NCT01102452CompletedNot Applicable
A Randomized, Two-Regimen, Crossover, Comparative Study to Evaluate the Blood Glucose Regulation and Safety of PPB-R-203-02 Based Noodle Versus Commercially Available Wet Noodle in 24 Patients With Diabetes
Pharma Power Biotec Co., Ltd.1 site in 1 country24 target enrollmentStarted: April 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- The daily blood glucose level will be monitored by the CGMS (continuous glucose monitoring system)device
Study Overview
Brief Summary
To evaluate the result of PPB-R-203-02 based noodle and commercially available wet noodle on blood glucose control in 24 patients with diabetes for 2 days.
Detailed Description
The MiniMed Medtronic CGMS (continuous glucose monitoring system), the first model approved by FDA, was used for subcutaneous glucose monitoring. The CGMS continually measures the glucose concentration of the interstitial fluid every 10 seconds and then stores an average glucose value for each 5 minutes period, for a total of up to 288 measurements each day.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diabetes mellitus patient.
- •Aged between 20 to 65 years old.
- •Informed consent form signed.
Exclusion Criteria
- •A recent history of drug or alcohol abuse.
- •Sensitivity to analogous product.
- •Serious cardiovascular disorders.
- •Participation in another clinical investigation study.
- •Ongoing influenza, autoimmune disease and other metabolic diseases.
- •Pregnant or lactating women.
- •Individuals are judged by the investigators or co-investigator to be undesirable as subjects.
Outcomes
Primary Outcomes
The daily blood glucose level will be monitored by the CGMS (continuous glucose monitoring system)device
Time Frame: 2 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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