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
Sponsored by
About this trial
This is an interventional diagnostic trial for Infant Conditions focused on measuring Glucose variation, Infant, Nutrition, interstitial glucose variation
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
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
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
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Monitoring of Postprandial Glycemic Variability in Healthy Young Infants
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