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Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy (CONCEPTT)

This study is currently recruiting participants.
Verified May 2013 by Sansum Diabetes Research Institute
Sponsor:
Information provided by (Responsible Party):
Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier:
NCT01734031
First received: November 21, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

The primary objective of the study is to determine if Real-Time Continuous Glucose Monitor (CGM) devices can improve glycemic control in women with type 1 diabetes (T1D) who are pregnant or planning pregnancy without substantially increasing the rate of hypoglycemia.

Women with type 1 diabetes are at high risk for complications in pregnancy: high birth weight, congenital malformation, stillbirth, and neonatal death. These complications are associated with poor blood sugar control. CGM devices have been shown to help non-pregnant women improve their blood sugar control, but there is not enough evidence yet to be sure if or how pregnant women benefit from CGM device use. The purpose of the study is to evaluate whether real-time CGM devices will assist women with type 1 diabetes to improve their glycemic control before and during pregnancy.


Condition Intervention
Type 1 Diabetes
 Device: Continuous Glucose Monitor
Device: home glucose meter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Sansum Diabetes Research Institute:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 34 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • glucose variability [ Time Frame: 34 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: May 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pre-pregnant
Use of continuous glucose monitor versus traditional home glucose meter alone in the insulin management in women planning a pregnancy for optimal glycemic control.
 Device: Continuous Glucose Monitor
CGM devices use a glucose sensor that is inserted under the skin. The glucose sensor can be placed under the skin anywhere on the body but usually on the abdomen, flank or arms. The sensor measures the glucose in the interstitial fluid under the skin every 5 minutes and sends the values to a receiver. The glucose values can be read on the receiver. CGM wearers still need to check their blood sugar with a home glucose meter. The sensor will work for 6 days and then needs to be replaced. This is done by the CGM wearer at home.
Other Name: CGM
Device: home glucose meter
The standard treatment of women with type 1 diabetes who are planning pregnancy or are pregnant is the use of insulin and diet and monitoring of blood glucose values by home blood glucose meters before and after each meal.
Other Name: HGM
Active Comparator: Pregnant
Use of continuous glucose monitor versus traditional home glucose meter alone in the insulin management in pregnant women for optimal glycemic control.
 Device: Continuous Glucose Monitor
CGM devices use a glucose sensor that is inserted under the skin. The glucose sensor can be placed under the skin anywhere on the body but usually on the abdomen, flank or arms. The sensor measures the glucose in the interstitial fluid under the skin every 5 minutes and sends the values to a receiver. The glucose values can be read on the receiver. CGM wearers still need to check their blood sugar with a home glucose meter. The sensor will work for 6 days and then needs to be replaced. This is done by the CGM wearer at home.
Other Name: CGM
Device: home glucose meter
The standard treatment of women with type 1 diabetes who are planning pregnancy or are pregnant is the use of insulin and diet and monitoring of blood glucose values by home blood glucose meters before and after each meal.
Other Name: HGM

Detailed Description:

Before conception it is very important to get blood sugars very well controlled. This is because high blood sugars at the time of conception and in the very early weeks of pregnancy can be associated with a higher than average risk of malformations in the baby. If however, blood sugars are very close to normal, then the chance of a person with type 1 diabetes having a baby with malformations is the same as that in the general population.

During pregnancy it is very important to get blood sugars very well controlled. This is because high blood sugar levels can cause a baby to grow bigger than the average baby. This can make delivery of the baby difficult, leading to potential injury for the baby as well as for the mother. In addition, the baby may have problems after birth which include breathing difficulties and low blood sugar which may require the baby to be admitted to the intensive care unit. When pregnant, diabetics can have difficulty controlling blood sugar.

The standard treatment of women with type 1 diabetes before pregnancy and in pregnancy is the use of insulin and diet and monitoring of blood glucose values by home blood glucose meters before and after each meal.

This trial is trying to evaluate the benefit of using a real-time continuous glucose monitor (CGM) during pregnancy to help get blood sugars into target. The CGM system that will be used in the study at Sansum is the Dexcom SEVEN PLUS CGM, which has been approved in the United States. The Dexcom SEVEN Plus is made by Dexcom and has its own handheld receiver for displaying and storing data from the sensor.

These CGM devices use a glucose sensor that is inserted under the skin. The glucose sensor can be placed under the skin anywhere on the body but usually on the abdomen, flank or arms. The sensor measures the glucose in the interstitial fluid under the skin every 5 minutes and sends the values to a receiver. The wearer can see the glucose values on the receiver. The wearer still needs to check blood sugar with a home glucose meter. The Dexcom sensor will work for 6 days and then needs to be replaced. This is done by the wearer, at home. We believe that using this CGM sensor may help improve blood sugar control in women planning pregnancy and in pregnant women compared to standard monitoring; however, it is not yet clear whether or not it will.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • DM1 more than one year
  • Age 18-40 years
  • Uses an insulin pump or more than 3 shots per day
  • Planning pregnancy or pregnant
  • Wishes to optimize glycemic control before or during conception
  • If pregnant: Live singleton fetus gestational age less than 12 weeks and 6days at enrollment
  • Subject doesn't plan to move
  • Informed Consent

Exclusion Criteria:

  • Type 2 diabetes
  • Gestational diabetes onset
  • Estimated GFR <60 ml/min/1.73
  • Previous participation in the study
  • Regular home user of Continuous Glucose Monitor in the previous 3 months
  • Inpatient psychiatric treatment in the past 6 months
  • Premixed fixed dose of insulin use at the time of enrollment
  • Medical disorder/medication that would affect the Continuous Glucose Monitor or protocol
  • Pre-pregnant with HbA1c less than 7.0% or more than 10.0%
  • Pregnant with HbA1c less than 6.5% or more than 10.0%
  • Higher order pregnancy
  • Known potentially major fetal anomaly (EUROCAT criteria)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734031

Contacts
Contact: Lois Jovanovic, M.D. 805-682-7638 ljovanovic@sansum.org

Locations
United States, California
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Contact: Alison Wollitzer, Ph.D.     805-682-7640 ext 252     awollitzer@sansum.org    
Principal Investigator: Lois Jovanovic, M.D.            
Sub-Investigator: Kristin Castorino, D.O.            
Sponsors and Collaborators
Sansum Diabetes Research Institute
Investigators
Principal Investigator: Lois Jovanovic, M.D. Sansum Diabetes Research Institute
  More Information

Additional Information:
Sansum Diabetes Research Institute  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT01734031     History of Changes
Other Study ID Numbers: 12-66
Study First Received: November 21, 2012
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Pregnancy in Diabetics
Diabetes, Gestational
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on May 22, 2013