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Monitoring of Postprandial Glycemic Variability in Healthy Young Infants (IGVM)

Primary Purpose

Infant Conditions, Glucose Intolerance

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Glucose monitoring

About this trial

This is an interventional diagnostic trial for Infant Conditions focused on measuring Glucose variation, Infant, Nutrition, interstitial glucose variation

Eligibility Criteria

6 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Term infants (boys and girls)
6 to 12 months old
In good general health
Nourished with diverse nutrition including infant formula, solid foods such as mixed meat and vegetable preparation or marketed preparations
Infant child: if the child is breastfed partially, it can be included in the study. In this case, only samples of a food supplement will be collected for evaluation of the composition.
Hospitalized at the Lausanne Children's Hospital for non-severe reasons that do not affect or suspect to affect glucose metabolism
Measures of feeding (time and compositions with samples) feasible for 3 consecutive days by the parents at home

Exclusion Criteria:

Child born premature
One or both parents with type 2 diabetes or gestational diabetes
Child totally breastfed
Chronic skin condition such as eczema, excessive dryness.
Allergy known to adhesive plaster
Infectious diseases affecting the skin (eg chickenpox, scarlet fever,)
disorders of cutaneous microcirculation
Infants suffering from diseases affecting nutrition or digestion (diarrheal gastroenteritis) and children undergoing antibiotic treatment that may affect gastrointestinal absorption
Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or Diathermy Therapy

Sites / Locations

Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Glucose monitoring

Arm Description

FreeStyle® Libre Pro Interstitial Glucose Meter will be applied after skin preparation with anesthetic cream (Emla® ) and glucose measurements will be monitored during 2-5 days. Oral food intake will be recorded.

Outcomes

Primary Outcome Measures

Prandial glucose variations

Change of preprandial to postprandial glucose measurements, expressed in mmol/l

Secondary Outcome Measures

Full Information

NCT ID

NCT03819725

First Posted

December 23, 2018

Last Updated

June 21, 2021

Sponsor

University of Lausanne Hospitals

Collaborators

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT03819725

Brief Title

Monitoring of Postprandial Glycemic Variability in Healthy Young Infants

Acronym

IGVM

Official Title

Monitoring of Postprandial Glycemic Variability in Healthy Young Infants

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

January 14, 2019 (Actual)

Primary Completion Date

April 30, 2021 (Actual)

Study Completion Date

April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Lausanne Hospitals

Collaborators

Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant Conditions, Glucose Intolerance

Keywords

Glucose variation, Infant, Nutrition, interstitial glucose variation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glucose monitoring

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Glucose monitoring

Intervention Description

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.

Primary Outcome Measure Information:

Title

Prandial glucose variations

Description

Change of preprandial to postprandial glucose measurements, expressed in mmol/l

Time Frame

up to 5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Term infants (boys and girls) 6 to 12 months old In good general health Nourished with diverse nutrition including infant formula, solid foods such as mixed meat and vegetable preparation or marketed preparations Infant child: if the child is breastfed partially, it can be included in the study. In this case, only samples of a food supplement will be collected for evaluation of the composition. Hospitalized at the Lausanne Children's Hospital for non-severe reasons that do not affect or suspect to affect glucose metabolism Measures of feeding (time and compositions with samples) feasible for 3 consecutive days by the parents at home Exclusion Criteria: Child born premature One or both parents with type 2 diabetes or gestational diabetes Child totally breastfed Chronic skin condition such as eczema, excessive dryness. Allergy known to adhesive plaster Infectious diseases affecting the skin (eg chickenpox, scarlet fever,) disorders of cutaneous microcirculation Infants suffering from diseases affecting nutrition or digestion (diarrheal gastroenteritis) and children undergoing antibiotic treatment that may affect gastrointestinal absorption Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or Diathermy Therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Hauschild, MF

Organizational Affiliation

CHUV

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1011

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Monitoring of Postprandial Glycemic Variability in Healthy Young Infants

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