,148 Previous Clinical Trials
4,074,659 Total Patients Enrolled
Tandem Diabetes Care, Inc.Industry Sponsor
34 Previous Clinical Trials
4,040 Total Patients Enrolled
Sue Brown, MDPrincipal InvestigatorUniversity of Virginia Center for Diabetes Technology
14 Previous Clinical Trials
926 Total Patients Enrolled
Eligibility Criteria
Age 18 - 70 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be at least 18 years old at the time of consent.
You are using or willing to use insulin parameters such as carbohydrate ratio and correction factors consistently on your pump in order to dose insulin for meals or corrections.
You have access to the internet and you are willing to upload data during the study as needed.
Unbiased ResultsWe believe in providing patients with all the options.
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Conditions
Cancer Related
Treatments