NCT03819725

Monitoring of Postprandial Glycemic Variability in Healthy Young Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Lausanne Hospitals · Academic / Other
• Sex: All
• Age: 6 Months – 12 Months
• Healthy volunteers: Accepted

Summary

To measure and quantify the postprandial glucose variations in response to a meal in the healthy 6-12 months old child and correlate this response with the composition of this meal.

Detailed description

14 full-term infants (boys and girls) aged six to twelve months and fed a diversified diet including infant formula, solid foods such as mixed meat and vegetable preparation or marketed preparations will be recruited. Children will be recruited in the Lausanne Childrens hospital and only be included in the study whenin good general health. FreeStyle® Libre Pro Interstitial Glucose Meter will be applied on the last day before discharge from the hospital after skin preparation with anesthetic cream (Emla®) during hospitalization and measurements will be recorded during 2-5 days. It is not intended to measure capillary or venous blood glucose levels during this study. However, if blood is collected during hospitalization, blood glucose will be measured in parallel with the interstitial glucose measured with the device. The child will follow his usual diet without modifications. The amount of food consumed by the child as well as the length of the meals will be recorded by the parents. For meals made by the parents they will be asked to keep a sample not seen to analyze their carbohydrate content. The total carbohydrate content will be measured .

Conditions

• Infant Conditions
• Glucose Intolerance

Interventions

Type	Name	Description
DEVICE	Glucose monitoring	FreeStyle® Libre Pro Interstitial Glucose Meter will be applied after skin preparation with anesthetic cream (Emla®) . Interstitial glucose measurements will be recorded during 2-5 days and during meals.

Timeline

• Start date: 2019-01-14
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2019-01-28
• Last updated: 2021-06-22

Locations

1 site across 1 country: Switzerland