Gestational Diabetes MellitusNCT01565564
Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes
A study of Gestational Diabetes Mellitus, run by Tianjin Women and Children's Health Center at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 948 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All pregnant women who are diagnosed to have GDM.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Women and Children's Health Center
Tianjin, Tianjin Municipality
About this study
Official title: A Randomized Translational Study to Examine the Effects of Shared Care Versus Usual Care in Management of Gestational Diabetes in a Three-tier Prenatal Care Network in Tianjin, China
Research question (s)/hypothesis:
- . The effectiveness of the shared care management of gestational diabetes mellitus;
- . The cost-effectiveness of the shared care management;
- . Its sustainability
Read the 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
- Being tested
- Shared glycaemic control care within the local three-tier's antenatal care network
- Keywords
- Gestational diabetes mellitus, intervention, shared care, pregnancy outcome, macrosomia, pregnancy-induced hypertension
- Medical subject headings
- Diabetes, Gestational, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared glycaemic control care within the local three-tier's antenatal care networkBehavioural
Also called The shared lifestyle intervention arm
- 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;
| Study group | Role | What they receive |
|---|---|---|
| The usual care arm | Active comparator | Not described Receives: Behavioral: Shared glycaemic control care within the local three-tier's antenatal care network |
| The shared care arm | Active comparator | Not described Receives: Behavioral: Shared glycaemic control care within the local three-tier's antenatal care network |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Macrosomia.
Macrosomia is defined as birthweight ≥ 4000 gram.
Measured: At the time of birth.
Secondary outcomes (1)
The Rate of Pregnancy-induced Hypertension.
Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia.
Measured: From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startSep 2010
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 948 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Women and Children's Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University, Pennington Biomedical Research Center
- Responsible party
- Sponsor
- Investigators
- Gongshu Liu, MD, Study chair, Women and Children's Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565564
- Sponsor's protocol ID
- 2009-02
- Status last verified
- Jun 2015
- First submitted
- 21 Mar 2012
- Last updated
- 7 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Li J, Zhang R, Zhang C, Liu G, Li W, Wang H, Qiao Y, Yu Z, Hu G, Chan JCN, Leng J, Yang X. Effects of intensive treatment of Chinese women with gestational diabetes on the risk of offspring being overweight from 3 to 8 years of age. Diabetes Obes Metab. 2024 Sep;26(9):4126-4130. doi: 10.1111/dom.15770. Epub 2024 Jul 15. No abstract available.
PubMed 39010297Li 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.
PubMed 33495293Yang 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.
PubMed 25349017
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Translational Study to Examine the Effects of Shared Care Versus Usual Care in Management of Gestational Diabetes in a Three-tier Prenatal Care Network in Tianjin, China
- ClinicalTrials.gov ID
- NCT01565564
- Acronym / sponsor ID
- 2009-02
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Gestational diabetes mellitus, intervention, shared care, pregnancy outcome, macrosomia, pregnancy-induced hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 948 participants (actual)
- Lead sponsor
- Tianjin Women and Children's Health CenterUniversity, hospital or other
- Collaborators
- Tianjin Medical University, Pennington Biomedical Research Center
- Study start
- Sep 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research question (s)/hypothesis:
- . The effectiveness of the shared care management of gestational diabetes mellitus;
- . The cost-effectiveness of the shared care management;
- . 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."
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The usual care arm | Active comparator | Behavioral: Shared glycaemic control care within the local three-tier's antenatal care network |
| The shared care arm | Active comparator | Behavioral: Shared glycaemic control care within the local three-tier's antenatal care network |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All pregnant women who are diagnosed to have GDM.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared glycaemic control care within the local three-tier's antenatal care networkAlso: The shared lifestyle intervention arm* 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; | Behavioural | The shared care arm, The usual care arm |
Primary outcome
The Rate of Macrosomia.
Time frame: At the time of birth.
Macrosomia is defined as birthweight ≥ 4000 gram.
1 secondary outcome
The Rate of Pregnancy-induced Hypertension.
Time frame: From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39010297Li J, Zhang R, Zhang C, Liu G, Li W, Wang H, Qiao Y, Yu Z, Hu G, Chan JCN, Leng J, Yang X. Effects of intensive treatment of Chinese women with gestational diabetes on the risk of offspring being overweight from 3 to 8 years of age. Diabetes Obes Metab. 2024 Sep;26(9):4126-4130. doi: 10.1111/dom.15770. Epub 2024 Jul 15. No abstract available.
- Derived from this study: PubMed 33495293Li 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.
- Derived from this study: PubMed 25349017Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gongshu Liu, MD study chair
Women and Children's Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Gestational Diabetes Mellitus, run by Tianjin Women and Children's Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Rate of Macrosomia. (time frame: At the time of birth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01565564, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.