Status:
COMPLETED
A Clinical Study to Investigate and Compare the Impact of High Protein Pasta, Lower Protein Pasta and White Rice on Blood Sugar Control in People With Type 1 Diabetes Mellitus (T1DM)
Lead Sponsor:
Sansum Diabetes Research Institute
Collaborating Sponsors:
Harvard University
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this clinical study is to investigate and compare the postprandial glycemic response to three different meal types rich in carbohydrates, that is, white pasta, high protein pasta and white ...
Detailed Description
The aim of this clinical study is to investigate and compare the postprandial glycemic response to three different meal types rich in carbohydrates, that is, white pasta, high protein pasta and white ...
Eligibility Criteria
Inclusion
- Age ≥ 18 and ≤ 75 years at the time of screening.
- Clinical diagnosis of type 1 diabetes for at least one year.
- HbA1c ≤ 10%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
- Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes, and boluses for all meals and snacks that contain ≥ 5 grams of carbohydrate.
- Willing to refrain from taking acetaminophen products for the duration of the clinical trial. If acetaminophen is taken, subject is to avoid making any insulin dosing decisions based on CGM for at least 12 hours.
- For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile at the screening visit. Subjects who become pregnant will be discontinued from the study.
- Willing to abide by the study protocol and use study-provided devices.
Exclusion
- Gastrointestinal disease such as celiac disease or multiple food allergies.
- Any form of gluten sensitivity or wheat allergy.
- Allergies to any form of nuts and ingredients present in the study meals (tomatoes etc).
- History of gastroparesis.
- Pregnancy.
- Dermatological conditions that would preclude wearing a CGM sensor.
- Screening A1c \> 10%.
- Any condition that could interfere with participating in the trial, based on the investigator's judgment.
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03362151
Start Date
January 1 2018
End Date
August 2 2018
Last Update
September 5 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105