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The aim of this study is to compare glycemic control in pregnant women treated with insulin Detemir and pregnant women treated with NPH insulin. These women are diagnosed with gestational diabetes (GDM) in the current pregnancy or have a preexisting diagnosis of type 2 diabetes (T2DM) at the onset of pregnancy. Our hypothesis is that there is no difference between these two treatment modalities in terms of glycemic control in diabetes.
The experimental method will be a randomized controlled trial performed at Roosevelt Hospital in our Diabetes in Pregnancy Program (DIPP). Perinatologists managing the patient in DIPP determine when patients need further treatment with medical therapy. Patients undergoing care at DIPP may require medical intervention in the following clinical scenarios: failure of diet alone to control glycemic indices and grossly abnormal glucose tolerance screening test results suggesting disease of such severity that diet alone would not be sufficient. After verbally counseling the patient, she will be recruited for the study by the investigators. An extensive explanation of the objectives of the study will be presented to the patient, as well as written copies of the protocol and consent. After informed consent is given, patients will be randomized to management with either insulin NPH or detemir together with rapid acting insulin aspart (Novolog) with meals, as necessary. The primary outcome will be level of glycemic control defined as overall mean blood glucose in pregnancy. This is a well established measure of overall glycemic control that has been used in numerous publications in the obstetric literature on diabetes in pregnancy. Participants will be followed until they deliver, with an expected range of 6-16 weeks depending on when the patient was enrolled in the study. The mean glucose will be determined by the sum of average glucose at each visit divided by the number of visits).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levemir | Active Comparator | Initial daily total insulin doses will be determined as per a weight based protocol depending on what trimester the patient is in. Sixty percent of the total daily insulin dose will be allotted to the morning total dose of insulin, while the remaining 40% will be allotted to the evening total dose. Of the morning dose, 2/3 will be allotted to the long acting insulin and 1/3 to short acting insulin. She will take half of the short-acting dose with breakfast and the other half with lunch. The evening insulin dose (40% of the total dose) will be divided in two: half the dose will be taken as short-acting insulin with dinner, and the other half as long acting insulin at bedtime. Doses are rounded down if decimals are present. |
|
| NPH | Active Comparator | Initial daily total insulin doses will be determined as per a weight based protocol depending on what trimester the patient is in. Sixty percent of the total daily insulin dose will be allotted to the morning total dose of insulin, while the remaining 40% will be allotted to the evening total dose. Of the morning dose, 2/3 will be allotted to the long acting insulin and 1/3 to short acting insulin. She will get the entire dose of short-acting insulin with breakfast. The evening insulin dose (40% of the total dose) will be divided in two: half the dose will be taken as short-acting insulin with dinner, and the other half as long acting insulin at bedtime. Doses are rounded down if decimals are present. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | Overall mean glucose value of pregnancy. This will be determined by the sum of average glucose value at each visit, divided by the number of visits. | up to 41 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Obtaining Glycemic Control | Number of each group that obtains glycemic control, defined as mean glucose <100mg/dl. | up to 41 weeks |
| Time to Achieve Glycemic Control | Time (weeks) to achieve glycemic control, as defined as mean glucose <100mg/dl |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's-Roosevelt Hospital Center | New York | New York | 10019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26070699 | Derived | Herrera KM, Rosenn BM, Foroutan J, Bimson BE, Al Ibraheemi Z, Moshier EL, Brustman LE. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol. 2015 Sep;213(3):426.e1-7. doi: 10.1016/j.ajog.2015.06.010. Epub 2015 Jun 9. |
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Women with gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) who entered the Diabetes in Pregnancy Program were recruited from March 2013 through October 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin NPH | Insulin neutral protamine Hagedorn (NPH) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose. |
| FG001 | Levemir | Insulin detemir (IDet) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin NPH | Insulin neutral protamine Hagedorn |
| BG001 | Levemir | Insulin detemir (IDet) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycemic Control | Overall mean glucose value of pregnancy. This will be determined by the sum of average glucose value at each visit, divided by the number of visits. | Posted | Mean | Standard Deviation | mg/dL | up to 41 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin NPH | Insulin neutral protamine Hagedorn | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kimberly M. Herrera | Roosevelt Hospital, Mount Sinai Health System | kimmerher@gmail.com |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D007336 | Insulin, Isophane |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| up to 41 weeks |
| Average Fasting Glucose | Mean fasting blood glucose in pregnancy, as determined by the sum of the mean fasting glucose at each visit divided by the number of visits | up to 41 weeks |
| Post-prandial Blood Glucose | Mean post-prandial blood glucose in pregnancy, as defined as the sum of the average post-prandial blood glucose at each visit divided by the number of visits. | up to 41 weeks |
