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| General |
| Study Status |
Study Pending |
| 522 Number / Requirement Number |
PS240001 / PSS001 |
| Date Original Plan Accepted |
05/01/2024
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| Study Name |
iLet Postmarket Surveillance Study
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| Device Name |
Ilet dosing decision software
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| Root Document Number |
K220916
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
A one-year, prospective single-arm cohort study to collect safety and effectiveness data on the iLet Dosing
Decision Software during real-world use in people 6 years of age or older with type 1 diabetes (T1D).
The study will compare outcomes data during iLet use to efficacy and safety outcomes data derived from epidemiological studies, such as data published by the T1D
Exchange registry, and to the results of the Bionic Pancreas Pivotal Trial (BPPT), with a special emphasis on serious adverse effects such as severe hypoglycemia and DKA.
An analysis will be conducted comparing glycemic outcomes during iLet use to baseline pre-iLet CGM and HbA1c data in participants who have provided this data.
In addition, the study will determine the frequency and types of anticipated and unanticipated device issues experienced by users during real-world use.
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| Study Population |
Users must meet the following criteria in order to be enrolled in the study:
1. Diagnosed with type 1 diabetes and prescribed the iLet Bionic Pancreas System (with the iLet Dosing Decision Software installed)
2. At least 6 years of age
3. Using or planning to use either Novolog (insulin aspart) or Humalog (insulin lispro) in ready-to-fill cartridges, or Fiasp® PumpCart® (insulin aspart) in prefilled 1.6mL cartridges
4. Willing to provide HbA1c result obtained within the 12-month period prior to starting use of the iLet
5. Willing to provide CGM data, if available, obtained in the 1-month period prior to starting use of the iLet
6. For females, not pregnant or planning pregnancy in the next 12 months
7. Able to respond to alerts and alarms, and to provide basic diabetes self management
8. Reside full-time in the US
9. Able to speak and read English
10. Willing and able to download the iLet Mobile App and keep it active throughout
the study and upload device data regularly
11. Willing to answer baseline survey, monthly surveys, and share CGM data, and follow-up data, as necessary
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| Sample Size |
1,875 participants, with the goal of 1,500 completing the full 12-month surveillance period.
Approximately equal distribution between males and females, and approximately:
20% (377 people) ages 6-13 years old
20% (377 people) ages 14-17 years old
50% (938 people) ages greater than or equal to 18 years old
At least 40% pump naïve participants (greater than or equal to 750 people) defined as not having used an insulin pump during the preceding 6 months, and 50% of the cohort to be iLet naïve, defined as having started the iLet up to 1 month prior to enrollment.
At least 15% of the cohort with a minority race or ethnicity (Black non-Hispanic, Hispanic, Asian, American Indian/Alaskan native, or multi-racial).
At least 30% of the cohort with a baseline HbA1c greater than or equal to 8%
At least 20% of the cohort with a baseline HbA1c greater than or equal to 9%
No more than 30% of the cohort with a baseline HbA1c < 7%.
Number of sites: N/A. This will be a surveillance study centrally managed by Beta Bionics without specific study sites or site investigators
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| Key Study Endpoints |
Study Endpoints
Primary Endpoint: • Rate of severe hypoglycemia associated with cognitive impairment requiring the assistance of a third party for treatment
Key Secondary Endpoints:
• Rate of severe hypoglycemia associated with unconsciousness or seizure • Rate of diabetic ketoacidosis
Other Safety Endpoints:
• Rate of unanticipated adverse device effects
Other Endpoints:
CGM outcomes:
• Mean CGM glucose
• Percentage of time with CGM glucose < 54 mg/dL
• Percentage of time with CGM glucose < 70 mg/dL
• Percentage of time with CGM glucose 70–180 mg/dL
• Percentage of time with CGM glucose > 180 mg/dL
• Percentage of time with CGM glucose > 250 mg/dL
• Rate of hypoglycemic events, defined as at least 15 consecutive minutes of CGM glucose < 54 mg/dl
• Rate of hyperglycemic events, defined as at least 90 cumulative minutes with a CGM glucose value > 300 mg/dl within a 120-minute period
• Intrasubject coefficient of variation
Endpoints Related to BG-run Mode
• Percent of time spent in BG-run mode
• Percent of time spent in BG-run mode episodes longer than 4 hours
• Rate of severe hypoglycemic events beginning during BG-run mode episode lasting more than 4 hours
• Rate of DKA events during BG-run mode or within 6 hours of a BG-run episode lasting more than 4 hours
• Rate of unanticipated adverse device effects during BG-run mode
• Rate of participants entering BG-run mode episodes lasting more than 4 hours, both during the first 7 days of iLet use and after the first 7 days
• Average duration of BG-run mode episodes
• Average duration of BG-run mode episodes lasting more than 4 hours
• Percentage of time no insulin could be delivered during BG-run mode episodes lasting more than 4 hours as a result of failure to enter required BG values
• Percentage of BG-run mode episodes lasting more than 4 hours that end with no insulin being delivered because the user exceeded the maximum allowed durations of BG-run mode
• Average time interval between BG-values entered during BG-run mode episode lasting more than 4 hours
• Mean CGM glucose at the time of entry into BG-run mode for BG-run episodes lasting more than 4 hours
• Mean CGM glucose at the time of exit from BG-run mode for BG-run episodes lasting more than 4 hours
• Mean glucose of BG-values entered during BG-run mode for BG-run episodes lasting more than 4 hours
• Percent of BG values < 70 mg/dl during BG-run mode for BG-run episodes lasting more than 4 hours
Additional Outcomes
• Mean number of swipes to unlock the iLet per day
• Mean number of meal announcements made per day – total and by meal type
• Percentage of each size of meal announcement announced – total and by meal type
• Insulin total daily dose
• Ratio of total basal insulin to total daily insulin dose
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| Follow-up Visits and Length of Follow-up |
Surveys will be sent to each participant monthly inquiring about serious adverse events, including severe hypoglycemia and diabetic ketoacidosis, and device issues. Participants will also be queried about any changes to their diabetes management and iLet use.
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