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Trial record 3 of 5 for:    15951574 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02204657
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Shireene Vethakkan, University of Malaya

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

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Device: Continuous Glucose Monitoring System Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Professional Continuous Glucose Monitoring on Diabetes Management,Hypoglycemia and Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus
Study Start Date : April 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

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 Name: 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.



Primary Outcome Measures :
  1. Glycemic Control by Measurement of HbA1c [ Time Frame: From 28 weeks until delivery ]

Secondary Outcome Measures :
  1. Hypoglycemia [ Time Frame: 28 weeks until delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204657


Locations
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Malaysia
University Malaya Medical Centre
Kuala Lumpur, Federal Territory, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Shireene R Vethakkan, MBBS,MD University of Malaya

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shireene Vethakkan, Associate Professor and Consultant Endocrinologist, University of Malaya
ClinicalTrials.gov Identifier: NCT02204657     History of Changes
Other Study ID Numbers: 961.7
PPUM/QSU/300-04/11 ( Other Identifier: University Malaya Medical Centre, Malaysia )
First Posted: July 30, 2014    Key Record Dates
Results First Posted: August 5, 2016
Last Update Posted: August 5, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shireene Vethakkan, University of Malaya:
Continuous glucose monitoring in GDM
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs