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Other Enrolling
A study to evaluate the insulin-only Bionic Pancreas in people with cystic fibrosis 14 years of age or older who have cystic fibrosis-related diabetes (CFRD) (Bionic Pancreas CFRD IOBP V 1.0. )
This study will evaluate the effectiveness and safety of using the insulin-only Bionic Pancreas (BP) system compared to using one’s usual insulin delivery method.
The first part of this study is a randomized controlled trial, meaning participants will not get to choose if they are selected for the insulin-only BP system or if they are selected to continue to use their usual insulin delivery method. During the second part of the study all participants will use the insulin-only BP system for an additional 13--week extension phase. Researchers will be monitoring participants’ glucose levels using a continuous glucose monitor over the entire 26 weeks of the study.
The study requires continues glucose monitoring and may also require blood draws, and questionnaires.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
14 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Potential participants must have a clinical diagnosis of CFRD treated with insulin for at least 3 months prior to screening.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
7 months -
Number of Study Visits:
4
Additional Information
-
Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Putman, Melissa -
Study Drugs:
N/A
Study Sites
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Enrolling Soon
Colorado
Children's Hospital Colorado, Aurora, CO 80045
Contact
Mary Cross
Phone: +1 (720) 777-4645
Email: mary.cross@childrenscolorado.org
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Enrolling Soon
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30322
Contact
Ashleigh Streby
Phone: +1 (404) 727-0305
Email: ashleigh.streby@emory.edu
-
Enrolling
Massachusetts
Massachusetts General Hospital, Boston, MA 02114
Contact
Margot Hardcastle
Phone: +1 (617) 726-3719
Email: mhardcastle@mgh.harvard.edu
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Enrolling Soon
Minnesota
Children’s Hospitals and Clinics of Minnesota, Minneapolis, MN 55404
Contact
Elizabeth Franck Thompson
Phone: +1 (612) 813-6347
Email: elizabeth.franckthompson@childrensmn.org
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Enrolling Soon
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
Contact
Participant Contact University of Minnesota
Phone: +1
Email: cftrials@umn.edu
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Enrolling Soon
Missouri
Children's Mercy Kansas City, Kansas City, MO 64108
Contact
Candy Schmoll
Phone: +1 (816) 302-3538
Email: cschmoll@cmh.edu
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Enrolling Soon
Nebraska
University of Nebraska Medical Center, Omaha, NE 68198
Contact
Michel Veit
Phone: +1 (402) 559-7585
Email: michel.veit@unmc.edu
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Enrolling Soon
New York
Children's Hospital of New York, New York, NY 10032
Contact
Hossein Sadeghi
Phone: +1 (212) 305-5122
Email: HS762@cumc.Columbia.edu
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Enrolling Soon
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
Contact
Primary RC & Participant Contact General Contact
Phone: +1
Email: RainbowCFResearch@UHhospitals.org
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Enrolling Soon
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, PA 19104
Contact
Erin Donnelly
Phone: +1 (609) 781-0307
Email: Donnellye4@email.chop.edu
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Enrolling Soon
Texas
University of Texas Health Sciences Center - San Antonio, San Antonio, TX 78229
Contact
Betsy Tanner
Phone: +1 (210) 743-8601
Email: tannerb@uthscsa.edu
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Enrolling
Virginia
University of Virginia, Charlottesville, VA 22903
Contact
Erica Tharrington
Phone: +1 (434) 297-7773
Email: SFV6AB@hscmail.mcc.virginia.edu
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
14 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Potential participants must have a clinical diagnosis of CFRD treated with insulin for at least 3 months prior to screening.
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