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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 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.

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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

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

FieldValue
Enrollment Target 240 participants
Start Date 2026-02-01
Est. Completion 2029-04-01
Phase NA

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT07011147

The ClinicalTrials.gov registry entry for NCT07011147 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (95% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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