Trial Outcomes & Findings for Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes (NCT NCT01565564)
NCT ID: NCT01565564
Last Updated: 2015-07-07
Results Overview
Macrosomia is defined as birthweight ≥ 4000 gram.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
948 participants
Primary outcome timeframe
At the time of birth.
Results posted on
2015-07-07
Participant Flow
Participant milestones
| Measure |
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;
|
|---|---|---|
|
Overall Study
STARTED
|
344
|
362
|
|
Overall Study
COMPLETED
|
339
|
361
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
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;
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
Baseline Characteristics
Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes
Baseline characteristics by cohort
| Measure |
The Usual Care Arm
n=361 Participants
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
n=339 Participants
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
n=700 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.7 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
29.9 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
29.8 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
361 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
361 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
361 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
361 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
361 participants
n=5 Participants
|
339 participants
n=7 Participants
|
700 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of birth.Macrosomia is defined as birthweight ≥ 4000 gram.
Outcome measures
| Measure |
The Usual Care Arm
n=361 Participants
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
n=339 Participants
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 Rate of Macrosomia.
|
63 participants
|
38 participants
|
SECONDARY outcome
Timeframe: From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia.
Outcome measures
| Measure |
The Usual Care Arm
n=361 Participants
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
n=339 Participants
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 Rate of Pregnancy-induced Hypertension.
|
16 participants
|
27 participants
|
Adverse Events
The Shared Care Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
The Usual Care Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place