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

Gestational Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02204657
• Other study ID #: 961.7
• Secondary ID: PPUM/QSU/300-04/
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2014
• Last updated: July 28, 2014
• Start date: April 2013
• Est. completion date: August 2015

Study information

• Verified date: July 2014
• Source: University of Malaya
• Contact: Sharmila S Paramasivam, MD,MRCP
• Phone: +603-79494422
• Email: sharmsp13[@]gmail.com
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Federal Territory

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (10)

Balaji V, Balaji M, Anjalakshi C, Cynthia A, Arthi T, Seshiah V. Inadequacy of fasting plasma glucose to diagnose gestational diabetes mellitus in Asian Indian women. Diabetes Res Clin Pract. 2011 Oct;94(1):e21-3. doi: 10.1016/j.diabres.2011.07.008. Epub 2011 Aug 10. — View Citation

Chen R, Yogev Y, Ben-Haroush A, Jovanovic L, Hod M, Phillip M. Continuous glucose monitoring for the evaluation and improved control of gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2003 Oct;14(4):256-60. — View Citation

Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. Epub 2005 Jun 12. — View Citation

Klonoff DC, Buckingham B, Christiansen JS, Montori VM, Tamborlane WV, Vigersky RA, Wolpert H; Endocrine Society. Continuous glucose monitoring: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2011 Oct;96(10):2968-79. doi: 10.1210/jc.2010-2756. — View Citation

Klonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care. 2005 May;28(5):1231-9. Review. — View Citation

Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430. — View Citation

Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680. — View Citation

Sathyapalan T, Mellor D, Atkin SL. Obesity and gestational diabetes. Semin Fetal Neonatal Med. 2010 Apr;15(2):89-93. doi: 10.1016/j.siny.2009.09.002. Epub 2009 Oct 28. — View Citation

Tan PC, Ling LP, Omar SZ. The 50-g glucose challenge test and pregnancy outcome in a multiethnic Asian population at high risk for gestational diabetes. Int J Gynaecol Obstet. 2009 Apr;105(1):50-5. doi: 10.1016/j.ijgo.2008.11.038. Epub 2009 Jan 19. — View Citation

Yogev Y, Visser GH. Obesity, gestational diabetes and pregnancy outcome. Semin Fetal Neonatal Med. 2009 Apr;14(2):77-84. doi: 10.1016/j.siny.2008.09.002. Epub 2008 Oct 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control by measurement of HbA1c		From 28 weeks until delivery	No
Secondary	Number of patients with hypoglycemia and number of hypoglycemic events		28 weeks until delivery	No