NCT07011147 (PREPARE 4 AID) is a NA clinical trial of Bionic Pancreas in Type 1 Diabetes (T1D), sponsored by University of Colorado, Denver.

Who is sponsoring NCT07011147?

NCT07011147 is sponsored by University of Colorado, Denver.

What drugs are being tested in NCT07011147?

Interventions in NCT07011147: Bionic Pancreas, Routine Care.

What condition does NCT07011147 study?

NCT07011147 studies 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.

Is NCT07011147 still recruiting?

NCT07011147 is currently recruiting now. Last updated 2 April 2026.

Last reviewed 2026-04-02 · How we verify

NCT07011147: PREPARE 4 AID

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

Recruiting now NA Last updated 2 April 2026

What this trial tests

NA trial testing Bionic Pancreas in Type 1 Diabetes (T1D) in 240 participants. Currently enrolling.

Timeline

16 January 2026

Primary endpoint
1 October 2026

1 April 2029

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	16 January 2026
Primary completion	1 October 2026
Estimated completion	1 April 2029
Sites	2 locations across United States

Drugs / interventions tested

Bionic Pancreas
Routine Care

Conditions studied

Type 1 Diabetes (T1D) — all drugs for Type 1 Diabetes (T1D) →
Type 2 Diabetes — all drugs for Type 2 Diabetes →
Diabetes, Autoimmune — all drugs for Diabetes, Autoimmune →
Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

University of Colorado, Denver

Who can join

Adults 18 to 89, any sex, with Type 1 Diabetes (T1D) or Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Bionic Pancreas

Trials testing the same drug.

NCT05168657 — Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth · NA · completed
NCT03258853 — Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes · NA · completed
NCT03262116 — Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancre · Phase 2, PHASE3 · terminated
NCT03552523 — The Set-Point Study for Type 2 Diabetes: Evaluating the Use of an Insulin Only Bionic Pancreas System in Type 2 Diabetes · NA · completed

Other recruiting trials for Type 1 Diabetes (T1D)

Currently open trials in the same condition.

NCT06782568 — Avoidance of Insulin-induced Lipohypertophy in People With Diabetes Using Ultrasound Scanning Within Diabetes Clinics · NA · recruiting
NCT07470593 — Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pan · recruiting
NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
NCT06883344 — Automated Insulin for Management of Intrapartum Glycemia · NA · recruiting
NCT06915831 — Type 1 Diabetes and Obstructive Sleep Apnea · NA · recruiting

Other University of Colorado, Denver trials

Trials by the same sponsor.

NCT07292285 — The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial. · not yet recruiting
NCT07021937 — Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity · Phase 3 · not yet recruiting
NCT07453732 — Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients. · NA · not yet recruiting
NCT07038278 — 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma · EARLY_PHASE1 · not yet recruiting
NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07011147 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
Last refreshed: 2 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07011147.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing