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

June 23, 2016 updated by: Shireene Vethakkan, University of Malaya

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 control in women with insulin-requiring GDM with less hypoglycaemia
    2. Professional CGM use will alter management of insulin-requiring GDM
    3. Professional CGMS will reduce perinatal morbidity and mortality in patients with insulin- requiring GDM
    4. Third trimester CGMS parameters will correlate better with perinatal outcomes compared with conventional measures of glycaemic control in pregnancy i.e. fructosamine/ A1c/ FBS/ 2hrs PP glucose

STUDY DESIGN

  • This is a prospective, open-label, randomized controlled trial. We plan to recruit 80 women with gestational diabetes at 28 weeks gestation or less from the UMMC antenatal clinic. These women should be insulin-naïve but require insulin therapy. 40 subjects (Group 1) will be selected to undergo professional CGM at weeks 28, 32, and week 36 and another 40 subjects individually matched with regards, to age, baseline A1c, BMI will be recruited to undergo usual antenatal care without CGMS (Group 2). The CGMS data will be uploaded and reviewed at weeks 29, 33, and 37 and changes made to the therapeutic regimen as required by the endocrinologist. All mothers will be required to measure their glucose levels at 7 standardized points in a day daily. These glucose readings will be recorded in a diary together with a food log. All subjects will also be required to keep a hypoglycaemia diary.
  • The primary outcomes will be glycaemic control in the third trimester and maternal hypoglycaemia. We also plan to assess changes to management made by the endocrinologist based on the additional information on glycemic control obtained from professional CGM use. We also plan to compare hypoglycaemia and hyperglycaemia detection rates using the CGMS and fingerstick methods of glucose evaluation. Patient satisfaction in both groups will also be assessed. Written and informed consent will be obtained in accordance with the principles of the Helsinki Declaration

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Federal Territory
      • Kuala Lumpur, Federal Territory, Malaysia, 59100
        • University Malaya Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous 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.
Device: 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
Other Names:
  • iPro, Medtronic
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycemic Control by Measurement of HbA1c
Time Frame: From 28 weeks until delivery
From 28 weeks until delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Hypoglycemia
Time Frame: 28 weeks until delivery
28 weeks until delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Shireene R Vethakkan, MBBS,MD, University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

July 28, 2014

First Posted (Estimate)

July 30, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

June 23, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 961.7
  • PPUM/QSU/300-04/11 (Other Identifier: University Malaya Medical Centre, Malaysia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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