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Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

NCT07011147

This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Type 1 Diabetes (T1D)
  • Type 2 Diabetes
  • Diabetes, Autoimmune
  • Diabetes Mellitus
  • Diabetes Mellitus Type 2
  • Diabetes Mellitus, Type I
  • Diabetes, Type II
  • Diabetes
  • Diabetes Mellitus, Insulin-Dependent
  • Diabetes Mellitus Type II
  • Diabetes Type 2 on Insulin

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
18 to 89 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
University of Colorado, Denver
Last updated on ClinicalTrials.gov
June 11, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Colorado · 1

  • University of Colorado Anschutz Medical Campus · Aurora, CO

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.