|
General |
Study Status |
Ongoing |
522 Number / Requirement Number |
PS200008 / PSS001 |
Date Original Plan Accepted |
04/30/2020
|
Date Current Plan Accepted |
03/24/2022
|
Study Name |
Postmarket Surveillance
|
Device Name |
Control-iq technology
|
Root Document Number |
K200467
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
Historical Control
|
Analysis Type |
Descriptive
|
Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
This postmarket surveillance study is a single-arm, prospective study. It is designed to assess 12-month safety in a real-world setting, and to support the continued assessment of the Control-IQ System for the treatment of type 1 diabetes in the United States. In addition, data will be collected to assess glycemic outcomes and user experience.
|
Study Population |
Children: 6-13 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults): 18-21 yrs, Adult: >21
|
Sample Size |
Overall sample size remains unchanged. Enrollment targets changed from 193 to 163 for the 6-9 years old cohort, and from 58 to 18, for the 6-13 years old cohort who are CGM naïve.
|
Key Study Endpoints |
Safety Endpoints: 1. The composite rates of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA), and 2. The safety of the automatic population of CGM readings the bolus calculator of the Control-IQ System Secondary Endpoints: 3. To determine glycemic outcomes as a measure of efficacy of the Control-IQ System, and 4. To demonstrate patient-reported satisfaction with and trust in the Control-IQ System, usability of the system, and sleep quality.
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Follow-up Visits and Length of Follow-up |
Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment”. Participants will be considered screen failures if Control-IQ data has not been downloaded to t:connect 120 days after the baseline survey's completion.
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Interim or Final Data Summary |
Interim Results |
There is a reduction in the reported rate of severe hypoglycemia events from 13.15 to 11.63 per 100 patient-years but an increase in diabetes ketoacidosis events from 1.02 to 1.42 per 100 patient-years for the current reporting period. There is no evidence that the auto-population of CGM values into the bolus calculator results in the calculation of insulin boluses that are less safe than boluses delivered not using the auto-population feature. There were no Unanticipated Adverse Device Effects.
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Actual Number of Patients Enrolled |
2726
|
Actual Number of Sites Enrolled |
1
|
Patient Followup Rate |
Total number of subjects reaching each designated study phase: o 1-month survey: 1,868 o 2-month survey: 2114 o 3-month survey: 2185 o 4-month survey: 2240 o 5-month survey: 2216 o 6-month survey: 2161 o 7-month survey: 2103 o 8-month survey: 2,118 o 9-month survey: 2,103 o 10-month survey: 2,022 o 11-month survey: 1712 o 12-month survey: 1715
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Study Strengths and Weaknesses |
Strengths: Tandem has met their overall enrollment goals. Weaknesses: The study population enrolled to date is predominantly White.
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