|
|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS190006 / PSS001 |
| Date Original Plan Accepted |
04/30/2020
|
| Date Current Plan Accepted |
03/24/2022
|
| Study Name |
Postmarket Surveillance Study
|
| Device Name |
Control-iq, algorithm
|
| Root Document Number |
DEN190034
|
| 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 |
Assessment
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.
|
| 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.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
3007
|
| Actual Number of Sites Enrolled |
Tandem is enrolling all subjects and collecting all data as a central Site. No other clinical study site is involved in this surveillance study.
|
| Patient Followup Rate |
N=2,849 Have completed the study (and counting toward Enrollment Goals)
|
| Final Safety Findings |
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 have been no Unanticipated Adverse Device Effects (UADE’s).
|
| Final Effectiveness Findings |
The rates of severe hypoglycemia and diabetic ketoacidosis while using the Control-IQ system in the real world are lower than those reported in populations using standard care.
Time in range analysis shows median time in range 70-180 mg/dL was 70.1% for adults, and above 60% for both children and adolescents, meeting international consensus guidelines for time in range across all age groups. Time in hypoglycemia was very low across the study.
|
| Study Strengths and Weaknesses |
Adverse event rates are significantly below those reported from standard of care therapy prior to Control-IQ technology use.
|
| Recommendations for Labeling Changes |
no labeling change
|
