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|
| General |
| Study Status |
Study Pending |
| 522 Number / Requirement Number |
PS230005 / PSS001 |
| Date Original Plan Accepted |
12/28/2023
|
| Date Current Plan Accepted |
05/03/2024
|
| Study Name |
Postmarket Surveillance Study
|
| Device Name |
Control-iq technology
|
| Root Document Number |
K232382
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Child: 2-12 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Primary objective: To demonstrate, in a real-world setting, the safety of the Control-IQ System for the management of type 1 diabetes by assessing the rate of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA).
Secondary objective: To demonstrate, in a real-world setting, the effectiveness of the Control-IQ System for the
management of type 1 diabetes by assessing the impact on patients’ glycemic outcomes and user experience in the real
world, during the first 12 months of use.
|
| Study Population |
Enrollment in the study will be available to all individuals age 2 to < 6 years of age at time of screening, who start therapy
with the Control-IQ 1.5 System once the Institutional Review Board (IRB) approval is received and the individual meets
the indications for use and the study eligibility criteria.
|
| Sample Size |
Number of subjects: 180
Assumptions for sample size estimation: 120
Number of sites: N/A
Site location: Remote (All data will be collected remotely, with no live clinical visits conducted. Data will be collected electronically, via surveys and automated uploads of pump and CGM data, as well as via in- and out-bound telephone calls)
|
| Key Study Endpoints |
Safety Endpoints
The incidence rates of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA)
Effectiveness Endpoints
1) To determine glycemic outcomes as a measure of efficacy of the Control-IQ System, and
2) To demonstrate patient-reported satisfaction with and trust in the Control-IQ System, usability of the system,
and improved quality of life.
|
| Follow-up Visits and Length of Follow-up |
100% of calls to Tandem Customer Technical Support will
be screened for reportable adverse events (AEs) based on the definitions of
SH and DKA included in this protocol. Outreach surveys will
be deployed to all study participants: Monthly to collect AE
incidence, and at 6 and 12 months to collect other patient reported outcomes (PROs).
Ongoing assessment of eligibility criteria to include using an
on-label insulin will be rechecked every 3 months.
All enrolled participants will be monitored from baseline through 12 months following the initiation of therapy with the
Control-IQ System.
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