Diabetes-Specific Formula on Long Term Glycemic Control
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus - Type 2
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Determine the effects of a diabetes-specific formula [1-2 servings per day as a (partial) meal replacement] in addition to standard of care on HbA1c level, in comparison with the standard of care onlyMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 21 years and 65 years
- Gender
- Both males and females
Description
This is a randomized, controlled, parallel study. Eligible participants will be randomly allocated (at 1 :1 ratio) to one of two groups: DSF group or control group.The total expected duration of the study is 97 days. There are two periods in the study: i) "Run-in Period" (Study Days -6 to -1): parti...
This is a randomized, controlled, parallel study. Eligible participants will be randomly allocated (at 1 :1 ratio) to one of two groups: DSF group or control group.The total expected duration of the study is 97 days. There are two periods in the study: i) "Run-in Period" (Study Days -6 to -1): participants will wear the CGMS:Continuous Glucose Monitoring System (FreeStyle Libre Pro) and will be asked to follow and track their diet and physical activity on a daily basis. ii) "Intervention Period" (Study Days 0 to 90): participants will be randomized into one of the two groups (n = 125 per group): DSF group or control group.
Tracking Information
- NCT #
- NCT04345497
- Collaborators
- Not Provided
- Investigators
- Study Chair: Agnes Siew Ling Tey, Ph.D. Abbott Nutrition
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