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| General |
| Study Status |
Ongoing |
| 522 Number / Requirement Number |
PS250004 / PSS001 |
| Date Original Plan Accepted |
06/25/2025
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| Date Current Plan Accepted |
06/25/2025
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| Study Name |
DEKA Loop Postmarket Surveillance Study
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| Device Name |
Deka loop
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| Root Document Number |
K234055
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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 |
Prospective, observational, cohort/active surveillance postmarket study
The objectives of the study are:
- To assess the safety and effectiveness of the DEKA Loop or twiist AID system in the expected intended use population
- This will include individuals of different racial/ethnic groups, over a wide age range from 6 years old to older adults, with a range of hemoglobin A1c (HbA1c)
levels
- Safety events will include severe hypoglycemia and diabetic ketoacidosis (DKA)
- To assess the safety and effectiveness profile of the twiist AID system across a range of user-programmable
features, including the following:
- the higher and lower ends of the user-programmable glucose correction range of 87 to 180 mg/dL
- lower minimum glucose safety limit
- adult and pediatric insulin models
- correction ranges used during exercise
- meal size and action time (lollipop, taco, pizza) as a measure of active carbohydrates
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| Study Population |
Inclusion Criteria:
1. Willing and able to provide informed consent (or a parent or other legally authorized representative)
2. Age greater than or equal to 6 years old
3. Diagnosis of T1D
4. Currently using twiist AID system, with initiation of twiist within 90 days of enrollment
- A minimum of 80% of the cohort will need to have initiated twiist within 30 days of enrollment
5. Willing to only use an insulin approved for the pump
6. Residing in United States
7. Willing to use twiist in accordance with the user manual
8. Willing to have the study use the twiist data and any information that has been provided to Sequel Medtech,
LLC or customer support since twiist was started
9. Willing to complete surveys at the beginning of the study and then monthly for 12 months.
10. Willing to be contacted if clarification or further information is needed for any events reported on a
survey or to customer support
11. Willing to obtain medical records or sign a record release for any hospitalizations
12. Has cell service or if not, will have access to WIFI at least once a week (needed for the pump data to be
uploaded to the cloud)
13. For females, not pregnant or planning pregnancy in the next 12 months
14. Able to speak and read English
15. Able to obtain documentation of HbA1c result obtained within 6 months prior to twiist initiation
Exclusion Criteria:
1. Any form of diabetes other than T1D
2. Receiving dialysis for end-stage renal disease
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| Sample Size |
Number of subjects: 1875 enrolled to achieve a minimum target of 1500 completing 12 months of follow up period. The
following are minimum enrollment targets per subpopulation:
- 15% 6 to <14 years old
- 15% 14 to <18 years old
- 15% greater than or equal to 50 years old
- 35% 18 to <50 years old
- 15% with a minority race or ethnicity
- 15% with annual family income <$75,000
- 25% with HbA1c (self-reported) prior to starting twiist greater than or equal to 7.5%
- 20% who had not used an insulin pump in the 6 months prior to starting twiist
Assumptions for sample size estimation: 20% of participants will discontinue the study prior to 12 months
Number of sites: N/A
Sites 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)
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| Key Study Endpoints |
Safety Endpoints
Primary: Severe hypoglycemia events (cognitive impairment sufficient to require the assistance of a third party for
treatment)
The following are key secondary endpoints:
- Severe hypoglycemia events associated with seizure or loss of consciousness
- Diabetic ketoacidosis
- Hospitalizations related to use of twiist
- Unanticipated adverse device effects
Effectiveness Endpoints
CGM-measured
The following endpoints will be calculated from CGM data:
- Glucose management indicator (GMI, estimate of HbA1c)
- 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 70-140 mg/dL
- Percentage of time with CGM glucose > 180 mg/dL
- Percentage of time with CGM glucose > 250 mg/dL
- Mean glucose
- Coefficient of variation
- Percentage of participants with time-in-range 70-180 mg/dL >70.0% HbA1c (verified by having participant upload screen shot or
photo of lab report/EHR note):
The following will be calculated from self-reported HbA1c levels:
- Change in HbA1c
- Percentage of participants with HbA1c <7.0%
Insulin
The following insulin delivery metrics will be calculated:
- Total daily insulin
- Total daily bolus insulin
- Total daily basal insulin
Endpoints Related to twiist
The following endpoints related to the twiist pump:
- Percentage of time in closed-loop mode
- Percentage of time CGM data available
- Frequency of occlusion alarms
- Frequency of target range usually used for exercise (participant self-report)
- Frequency of use of pump settings
o Each correction range
o Each glucose safety limit setting
o Adult and pediatric insulin models
o Each meal size
o Each action time (lollipop, taco, pizza)
o Pre-meal range
o Workout range
o Maximum basal
o Maximum bolus
o Insulin sensitivity
o One-button bolus
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| Follow-up Visits and Length of Follow-up |
Participants will be contacted by email or text to complete an online survey monthly for 12 months.
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