The Effect of Real-time Continuous Glucose Monitoring on Severe Complications to Pregnancy in Women With Diabetes

NCT00994357 | Completed

• 1 other identifier: SENSOR-01
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to investigate the effects of Real-time Continuous Glucose Monitoring on severe complications to pregnancy in women with diabetes.

Conditions

Diabetes; Pregnancy

Keywords

Real-time Continuous Glucose Monitoring; Macrosomia

Outcome Measures

Primary Outcomes (1)

• Prevalence of LGA in children of diabetic women.

  Obtained shortly after birth

Secondary Outcomes (4)

• Metabolic control in terms of HbA1c, blood sugar measurements and the occurence of severe hypoglycemia in pregnant diabetic patients.

  During pregnancy

• Quality of life, locus of control and anxiety and depression scores in pregnant diabetic patients.

  During pregnancy

• Neonatal disease such as neonatal hypoglycemia, respiratory distress and the occurrence of malformations in children of diabetic mothers.

  Shortly after birth

• The occurrence of low grade inflammation and endothelial dysfunction in pregnant women with diabetes.

  During pregnancy

Study Arms (2)

Real-time Continuous Glucose Monitoring

EXPERIMENTAL

Real-time Continuous Glucose Monitoring at five times for up to 6 days during pregnancy, and during delivery, in addition to standard monitoring and treatment.

Device: Real-time CGM

Control group

ACTIVE COMPARATOR

Standard monitoring and treatment of diabetic patients during pregnancy.

Other: Standard care

Interventions

Real-time CGM DEVICE

See previous description.

Real-time Continuous Glucose Monitoring

Standard care OTHER

See text.

Control group

Eligibility Criteria

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

You may qualify if:

• Pregestational diabetes, type 1 or type 2
• Single intrauterine pregnancy
• At least 18 years old
• Informed consent

You may not qualify if:

• Mental disorders
• Language barriere
• Gemelli
• Diabetic nephropathy

Sponsors & Collaborators

• University of Copenhagen: lead

Related Publications (2)

• Cordua S, Secher AL, Ringholm L, Damm P, Mathiesen ER. Real-time continuous glucose monitoring during labour and delivery in women with Type 1 diabetes - observations from a randomized controlled trial. Diabet Med. 2013 Nov;30(11):1374-81. doi: 10.1111/dme.12246. Epub 2013 Jul 26.

  PMID: 23758126 DERIVED

• Secher AL, Ringholm L, Andersen HU, Damm P, Mathiesen ER. The effect of real-time continuous glucose monitoring in pregnant women with diabetes: a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1877-83. doi: 10.2337/dc12-2360. Epub 2013 Jan 24.

  PMID: 23349548 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elisabeth R Mathiesen, M.D.

  Center for Pregnant Women with Diabetes, Copenhagen University Hospital

  STUDY CHAIR

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: MD

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: May 1, 2012
• Last Updated: May 9, 2012

Record last verified: 2012-05