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Pancreatic Enzyme Replacement

Pancreatic Enzyme Replacement Therapy for Type 1 Diabetes (CREON Trial)

Q: Are there any new candidates who can join the trial at this moment?

<p>Per the information available on clinicaltrials.gov, this medical examination is currently not recruiting subjects. Originally posted on September 2nd 2022 and last updated on September 27th 2022, no applicants are being sought for enrolment at present. Nonetheless, there are an abundance of other trials that do require participants; 1262 to be exact.</p>

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 below

Select...

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (4-5 weeks) for reporting.

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,182 Total Patients Enrolled

Daniel Moore, MD, PhDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

CREON (Pancreatic Enzyme Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT05266963 — Phase < 1

Type 1 Diabetes Research Study Groups: Placebo, CREON

Type 1 Diabetes Clinical Trial 2023: CREON Highlights & Side Effects. Trial Name: NCT05266963 — Phase < 1

CREON (Pancreatic Enzyme Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05266963 — Phase < 1

Frequently Asked Questions

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

Are there any new candidates who can join the trial at this moment?

"Per the information available on clinicaltrials.gov, this medical examination is currently not recruiting subjects. Originally posted on September 2nd 2022 and last updated on September 27th 2022, no applicants are being sought for enrolment at present. Nonetheless, there are an abundance of other trials that do require participants; 1262 to be exact."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

Daniel Moore 2022. "Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05266963.