Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes (CREON)

Vanderbilt University Medical Center

Status and phase: Completed; Early Phase 1

Conditions: Type 1 Diabetes

Treatments: Drug: CREON; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05266963

210734

Details and patient eligibility

About

Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas.

To date there has not been an investigation of the potential for pancreatic enzyme replacement therapy in the management of T1D. In individuals with cystic fibrosis-related diabetes, enzyme replacement has been shown to reduce post-prandial glycemia excursions, which are reflected in improved GLP-1 responses to mixed meal tolerance testing. As post-prandial excursions and glucose variability are a significant challenge in T1D, how enzyme replacement may impact these parameters is an important question.

The investigators hypothesize that patients with T1DM who have reduced pancreatic volume will have improved glycemic responsiveness, reduced hypoglycemia, and improved symptoms of pancreatic exocrine insufficiency when treated with pancreatic enzyme replacement (CREON).

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently receive care at the Eskind Diabetes Clinic at Vanderbilt University Medical Center
• Diagnosed with T1DM for at least 12 months
• Age over 18
• Total daily dose of insulin greater than 0.7u/kg/day
• Current use of a continuous glucose monitor
• Current use of smart phone
• Able to read and speak English
• Willingness and ability to download and provide CGM and pump (if applicable) data
• Reduction of pancreas volume (<0.6mL/kg body weight)

Exclusion criteria

• History of celiac disease or inflammatory bowel disease
• Use of medication or supplements other than insulin to control blood glucose
• Pregnancy or breast feeding
• Following a restrictive diet (such as very low carb diet)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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11 participants in 2 patient groups, including a placebo group

CREON

Active Comparator group

Description:

CREON is a pancreatic enzyme replacement

Treatment:

Drug: CREON

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo