beta
Trial Radar AI
One study matched filter criteria
Card View
Back to Search

The Effect of Continuous Glucose Monitoring on Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus 50

Completed
Clinical Trial NCT02204657 was an interventional study for Gestational Diabetes Mellitus that is now completed. The study started on April 1, 2013, with plans to enroll 50 participants. Led by University of Malaya, the expected completion date was April 1, 2015. The latest data from ClinicalTrials.gov was last updated on August 5, 2016.
Brief 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
Detailed Description

  1. OBJECTIVES

    1. To determine if professional CGM improves glycemic control with less hypoglycaemia in insulin- requiring GDM
    2. To determine if professional CGM use alters management of insulin-requiring GDM
    3. To determine if professional CGM improves pregnancy outcomes in insulin-requiring GDM.
    4. To determine patient attitudes toward CGMS.

  2. HYPOTHESES

    1. Professional CGMS improves glycaemic con...
Show More
Official Title

The Effect of Professional Continuous Glucose Monitoring on Diabetes Management,Hypoglycemia and Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus

Conditions
Gestational Diabetes Mellitus
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 961.7
  • PPUM/QSU/300-04/11 (Other Identifier) (University Malaya Medical Centre, Malaysia)
NCT ID Number
NCT02204657
Start Date (Actual)
2013-04
Last Update Posted
2016-08-05
Completion Date (Estimated)
2015-04
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
Continuous glucose monitoring in GDM
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorContinuous Glucose Monitoring System
Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.
Continuous Glucose Monitoring System
Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings
No InterventionControl
Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Glycemic Control by Measurement of HbA1c
From 28 weeks until delivery
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Hypoglycemia
28 weeks until delivery
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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

  • 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)
University of Malaya logoUniversity of Malaya
Study Responsible Party
Shireene Vethakkan, Principal Investigator, Associate Professor and Consultant Endocrinologist, University of Malaya
No contact data.
1 Study Locations in 1 Countries

Kuala Lumpur

University Malaya Medical Centre, Kuala Lumpur, Kuala Lumpur, 59100, Malaysia