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NCT04809285 · ClinicalTrials.gov registry record · NA
Use of the Guardian™ Connect System With Smart Connected Devices
A NA study, sponsored by Medtronic MiniMed.
- Completed
- Registry status
- NA
- Development phase
- 217
- Enrollment target
NCT04809285: Completed NA study, sponsored by Medtronic MiniMed.
NCT04809285 is a NA study that has completed, run by Medtronic MiniMed. The registered enrollment target is 217 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04809285, a NA study, has completed, sponsored by Medtronic MiniMed.
- COMPLETED
- Registry status
- NA
- Development phase
- 217 participants
- Enrollment target
Study Summary
The purpose of this study is to collect sensor, insulin, sleep, activity and food/meal data for a minimum of 90 days of device wear (Phase 1) and up to a maximum of 9 months of device wear (Phase 2) with optional insulin injection video capture and/or menstrual cycle tracking and/or cardiac monitoring in subjects with insulin requiring diabetes 2-80 years of age.
Primary Outcome
The overall mean percentage of time in hypoglycemia (SG \< 70 mg/dL)
Interventions
- DEVICE Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2021-04-06 |
| Est. Completion | 2023-09-29 |
| Phase | NA |
What the finished NCT04809285 record still lists
NCT04809285 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app is the first listed.
NCT04809285 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04809285 about?
NCT04809285 is a clinical study titled "Use of the Guardian™ Connect System With Smart Connected Devices". The purpose of this study is to collect sensor, insulin, sleep, activity and food/meal data for a minimum of 90 days of device wear (Phase 1) and up to a maximum of 9 months of device wear (Phase 2) with optional insulin injection video capture and/or menstrual cycle tracking and/or cardiac monitori...
What is the current status of trial NCT04809285?
This trial is currently completed. It is a NA study. The enrollment target is 217 participants. The study started on 2021-04-06. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT04809285?
The interventions under investigation include: Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app (DEVICE).
Who is sponsoring clinical trial NCT04809285?
This trial is sponsored by Medtronic MiniMed, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04809285's enrollment target sits among peer trials
217 485th of 2000 higher than 1,516 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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