Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      Research question (s)/hypothesis:

        1. . The effectiveness of the shared care management of gestational diabetes mellitus;

        2. . The cost-effectiveness of the shared care management;

        3. . Its sustainability
    

Detailed description: 
      Method (s) Tianjin three-tier antenatal care network established a universal screening
      program for gestational diabetes mellitus (GDM) in 1998 and up to 2008, the screening program
      had screened 115348 pregnant women. GDM will be defined as either fasting plasma glucose (PG)
      ≥5.1 mmol/L or 1-hour PG≥ 10.0 mmol/L or 2-hour PG≥ 8.5 mmol/L after 75 g glucose tolerance
      test. A total of 920 pregnant women who have GDM and agree to participate will be randomly
      assign to have the shared care (diet, physical activity and insulin if indicated) or the
      local usual antenatal care. The sample size has ≥80% power at a 5% type I error to detect the
      difference in the primary endpoint, birth weight ≥4000 gram and the secondary endpoint,
      pregnancy-induced hypertension. Hyperglycemia and other clinical data in the two groups of
      women will be collected during the shared care or the usual care. Logistic regression and
      cost-effectiveness analysis will be used in the data analysis.

      Public health significance: The introduction of the proven management of GDM in Tianjin
      antenatal care network will justify the universal screening for GDM and reduce the rate of
      macrosomic infants and reduce pregnancy-induced hypertension, and thus improve pregnancy
      outcomes of women with GDM.

      Sustainability plan: Just as the universal GDM screening in 1998, the shared care model will
      be introduced into the Tianjin antenatal care network as part of the usual care routine after
      the proposed study. The success of the care model will also be publicized and expanded to
      suburban districts and rural counties of Tianjin, possibly other parts of world where
      universal screening for GDM is a routine practice.

      ACKNOWLEDGEMENT This project is supported by a BRIDGES grant from the International Diabetes
      Federation. BRIDGES, an International Diabetes Federation project, is supported by an
      educational grant from Lilly Diabetes."
    

Intervention name(s): Shared glycaemic control care within the local three-tier's antenatal care network
Intervention type(s): Behavioral
Intervention description(s): 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;
Other intervention name(s): The shared lifestyle intervention arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Gestational diabetes mellitus; intervention; shared care; pregnancy outcome; macrosomia; pregnancy-induced hypertension