Trial Outcomes & Findings for Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus (NCT NCT03029702)
NCT ID: NCT03029702
Last Updated: 2024-11-29
Results Overview
Proportion of women who are eligible, screened, enrolled and remain in the study
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
54 participants
Primary outcome timeframe
Through study completion, an average of 16 weeks
Results posted on
2024-11-29
Participant Flow
Participant milestones
| Measure |
Usual Care
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
Individualized Treatment
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Usual Care
n=27 Participants
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
Individualized Treatment
n=27 Participants
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.90 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
30.91 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
30.9 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 16 weeksProportion of women who are eligible, screened, enrolled and remain in the study
Outcome measures
| Measure |
Usual Care
n=27 Participants
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
Individualized Treatment
n=27 Participants
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
|---|---|---|
|
Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study
|
25 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 16 weeksSuitability of the study procedures and interventions to participants assessed through one-on-one qualitative interview
Outcome measures
| Measure |
Usual Care
n=27 Participants
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
Individualized Treatment
n=27 Participants
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
|---|---|---|
|
Proportion of Participants Who Report Suitability of the Study Procedures
|
24 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 2 weeks after treatment initiationOutcome measures
| Measure |
Usual Care
n=27 Participants
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
Individualized Treatment
n=27 Participants
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
|---|---|---|
|
Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation
|
22 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 16 weeksOutcome measures
| Measure |
Usual Care
n=27 Participants
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
Individualized Treatment
n=27 Participants
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
|---|---|---|
|
Proportion of Women Who Remain on Same Treatment During Study
|
25 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Delivery\>50% fasting below 95 and 1 hour postprandial \< 140 during the 4 weeks before delivery
Outcome measures
| Measure |
Usual Care
n=27 Participants
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
Individualized Treatment
n=27 Participants
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
|---|---|---|
|
Maternal Glucose Control
|
20 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: DeliveryOutcome measures
| Measure |
Usual Care
n=27 Participants
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
Individualized Treatment
n=27 Participants
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
|---|---|---|
|
Proportion of Participants Who Deliver by Primary Cesarean
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: DeliveryOutcome measures
| Measure |
Usual Care
n=27 Participants
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
Individualized Treatment
n=27 Participants
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
|---|---|---|
|
Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: DeliveryOutcome measures
| Measure |
Usual Care
n=27 Participants
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
Individualized Treatment
n=27 Participants
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Insulin: Insulin will be used for GDM treatment
Glyburide: Glyburide will be used for GDM treatment
Metformin: Metformin will be used for GDM treatment
|
|---|---|---|
|
Birthweight
|
332.5 g
Standard Deviation 376.7
|
3445.4 g
Standard Deviation 627.2
|
SECONDARY outcome
Timeframe: Within 72 hours of deliveryPopulation: Unable to collect neonatal data due to lack of staffing availability
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: DeliveryPopulation: Samples unavailable for analysis due to freezer storage malfunction
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: DeliveryPopulation: Samples unavailable for analysis due to freezer storage malfunction
Outcome measures
Outcome data not reported
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individualized Treatment
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