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

University of Copenhagen

Status: Completed

Conditions: Diabetes; Pregnancy

Treatments: Device: Real-time CGM; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT00994357

SENSOR-01

Details and patient eligibility

About

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.

Full description

Pregnancy outcome in women with type 1 or type 2 diabetes is still significantly poorer than in the background population. The prevalence of large fat babies (LGA) is 50% in both types of diabetes, and perinatal death and preterm delivery is 4-7 times higher than in non-diabetic women. These complications are all closely related to non-optimal glycemic control in pregnancy, and improved metabolic control is crucial in our strive for improved pregnancy outcome in these patients.

In 2007, a new generation of "real-time" Continuous Glucose Monitoring (CGM) became available in Denmark. These sensors estimate tissue glucose values automatically and frequently with immediate display of the glucose level. In addition it is possible to set alarms for high and low glucose levels, and the patient can react immediately with changes in diet or insulin dose.

In this trial, 154 patients were randomized to either continuous glucose monitoring at five times in pregnancy in addition to standard care ot to unchanged standard care. The main aim is to evaluate if the use of CGM in pregnancy can reduce the prevalence of LGA from 50 to 30%, but other outcome measurements such as preterm delivery, neonatal disease, hypoglycemia, low grade inflammation and vascular dysfunction, quality of life and self- care are also recorded.

Enrollment: 154 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Past gestational week 14 at inclusion
• Mental disorders
• Language barriere
• Gemelli
• Diabetic nephropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Real-time Continuous Glucose Monitoring

Experimental group

Description:

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.

Treatment:

Device: Real-time CGM

Control group

Active Comparator group

Description:

Standard monitoring and treatment of diabetic patients during pregnancy.

Treatment:

Other: Standard care