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Clinical Trial

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

NCT: NCT07011147 · RECRUITING

NCT IDNCT07011147
StatusRECRUITING
Start Date2026-01-16
Completion2029-04-01

Brief 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

Frequently Asked Questions

What is Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery?

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery is a clinical trial registered under NCT07011147. Current status: RECRUITING.

What is the status of NCT07011147?

The current status of NCT07011147 (Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery) is: RECRUITING.

When did Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery start?

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery started on 2026-01-16.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.