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NCT04016662 · ClinicalTrials.gov registry record · Phase 4
Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)
A Phase 4 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 82
- Enrollment target
NCT04016662 is a Phase 4 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 82 participants.
The verdict
NCT04016662, a Phase 4 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
Study Summary
A multi-center, randomized, crossover trial consisting of three sequential 12-week periods, with the HCL feature used during one period, the PLGS feature used during one period and SAP therapy (control) during one period. The crossover trial will be preceded by a run-in phase in which participants will receive training using the study devices (Dexcom G6 and Tandem t:slim X2 pump). After the last crossover period, participants will be given the opportunity to use study devices for an additional 12 weeks to assess preference of system use (PLGS, HCL or SAP) and associated characteristics, durability and safety in a more real-world setting with less frequent study contact.
Interventions
- DEVICE Tandem t:slim X2 with HCL or PLGS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2020-09-28 |
| Est. Completion | 2024-01-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04016662
The ClinicalTrials.gov registry entry for NCT04016662 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tandem t:slim X2 with HCL or PLGS is the first listed.
NCT04016662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04016662 about?
NCT04016662 is a clinical study titled "Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)". A multi-center, randomized, crossover trial consisting of three sequential 12-week periods, with the HCL feature used during one period, the PLGS feature used during one period and SAP therapy (control) during one period. The crossover trial will be preceded by a run-in phase in which participants w...
What is the current status of trial NCT04016662?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2020-09-28. Estimated completion is 2024-01-05.
What interventions are being tested in trial NCT04016662?
The interventions under investigation include: Tandem t:slim X2 with HCL or PLGS (DEVICE).
Who is sponsoring clinical trial NCT04016662?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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