|
|
| General |
| Study Status |
Delayed |
| 522 Number / Requirement Number |
PS220002 / PSS001 |
| Date Original Plan Accepted |
02/10/2023
|
| Study Name |
SmartAdjust Technology
|
| Device Name |
Insulet smartadjust
|
| Root Document Number |
K203774
K220394
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Decentralized observational clinical registry
|
| Study Population |
Individuals, 2 years of age and older, with Type 1 diabetes (T1D).
|
| Sample Size |
A minimum of 2,200 Type 1 participants will be recruited to ensure a
minimum of 1,650 participants completing at least 12 months of follow-up.
The minimum number of completed participants are as follows:
• 150 participants aged 2-5
• 300 participants aged 6-13
• 300 participants aged 14-17
• 900 participants aged 18+
In addition, enrollment targets for Type 1 diabetes specific populations of
interest, include a minimum of 1100 Omnipod-naïve users, 880 pump naïve
users, and 110 CGM-naïve users.
Assumptions for sample size estimation: The sponsor did not provide assumptions for sample size estimation.
Number of sites: N/A
Sites location: N/A
|
| Key Study Endpoints |
Safety Endpoints
Primary:
• Incidence rate of severe hypoglycemia (events per person months)
• Incidence rate of diabetic ketoacidosis (DKA) (events per person months)
Effectiveness Endpoints
Primary: Effectiveness will be evaluated using the following per participant
endpoints as compared to baseline when available:
• A1C (at 3, 6, 9 and 12 months)
• Glycemic outcomes
o Percentage of time < 54 mg/dL
o Percentage of time < 70 mg/dL
o Percentage of time > 180 mg/dL
o Percentage of time > 250 mg/dL
o Percentage of time in range 70-180 mg/dL
o Mean glucose
o Standard deviation of glucose
o Glucose management indicator
o Percentage of participants achieving A1C <7%
o Percentage of participants with time in range >70%
o Percentage of participants with time below range (<70mg/dL) of < 4%
Insulin usage (units, units/kg)
• BMI or BMI z-score (at 6 and 12 months)
• Participant-reported outcome questionnaires at baseline, 6 months and
end of registry participation (or withdrawal from registry)
• EQ-5D (inclusive of the Visual Analogue Scale (VAS))
• Insulin Delivery Systems: Perceptions, Ideas, Reflections, and
Expectations (INSPIRE)
• System Usability Scale (SUS)
• Incidence rate of prolonged hyperglycemia (events per person
months) during usage of Activity Mode
• Incidence rate of prolonged hyperglycemia (events per person
months)
• Incidence rate of prolonged hyperglycemia (events per person
months) during usage of a Target Glucose of 140 mg/dL or 150
mg/dL
• Glucose outcomes during the 4-hour post-bolus period using the
SmartBolus Calculator:
o Percentage of time < 54 mg/Dl
o Percentage of time in range 70-180 mg
|
| Follow-up Visits and Length of Follow-up |
Participants are expected to be followed for 12 months. Insulet stated that they will continue to collect safety data through their postmarket reporting after participants have completed the study.
|
