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Pancreatic Enzyme Replacement
Pancreatic Enzyme Replacement Therapy for Type 1 Diabetes (CREON Trial)
Phase < 1
Waitlist Available
Led By Daniel Moore, MD, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Total daily dose of insulin greater than 0.7u/kg/day
Reduction of pancreas volume (<0.6mL/kg body weight)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (4-5 weeks)
Awards & highlights
CREON Trial Summary
This trial tests whether pancreatic enzyme replacement therapy can improve glycemic responsiveness, reduce hypoglycemia, and improve symptoms of pancreatic exocrine insufficiency in people with T1DM who have reduced pancreatic volume.
Who is the study for?
This trial is for adults over 18 with Type 1 Diabetes, who've had it for at least a year, use a continuous glucose monitor and smartphone, and get care from the Eskind Diabetes Clinic. They should have reduced pancreas size and not be pregnant or breastfeeding, on restrictive diets, using other diabetes meds besides insulin, or have celiac or bowel disease.Check my eligibility
What is being tested?
The study tests if CREON (pancreatic enzyme replacement) can help manage blood sugar in Type 1 Diabetes by improving glycemic response and reducing hypoglycemia compared to a placebo. Participants will provide data from their glucose monitors to see how well CREON works.See study design
What are the potential side effects?
While specific side effects are not listed here, pancreatic enzyme replacements like CREON may cause digestive issues such as stomach pain, gas, bloating; allergic reactions; and changes in blood sugars.
CREON Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I use more than 0.7 units of insulin per kilogram of my body weight daily.
Select...
My pancreas is smaller than usual for my body weight.
Select...
I am over 18 years old.
CREON Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (4-5 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (4-5 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in glucose regulation
Patient-reported change in pancreatic exocrine insufficiency (PEI) symptoms
CREON Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: CREONActive Control1 Intervention
CREON is a pancreatic enzyme replacement
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatment for Type 1 Diabetes (T1D) is insulin therapy, which replaces the insulin that the pancreas is unable to produce, thereby regulating blood glucose levels and preventing complications. Additionally, Pancreatic Enzyme Replacement Therapy (PERT), such as CREON, is being studied for its potential to improve glycemic control and reduce symptoms of pancreatic exocrine insufficiency by supplementing digestive enzymes.
This is particularly important for T1D patients with reduced pancreatic volume and exocrine function, as it can enhance nutrient absorption and stabilize blood glucose levels.
Progress in the development of immune-based therapies for type 1 diabetes mellitus.[Conservative treatment of chronic pancreatitis].Interactions between the endocrine and exocrine pancreas and their clinical relevance.
Progress in the development of immune-based therapies for type 1 diabetes mellitus.[Conservative treatment of chronic pancreatitis].Interactions between the endocrine and exocrine pancreas and their clinical relevance.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
865 Previous Clinical Trials
673,143 Total Patients Enrolled
Daniel Moore, MD, PhDPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of celiac disease or inflammatory bowel disease.I use medication or supplements, not including insulin, to manage my blood sugar.You are following a strict diet, like a very low carb diet.I use more than 0.7 units of insulin per kilogram of my body weight daily.My pancreas is smaller than usual for my body weight.I have been diagnosed with Type 1 Diabetes for over a year.You are currently using a continuous glucose monitor.I am over 18 years old.You currently use a smartphone.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: CREON
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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