Status:
COMPLETED
Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 panc...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05266963
Start Date
September 2 2022
End Date
March 22 2024
Last Update
March 28 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232