N/A
N=57
The Effect of Continuous Glucose Monitoring on Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus
Gestational Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02204657 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Glycemic Control by Measurement of HbA1c — 5.17; 5.57 mean percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Glucose Monitoring System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Malaya
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Control by Measurement of HbA1c |
5.17; 5.57 | — |
| SECONDARY Hypoglycemia |
8.0; 4.0 | — |
Summary
The purpose of this study is to determine if professional Continuous glucose monitoring improves glycemic control with less hypoglycaemia in insulin-requiring Gestational Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria
- women with gestational diabetes
- aged >18 years
- less than or equal to 28 weeks gestation of pregnancy
- singleton pregnancy
- insulin naive , but requiring insulin therapy
Exclusion Criteria
- pregestational type 1 or 2 diabetes mellitus
- newly diagnosed overt diabetes in pregnancy ( HbA1c > 6.5)
- hypothyroidism
- Cushing's syndrome/ using exogenous steroids
- chronic infection ( HIV, Hepatitis B/C, Tuberculosis)
- any active chronic systemic disease ( except essential hypertension)
- assisted conception
- pregnancies with fetal anomalies / where imminent or preterm delivery is likely because of maternal disease ( besides gestational diabetes)
Data sourced from ClinicalTrials.gov (NCT02204657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.