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

NCT02204657 | Completed Results DMC

• 2 other identifiers: 961.7PPUM/QSU/300-04/11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Gestational Diabetes Mellitus

Keywords

Continuous glucose monitoring in GDM

Outcome Measures

Primary Outcomes (1)

• Glycemic Control by Measurement of HbA1c

  From 28 weeks until delivery

Secondary Outcomes (1)

• Hypoglycemia

  28 weeks until delivery

Study Arms (2)

Continuous Glucose Monitoring System

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

Continuous Glucose Monitoring System DEVICE

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

Also known as: iPro, Medtronic

Continuous Glucose Monitoring System

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (11)

• 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.

  PMID: 18818254 BACKGROUND

• 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. doi: 10.1080/jmf.14.4.256.260.

  PMID: 14738172 BACKGROUND

• 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.

  PMID: 18926784 BACKGROUND

• 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. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.

  PMID: 15951574 BACKGROUND

• 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.

  PMID: 19154997 BACKGROUND

• 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.

  PMID: 21831468 BACKGROUND

• 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.

  PMID: 21976745 BACKGROUND

• Klonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care. 2005 May;28(5):1231-9. doi: 10.2337/diacare.28.5.1231. No abstract available.

  PMID: 15855600 BACKGROUND

• 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.

  PMID: 19797280 BACKGROUND

• 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.

  PMID: 19875346 BACKGROUND

• Paramasivam SS, Chinna K, Singh AKK, Ratnasingam J, Ibrahim L, Lim LL, Tan ATB, Chan SP, Tan PC, Omar SZ, Bilous RW, Vethakkan SR. Continuous glucose monitoring results in lower HbA1c in Malaysian women with insulin-treated gestational diabetes: a randomized controlled trial. Diabet Med. 2018 Aug;35(8):1118-1129. doi: 10.1111/dme.13649. Epub 2018 May 23.

  PMID: 29663517 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Limitations and Caveats

small sample size

Results Point of Contact

• Title: Dr Sharmila SP
• Organization: University Malaya Medical Centre

sharmsp13@gmail.com

60379492299

Study Officials

• Shireene R Vethakkan, MBBS,MD

  University of Malaya

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Consultant Endocrinologist

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 5, 2016
• Results First Posted: August 5, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)