Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes

This study has been completed.
Sponsor:
Collaborators:
Tianjin Medical University
Pennington Biomedical Research Center
Information provided by (Responsible Party):
Tianjin Women and Children's Health Center
ClinicalTrials.gov Identifier:
NCT01565564
First received: March 21, 2012
Last updated: June 9, 2015
Last verified: June 2015
Results First Received: May 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Gestational Diabetes Mellitus
Intervention: Behavioral: Shared glycaemic control care within the local three-tier's antenatal care network

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
The Shared Care Arm

Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education

  • Self blood glucose monitoring
  • Insulin therapy if indicated
  • Self blood glucose monitoring
  • Insulin therapy institutions if indicated;
The Usual Care Arm

Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education

  • Self blood glucose monitoring
  • Insulin therapy if indicated
  • Self blood glucose monitoring
  • Insulin therapy institutions if indicated;

Participant Flow:   Overall Study
    The Shared Care Arm     The Usual Care Arm  
STARTED     344     362  
COMPLETED     339     361  
NOT COMPLETED     5     1  
Lost to Follow-up                 5                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
The Usual Care Arm

Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education

  • Self blood glucose monitoring
  • Insulin therapy if indicated
  • Self blood glucose monitoring
  • Insulin therapy institutions if indicated;
The Shared Care Arm

Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education

  • Self blood glucose monitoring
  • Insulin therapy if indicated
  • Self blood glucose monitoring
  • Insulin therapy institutions if indicated;
Total Total of all reporting groups

Baseline Measures
    The Usual Care Arm     The Shared Care Arm     Total  
Number of Participants  
[units: participants]
  361     339     700  
Age  
[units: years]
Mean (Standard Deviation)
  29.7  (3.2)     29.9  (3.5)     29.8  (3.3)  
Gender  
[units: participants]
     
Female     361     339     700  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     0     0     0  
Unknown or Not Reported     361     339     700  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     361     339     700  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     0     0     0  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: Participants]
     
Chinese     361     339     700  
Region of Enrollment  
[units: participants]
     
China     361     339     700  



  Outcome Measures
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1.  Primary:   The Rate of Macrosomia.   [ Time Frame: At the time of birth. ]

2.  Secondary:   The Rate of Pregnancy-induced Hypertension.   [ Time Frame: From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Exclusion of 242 women with GDM diagnosed from 10 Nov 2011 to 31 Jul 2012 due to potential contaminations due to logistic reasons.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Xilin Yang
Organization: Tianjin Medical University
phone: +86 22 83336727
e-mail: yangxilin@tijmu.edu.cn


No publications provided by Tianjin Women and Children's Health Center

Publications automatically indexed to this study:

Responsible Party: Tianjin Women and Children's Health Center
ClinicalTrials.gov Identifier: NCT01565564     History of Changes
Other Study ID Numbers: 2009-02
Study First Received: March 21, 2012
Results First Received: May 21, 2015
Last Updated: June 9, 2015
Health Authority: China: Ministry of Health