Trial Outcomes & Findings for Gestational Diabetes Mellitus Trial (GDM) (NCT NCT00069576)

Results Overview

The composite perinatal outcome included stillbirth, neonatal death, hypoglycemia, hyperbilirubinemia, elevated cordblood C-peptide level, and birth trauma.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7381 participants

Primary outcome timeframe

Delivery through discharge of infant from hospital up to 120 days

Results posted on

2019-07-15

Participant Flow

19,665 pregnant women between 24 weeks 0 days and 30 weeks 6 days gestation with glucose levels greater than or equal to 135mg/dl and less than 200 mg/dl after a 1-hour 50-g glucose loading test were assessed for eligibility in the trial. 500 of the eligible patients consented for teh follow-up study.

Of the women screened, 7,381 consented to participate but 83 did not complete an oral glucose tolerance test. Of the 7,298 women who completed an oral glucose tolerance test, 54 were ineligible, 1,938 were referred for treatment and 4,348 had normal tolerance tests. Thus 958 with abnormal tolerance tests had mild GDM and were randomized.

Participant milestones

Participant milestones
Measure	Nutritional Counseling & Self Blood Glucose Monitoring Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Original Trial STARTED	485	473
Original Trial COMPLETED	460	440
Original Trial NOT COMPLETED	25	33
Follow-up Study at 5-10 Years STARTED	460	440
Follow-up Study at 5-10 Years COMPLETED	264	236
Follow-up Study at 5-10 Years NOT COMPLETED	196	204

Reasons for withdrawal

Reasons for withdrawal
Measure	Nutritional Counseling & Self Blood Glucose Monitoring Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Original Trial Lost to Follow-up	25	33
Follow-up Study at 5-10 Years Not eligible or did not consent	196	204

Baseline Characteristics

Gestational Diabetes Mellitus Trial (GDM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nutritional Counseling & Self Blood Glucose Monitoring n=485 Participants Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment n=473 Participants This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.	Total n=958 Participants Total of all reporting groups
Age, Continuous	29.2 years STANDARD_DEVIATION 5.7 • n=5 Participants	28.9 years STANDARD_DEVIATION 5.6 • n=7 Participants	29.1 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	485 Participants n=5 Participants	473 Participants n=7 Participants	958 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Ethnic Groups · Black	56 Participants n=5 Participants	54 Participants n=7 Participants	110 Participants n=5 Participants
Race/Ethnicity, Customized Ethnic Groups · White	123 Participants n=5 Participants	119 Participants n=7 Participants	242 Participants n=5 Participants
Race/Ethnicity, Customized Ethnic Groups · Asian	22 Participants n=5 Participants	28 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized Ethnic Groups · Hispanic	281 Participants n=5 Participants	265 Participants n=7 Participants	546 Participants n=5 Participants
Race/Ethnicity, Customized Ethnic Groups · Other	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Primigravida	104 Participants n=5 Participants	123 Participants n=7 Participants	227 Participants n=5 Participants
Smoking	38 Participants n=5 Participants	31 Participants n=7 Participants	69 Participants n=5 Participants
Alcohol Use	23 Participants n=5 Participants	11 Participants n=7 Participants	34 Participants n=5 Participants
Body-mass Index at Entry	30.1 kg/m^2 STANDARD_DEVIATION 5.0 • n=5 Participants	30.2 kg/m^2 STANDARD_DEVIATION 5.1 • n=7 Participants	30.1 kg/m^2 STANDARD_DEVIATION 5.0 • n=5 Participants
Glucose level after 50-g glucose-loading test - mg/dL	159.0 mg/dL STANDARD_DEVIATION 15.3 • n=5 Participants	159.7 mg/dL STANDARD_DEVIATION 15.5 • n=7 Participants	159.3 mg/dL STANDARD_DEVIATION 15.4 • n=5 Participants
Duration of gestation randomization	28.8 weeks STANDARD_DEVIATION 1.6 • n=5 Participants	28.9 weeks STANDARD_DEVIATION 1.5 • n=7 Participants	28.8 weeks STANDARD_DEVIATION 1.6 • n=5 Participants
Glucose levels in 3-hr Oral Glucose Tolerance Test (OGTT) -mg/dL Fasting	86.6 mg/Dl STANDARD_DEVIATION 5.7 • n=5 Participants	86.3 mg/Dl STANDARD_DEVIATION 5.7 • n=7 Participants	86.5 mg/Dl STANDARD_DEVIATION 5.7 • n=5 Participants
Glucose levels in 3-hr Oral Glucose Tolerance Test (OGTT) -mg/dL 1-hour	191.8 mg/Dl STANDARD_DEVIATION 21.9 • n=5 Participants	193.4 mg/Dl STANDARD_DEVIATION 19.3 • n=7 Participants	192.6 mg/Dl STANDARD_DEVIATION 20.6 • n=5 Participants
Glucose levels in 3-hr Oral Glucose Tolerance Test (OGTT) -mg/dL 2-hour	173.7 mg/Dl STANDARD_DEVIATION 21.8 • n=5 Participants	173.3 mg/Dl STANDARD_DEVIATION 19.6 • n=7 Participants	173.5 mg/Dl STANDARD_DEVIATION 20.7 • n=5 Participants
Glucose levels in 3-hr Oral Glucose Tolerance Test (OGTT) -mg/dL 3-hour	137.3 mg/Dl STANDARD_DEVIATION 29.0 • n=5 Participants	134.1 mg/Dl STANDARD_DEVIATION 31.5 • n=7 Participants	135.7 mg/Dl STANDARD_DEVIATION 30.2 • n=5 Participants

PRIMARY outcome

Timeframe: Delivery through discharge of infant from hospital up to 120 days

Population: The results of some blood tests were not available either because samples were not obtained or were not obtained according to protocol or because they could not be assayed owing to a laboratory processing error. Data were not available in some cases because some women delivered at outside institutions.

