Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07011147 · ClinicalTrials.gov registry record · NA
Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery
A NA study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 2
- Study locations
NCT07011147: Recruiting NA study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by University of Colorado, Denver.
NCT07011147 is a NA study of Diabetes Mellitus, Type 2 and Diabetes that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 240 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07011147, a NA study of Diabetes Mellitus, Type 2 and Diabetes, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is: Can the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)? Researchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care. Participants will: Use the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks
Primary Outcome
Superiority testing for HbA1c at 13 weeks between the BP and RC groups using linear mixed effects regression models adjusting for baseline HbA1c.
Conditions Studied
Interventions
- OTHER Routine Care
- DEVICE Bionic Pancreas
Study Locations (2)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2026-02-01 |
| Est. Completion | 2029-04-01 |
| Phase | NA |
What NCT07011147 shows while recruiting
NCT07011147 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (95% lower).
The record links to 10 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Routine Care is the first listed.
NCT07011147 reports a single indexed study location in Colorado, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07011147 about?
NCT07011147 is a clinical study titled "Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery". The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to an...
What is the current status of trial NCT07011147?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2026-02-01. Estimated completion is 2029-04-01.
What conditions does trial NCT07011147 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes, Type 2 Diabetes, Diabetes Mellitus, Type 1 Diabetes (T1D).
What interventions are being tested in trial NCT07011147?
The interventions under investigation include: Routine Care (OTHER), Bionic Pancreas (DEVICE).
Who is sponsoring clinical trial NCT07011147?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07011147 being conducted?
This trial has 2 study locations across Colorado, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07011147's enrollment target sits among peer trials
240 141st of 348 higher than 208 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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
-
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
RECRUITING · NA
-
Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance
RECRUITING · NA
-
Trial to Assess Continuous Glucose Monitoring in Asian Americans With Type 2 Diabetes
RECRUITING · NA
-
Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic Population
RECRUITING · NA
-
Phenotyping Genetic Risk for Type 2 Diabetes
RECRUITING · NA
-
Diabetes Learning in Virtual Environments Just in Time for Community Reentry
RECRUITING · NA
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
- NCT02855554 · 240 participants · NA
Quantitative Cardiac Parametric Mapping
- NCT03230565 · 240 participants · Phase 4
Continuous Infusions vs Scheduled Bolus Infusions
- NCT03399929 · 240 participants
Traumatic Brain Injury and Stroke Long Term Outcome
- NCT03583710 · 240 participants · Phase 3
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
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