| Weight Gain | Total weight gain in pregnancy | Number of pounds gained at each visit up to 41 weeks |
| Neonatal Weight | Neonatal weight was estimated for occurrence of neonatal macrosomia (≥4000g birth weight) and neonatal LGA(large for gestational age)(birth weight >90th percentile for gestational age | At delivery, up to 41 weeks |
| Gestational Age at Delivery | Gestational age at delivery | at delivery, up to 41 weeks |
| Maternal Hypoglycemia | Number of participants with incidence of maternal hypoglycemia (<60mg/dl) | at delivery, up to 41 weeks |
| Neonatal Bilirubin | Percentage of neonatal hyperbilirubinemia - data not collected | at birth, up to 41 weeks |
| Intensive Care Admissions | Number of participants with incidence of neonatal intensive care unit admissions | at birth, up to 41 weeks |
| Delivery Mode | method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery - data not collected | at birth, up to 41 weeks |
| Birth Rate | Number of live birth rate | at birth, up to 41 weeks |
| Shoulder Dystocia | Incidence of shoulder dystocia - data not collected | at birth, up to 41 weeks |
| Polyhydramnios | Incidence of polyhydramnios (defined as amniotic fluid index (AFI)>20 or deepest vertical pocket ≥8) - data not collected | at each visit in pregnancy up to 41 weeks |
| Neonatal Hypoglycemia | Number of participants with incidence of blood sugar <40mg/dl in neonate | at birth, up to 41 weeks |
| allergic reaction |
|
| switched to oral hypoglycemic or diet |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| T2DM | Type 2 Diabetes Mellitus | Count of Participants | Participants |
|
| GDM in previous pregnancies | Count of Participants | Participants |
|
| Multiple gestation | Count of Participants | Participants |
|
| Polycystic ovary syndrome | Count of Participants | Participants |
|
| Chronic hypertension | Count of Participants | Participants |
|
| Renal disease | Count of Participants | Participants |
|
| Thyroid disease | Count of Participants | Participants |
|
| Prepregnancy body mass index | Median | Inter-Quartile Range | kg/m^2 |
|
| Prepregnancy body status | Count of Participants | Participants |
|
| Gestational age diagnosed | Median | Inter-Quartile Range | weeks |
|
| Previous management | Count of Participants | Participants |
|
| Gestational age at entry to DIPP | Median | Inter-Quartile Range | weeks |
|
| Gestational age insulin started | Median | Inter-Quartile Range | weeks |
|
| Time between visits | Median | Inter-Quartile Range | weeks |
|
|
|
| Secondary | Number of Patients Obtaining Glycemic Control | Number of each group that obtains glycemic control, defined as mean glucose <100mg/dl. | Posted | Count of Participants | Participants | up to 41 weeks |
|
|
|
| Secondary | Time to Achieve Glycemic Control | Time (weeks) to achieve glycemic control, as defined as mean glucose <100mg/dl | Posted | Median | Full Range | weeks | up to 41 weeks |
|
|
|
| Secondary | Average Fasting Glucose | Mean fasting blood glucose in pregnancy, as determined by the sum of the mean fasting glucose at each visit divided by the number of visits | Posted | Mean | Standard Deviation | mg/dL | up to 41 weeks |
|
|
|
| Secondary | Post-prandial Blood Glucose | Mean post-prandial blood glucose in pregnancy, as defined as the sum of the average post-prandial blood glucose at each visit divided by the number of visits. | Posted | Mean | Standard Deviation | mg/dL | up to 41 weeks |
|
|
|
| Secondary | Weight Gain | Total weight gain in pregnancy | Posted | Mean | Standard Deviation | lbs | Number of pounds gained at each visit up to 41 weeks |
|
|
|
| Secondary | Neonatal Weight | Neonatal weight was estimated for occurrence of neonatal macrosomia (≥4000g birth weight) and neonatal LGA(large for gestational age)(birth weight >90th percentile for gestational age | Posted | Median | Inter-Quartile Range | g | At delivery, up to 41 weeks |
|
|
|
| Secondary | Gestational Age at Delivery | Gestational age at delivery | Posted | Median | Inter-Quartile Range | weeks | at delivery, up to 41 weeks |
|
|
|
| Secondary | Maternal Hypoglycemia | Number of participants with incidence of maternal hypoglycemia (<60mg/dl) | Posted | Count of Participants | Participants | at delivery, up to 41 weeks |
|
|
|
| Secondary | Neonatal Bilirubin | Percentage of neonatal hyperbilirubinemia - data not collected | Posted | at birth, up to 41 weeks |
|
|
| Secondary | Intensive Care Admissions | Number of participants with incidence of neonatal intensive care unit admissions | Posted | Count of Participants | Participants | at birth, up to 41 weeks |
|
|
|
| Secondary | Delivery Mode | method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery - data not collected | Posted | at birth, up to 41 weeks |
|
|
| Secondary | Birth Rate | Number of live birth rate | Posted | Count of Participants | Participants | at birth, up to 41 weeks |
|
|
|
| Secondary | Shoulder Dystocia | Incidence of shoulder dystocia - data not collected | Posted | at birth, up to 41 weeks |
|
|
| Secondary | Polyhydramnios | Incidence of polyhydramnios (defined as amniotic fluid index (AFI)>20 or deepest vertical pocket ≥8) - data not collected | Posted | at each visit in pregnancy up to 41 weeks |
|
|
| Secondary | Neonatal Hypoglycemia | Number of participants with incidence of blood sugar <40mg/dl in neonate | Posted | Count of Participants | Participants | at birth, up to 41 weeks |
|
|
|
| 52 |
| 0 |
| 52 |
| 27 |
| 52 |
| EG001 | Levemir | Insulin detemir (IDet) | 0 | 53 | 0 | 53 | 45 | 53 |
| Symptomatic hypoglycemia | Metabolism and nutrition disorders |
|
| biochemical event of hypoglycemia | Metabolism and nutrition disorders | glucose <60mg/dL regardless of presence or absence of symptoms |
|
| Symptomatic nocturnal event | Metabolism and nutrition disorders |
|
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |