NCT04345497

Diabetes-Specific Formula on Long Term Glycemic Control

A Randomized Controlled Trial to Determine the Effects of a Diabetes-specific Formula on Long-term Glycemic Control and Short-term Glycemic Variability in Individuals With Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Abbott Nutrition · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study aims to investigate the effect of a diabetes-specific formula (DSF) used as a (partial) meal replacement on long-term glycemic control and short-term glycemic variability in individuals with type 2 diabetes.

Detailed 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): 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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
OTHER	Diabetes-Specific Formula	Diabetes-Specific Formula and Standard of Care
OTHER	Standard Of Care	Standard of Care

Timeline

• Start date: 2020-08-26
• Primary completion: 2022-12-06
• Completion: 2022-12-06
• First posted: 2020-04-14
• Last updated: 2023-02-14

Locations

5 sites across 2 countries: Malaysia, Thailand