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Follow up Glucose Levels Among Infants of Diabetic Mothers

This study has been completed.
Information provided by:
Sheba Medical Center Identifier:
First received: June 13, 2006
Last updated: June 28, 2009
Last verified: June 2009

Infants to diabetic mothers (IDM) are at risk for developing hypoglycemia after birth. Glucose level follow ups are recommended to each IDM. However, there are no recommendations as to how long this follow up should be performed for, nor are there "safe" glucose levels that allow stopping glucose monitoring.

The aim of the study is to retrospectively follow up glucose levels among IDMs in order to find risk factors for developing hypoglycemia and determine time and glucose levels that would permit monitoring cessation.

Condition Phase
Newborn Full Term Diabetic Mother Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 250
Study Start Date: June 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

A retrospective study of 250-300 IDMs, born in a single large medical center. Data will be collected as follows: Gestational age, birth weight, sex, delivery mode, type of maternal diabetes, other maternal diseases, feeding mode. Glucose levels as were recorded according to newborn protocol (1,2,4,6 hours after delivery, and then every 8 hours for total of 48 hours). Data of hypoglycemia treatment, if given, will be collected.

Later we will statistically try to determine the risk factors for developing hypoglycemia and the "safe" time and glucose levels to stop monitoring.


Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic

Inclusion Criteria:

  • Full-term infants, diabetic mothers, Singleton

Exclusion Criteria:

  • Preterm infants, multiple pregnancy, congenital malformations, clinically ill at birth.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00337142

Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Ayala Maayan, MD Sheba Medical Center
  More Information

Responsible Party: Dr. Ayala Maayan, Sheba Medical Center Identifier: NCT00337142     History of Changes
Other Study ID Numbers: SHEBA-06-4266-AM-CTIL
Study First Received: June 13, 2006
Last Updated: June 28, 2009

Keywords provided by Sheba Medical Center:
gestational diabetes
hypoglycemia processed this record on September 25, 2017