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
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Mellitus||Device: Continuous Glucose Monitoring System||Not Applicable|
- To determine if professional CGM improves glycemic control with less hypoglycaemia in insulin- requiring GDM
- To determine if professional CGM use alters management of insulin-requiring GDM
- To determine if professional CGM improves pregnancy outcomes in insulin-requiring GDM.
- To determine patient attitudes toward CGMS.
- Professional CGMS improves glycaemic control in women with insulin-requiring GDM with less hypoglycaemia
- Professional CGM use will alter management of insulin-requiring GDM
- Professional CGMS will reduce perinatal morbidity and mortality in patients with insulin- requiring GDM
- 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
- 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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Glycemic Control by Measurement of HbA1c [ Time Frame: From 28 weeks until delivery ]
- Hypoglycemia [ Time Frame: 28 weeks until delivery ]
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
|University Malaya Medical Centre|
|Kuala Lumpur, Federal Territory, Malaysia, 59100|
|Principal Investigator:||Shireene R Vethakkan, MBBS,MD||University of Malaya|