The composite perinatal outcome included stillbirth, neonatal death, hypoglycemia, hyperbilirubinemia, elevated cordblood C-peptide level, and birth trauma.

Outcome measures

Outcome measures
Measure	Nutritional Counseling & Self Blood Glucose Monitoring n=485 Participants Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment n=473 Participants This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Number of Participants With Composite Neonatal Morbidity Composite End Point Total	149 Participants	163 Participants
Number of Participants With Composite Neonatal Morbidity Hypoglycemia	62 Participants	55 Participants
Number of Participants With Composite Neonatal Morbidity Hyperbilirubinemia	43 Participants	54 Participants
Number of Participants With Composite Neonatal Morbidity Elevated cord-blood C-peptide level	75 Participants	92 Participants
Number of Participants With Composite Neonatal Morbidity Stillbirth or Neonatal Death	0 Participants	0 Participants
Number of Participants With Composite Neonatal Morbidity Birth Trauma	3 Participants	6 Participants

PRIMARY outcome

Timeframe: Age 5-10 years

Number of children with BMI ≥ 95th percentile for age and sex. BMI is measured as kg / m\^2. Standards based on the 2000 Centers for Disease Control growth charts.

Outcome measures

Outcome measures
Measure	Nutritional Counseling & Self Blood Glucose Monitoring n=264 Participants Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment n=236 Participants This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex	55 Participants	54 Participants

SECONDARY outcome

Timeframe: From time of randomization through delivery (up to 17 weeks)

Population: There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing

Outcome measures

Outcome measures
Measure	Nutritional Counseling & Self Blood Glucose Monitoring n=477 Participants Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment n=454 Participants This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Number of Neonates Who Were Large for Gestational Age at Delivery	34 Participants	66 Participants

SECONDARY outcome

Timeframe: Assessed at Delivery

Population: There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing

Outcome measures

Outcome measures
Measure	Nutritional Counseling & Self Blood Glucose Monitoring n=477 Participants Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment n=454 Participants This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Number of Neonates With Macrosomia (Birth Weight > 4000 gm)	28 Participants	65 Participants

SECONDARY outcome

Timeframe: Delivery before 37 weeks gestation

Number of preterm deliveries before 37 weeks gestation

Outcome measures

Outcome measures
Measure	Nutritional Counseling & Self Blood Glucose Monitoring n=477 Participants Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment n=455 Participants This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Number Participants Who Delivered Preterm	45 Participants	53 Participants

SECONDARY outcome

Timeframe: Assessed at delivery

Outcome measures

Outcome measures
Measure	Nutritional Counseling & Self Blood Glucose Monitoring n=485 Participants Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment n=473 Participants This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Mean Neonatal Fat Mass at Delivery	427.0 grams Standard Deviation 197.9	464.3 grams Standard Deviation 222.3

SECONDARY outcome

Timeframe: From time of randomization through delivery (up to 17 weeks)

Population: There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing

Birth weight below the 10th percentile

Outcome measures

Outcome measures
Measure	Nutritional Counseling & Self Blood Glucose Monitoring n=477 Participants Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment n=455 Participants This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Number of Neonates Who Were Small for Gestational Age	36 Participants	29 Participants

SECONDARY outcome

Timeframe: Assessed at delivery

Birth weight in grams

Outcome measures

Outcome measures
Measure	Nutritional Counseling & Self Blood Glucose Monitoring n=485 Participants Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment n=473 Participants This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Mean Neonatal Birth Weight	3302 grams Standard Deviation 502.4	3408 grams Standard Deviation 589.4

SECONDARY outcome

Timeframe: Delivery through hospital discharge up to 120 days

Admission to the Neonatal Intensive Care Unit

Outcome measures

Outcome measures
Measure	Nutritional Counseling & Self Blood Glucose Monitoring n=477 Participants Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment n=455 Participants This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Number of Infants Admitted to NICU	43 Participants	53 Participants

SECONDARY outcome

Timeframe: Delivery through hospital discharge up to 120 days

Population: Data was missing for 10 infants in the treatment group and 18 infants in the control group.

Number of neonates who received intravenous glucose treatment at any time from delivery through hospital discharge.

Outcome measures

Outcome measures
Measure	Nutritional Counseling & Self Blood Glucose Monitoring n=475 Participants Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. nutritional counseling self blood glucose monitoring	No Treatment n=455 Participants This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
Number of Neonates Who Received Intravenous Glucose Treatment	25 Participants	31 Participants

SECONDARY outcome

Timeframe: Delivery through hospital discharge up to 120 days

Population: Data was missing for 8 infants in the treatment group and 18 infants in the control group.

Number of neonates who experienced Respiratory Distress Syndrome at any time from delivery through hospital discharge