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Monitoring of Postprandial Glycemic Variability in Healthy Young Infants

Monitoring of Postprandial Glycemic Variability in Healthy Young Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03819725
Acronym
IGVM
Enrollment
10
Registered
2019-01-28
Start date
2019-01-14
Completion date
2021-04-30
Last updated
2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Intolerance, Infant Conditions

Keywords

Glucose variation, Infant, Nutrition, interstitial glucose variation

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 .

Interventions

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.

Sponsors

Société des Produits Nestlé (SPN)
CollaboratorINDUSTRY
University of Lausanne Hospitals
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prandial glucose variationsup to 5 daysChange of preprandial to postprandial glucose measurements, expressed in mmol/l

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026