Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by Jaeb Center for Health Research.
NCT04016662 is a Phase 4 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 82 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Primary Outcome: Percentage of sensor glucose values \<70 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. Since the hypoglycemia endpoints had skewed distributions, values were winsorized at the 10th and 90th percentiles.
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 |
What the finished NCT04016662 record still lists
NCT04016662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04016662's enrollment target sits among peer trials
82 939th of 2000 higher than 1,061 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03319901 · 82 participants · Phase 1
Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL
- NCT03493425 · 82 participants · Phase 2
Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery
- NCT04105270 · 82 participants · Phase 2
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
- NCT04428658 · 82 participants · NA
Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI