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|
| General |
| Study Status |
Ongoing |
| 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
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| 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.
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| 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.
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
DKA participant event rate percentage: 3/144 = 2.08%. DKA event rate per 100 person years for all 4 events: 5.91. Severe hypoglycemia participant percentage: 1/144 = 0.69%. Severe hypoglycemia event rate per 100 person years for the 1 event: 1.48. 22 other reportable adverse events that occurred. Four of these events were device related. One was a skin infection at the site of the infusion set, and one was a skin infection at the sensor site. The two other device related events led to hypoglycemia, both related to use errors, that did not cause seizure or loss of consciousness.
Effectiveness Results:
Glycemic outcomes reported. Time in range (70-180 mg/dL): median 64.1% (IQR: 56.0-74.7%). Mean glucose: median 163.4 mg/dL (IQR: 146.7-180.1 mg/dL). Hyperglycemia: time >180 mg/dL median 33.0% (IQR: 22.7-41.8%), time >250 mg/dL median 11.4% (IQR: 5.1-17.8%). Time 70-140 mg/dL median 43.0% (IQR: 33.3-51.6%). Patient-reported outcomes including satisfaction, quality of life, and usability will be reported at study completion when all data are collected. CGM data available with median 181.0 days of data per participant. Technology distribution: 71.4% using Tandem Mobi pump, 28.6% using t:slim X2 pump. All participants using approved CGM sensors (88.2% Dexcom G7, 11.8% Dexcom G6). Four participants, who had less than 21 days of data, were excluded.
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| Actual Number of Patients Enrolled |
144 participants as of November 1, 2025
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| Actual Number of Sites Enrolled |
Not applicable. This is a decentralized, remote study design where all data collection occurs remotely with no live clinical visits conducted. Participants are recruited via automated electronic outreach from new users of the Control-IQ 1.5 System (CIQ+). Data is collected electronically via surveys and automated uploads of pump and CGM data, as well as via in- and out-bound telephone calls. No traditional clinical sites are utilized in this study design
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| Patient Followup Rate |
Not applicable at this interim timepoint. Participants have median 181.0 days of CGM data (IQR: 135.8-210.2 days). Survey completion rates: 1-month surveys 89.3% completion rate (117/131 completed), 2-month surveys 88.4% completion rate (130/147), 3-month surveys 90.3% completion rate (130/144), 4-month surveys 91.6% completion rate (109/119 completed), 5-month surveys 93.0% completion rate (93/100), 6-month surveys 91.3% completion rate (73/80), 7-month surveys 90.9% completion rate (30/33 completed), and 8-month surveys 100% completion rate (2/2). All enrolled participants will be monitored for 12 months after starting the Control-IQ System. Follow-up assessments include monthly surveys to collect adverse event incidence and surveys at 6 and 12 months to collect patient reported outcomes. Ongoing assessment of eligibility criteria including use of on-label insulin is rechecked every 3 months.
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