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

NCT ID: NCT01565564

Last Updated: 2015-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 948 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-09-30

Brief 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."

Conditions

Gestational Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

The usual care arm

Group Type: ACTIVE_COMPARATOR

Shared glycaemic control care within the local three-tier's antenatal care network

Intervention Type: BEHAVIORAL

• 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

Group Type: ACTIVE_COMPARATOR

Shared glycaemic control care within the local three-tier's antenatal care network

Intervention Type: BEHAVIORAL

• 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;

Interventions

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;

Intervention Type: BEHAVIORAL

Other Intervention Names

The shared lifestyle intervention arm

Eligibility Criteria

Inclusion Criteria

• All pregnant women who are diagnosed to have GDM.

Exclusion Criteria

• Diagnosis of overt diabetes during OGTT;
• Younger than 18 years of age;
• Non-singleton pregnancy;
• Maternal-foetal ABO blood type incompatibility;
• Maternal diseases such as chronic hypertension,thyrotoxicosis, prepregnancy diabetes and use of long-term medications that may affect glucose metabolism.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University

OTHER

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: collaborator

Tianjin Women and Children's Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gongshu Liu, MD

Role: STUDY_CHAIR

Women and Children's Health Center

Locations

Tianjin Women and Children's Health Center

Tianjin, Tianjin Municipality, China

Countries

China

References

Li J, Liu J, Zhang C, Liu G, Leng J, Wang L, Li W, Yu Z, Hu G, Chan JCN, Yang X. Effects of Lifestyle Intervention of Maternal Gestational Diabetes Mellitus on Offspring Growth Pattern Before Two Years of Age. Diabetes Care. 2021 Mar;44(3):e42-e44. doi: 10.2337/dc20-2750. Epub 2021 Jan 25. No abstract available.

Reference Type: DERIVED

PMID: 33495293 (View on PubMed)

Yang X, Tian H, Zhang F, Zhang C, Li Y, Leng J, Wang L, Liu G, Dong L, Yu Z, Hu G, Chan JC. A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes. J Transl Med. 2014 Oct 28;12:290. doi: 10.1186/s12967-014-0290-2.

Reference Type: DERIVED

PMID: 25349017 (View on PubMed)

Other Identifiers

2009-02

Identifier Type: -

Identifier Source: org_study_id