← Back to Search

Artificial Pancreas System

Bionic Pancreas for Cystic Fibrosis

N/A

Waitlist Available

Led By Steven J Russell, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 3-14

Awards & highlights

Study Summary

This trial is testing a new system that automatically gives insulin and glucagon to people with cystic fibrosis related diabetes. The goal is to see if it can better regulate blood sugar than the current standard of care.

Eligible Conditions

Diabetes-Related Cystic Fibrosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 3-14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 3-14

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 3-14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14

Secondary outcome measures

Coefficient of Variation

Mean CGM Glucose

Number of Episodes of Self-reported Symptomatic Hypoglycemia

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Insulin only bionic pancreasExperimental Treatment1 Intervention

Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.

Group II: Usual CareActive Control1 Intervention

Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bionic Pancreas

2017

N/A

~190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,333 Total Patients Enrolled

8 Trials studying Cystic Fibrosis

1,405 Patients Enrolled for Cystic Fibrosis

Beta Bionics, Inc.Industry Sponsor

5 Previous Clinical Trials

519 Total Patients Enrolled

Steven J Russell, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

16 Previous Clinical Trials

319 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for individuals to join this trial?

"According to the information readily available on clinicaltrials.gov, this research is looking for suitable participants. This trial was first registered on August 26th 2021 and its details were most recently amended on November 8th 2022."

Answered by AI

What is the current recruitment capacity for this trial?

"Affirmative, clinicaltrials.gov points to this trial as actively recruiting patients. The study was posted on August 26th 2021 and has recently been revised on November 8th 2022. To date, the research team is looking for 60 individuals from 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes

Melissa Susan Putman 2021. "Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03258853.