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| Name | Class |
|---|---|
| Harvard University | OTHER |
| Mayo Clinic | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
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The overall goal of this study is to enroll pregnant women with type 1 diabetes and follow their glycemic outcomes prospectively throughout pregnancy and into the post-partum period. The investigators anticipate that when compared to subjects using an Artificial pancreas system (AP) as part of a future protocol, this comparator group of subjects undergoing usual care will exhibit less time in target continuous glucose monitoring (CGM) glucose range defined as 63-140 mg/dL and an increased duration of hypoglycemia with CGM glucose <63 mg/dL.
This is an observational study. Data collected will include records of continuous glucose monitoring (CGM) based glucose, insulin delivery, self-monitoring of blood glucose (SMBG), and maternal and fetal outcomes from pregnant women with type 1 diabetes. These data will be used to: (1) develop and refine algorithms for an AP system tailored to the needs of pregnant women with type 1 diabetes, (2) to serve as a comparator group for concurrent AP protocols, (3) describe Dexcom G6 CGM data throughout the pregnancy, and (4) describe insulin changes which occur in pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| type 1 diabetes and pregnancy | Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 CGM | Device | All women in the study will be given Dexcom G6 CGM and a study glucometer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM | Time in range defined as 63-140 mg/dL as determined by CGM analysis | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Percentage of Time Spent Below Target Glucose (<63 mg/dL) as Determined by CGM | Time spent below target cgm glucose range defined as glucose <63 mg/dL | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
| Percentage of Time Spent Above Target Glucose Range (> 140 mg/dL) as Determined by CGM |
| Measure | Description | Time Frame |
|---|---|---|
| Ketoacidosis | Episodes of ketoacidosis requiring emergency room or hospital admission | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
| Maternal Complications | Maternal complications including preeclampsia, pregnancy induced hypertension and polyhydramnios |
Inclusion Criteria:
Clinical diagnosis, based on investigator assessment, of T1D for at least one year and using insulin for at least 1 year.
Criteria for documented hyperglycemia (at least 1 must be met):
Criteria for requiring insulin at diagnosis (1 must be met):
Currently using an insulin pump for diabetes management
Currently using or willing to use an insulin-to-carbohydrate ratio to calculate meal bolus sizes
Willing to change insulin infusion site at least every 3 days.
Confirmed pregnancy
Current gestational age <17 weeks
Age 18-40 years
HbA1c <10.0%
Demonstration of proper mental status and cognition for the study
Ability to access the internet and upload CGM data remotely if needed
An understanding of and willingness to follow the protocol and sign the informed consent
Exclusion Criteria:
670 G users in Auto mode
Current gestational age ≥17 weeks
Cystic fibrosis
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
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Pregnant women 18 years of age or older with T1D using an insulin pump
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| Name | Affiliation | Role |
|---|---|---|
| Eyal Dassau, PhD | Harvard University | Principal Investigator |
| Carol Levy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Yogish C Kudva, MD | Mayo Clinic | Principal Investigator |
| Jordan E Pinsker, MD | Sansum Diabetes Research Institute | Principal Investigator |
| Barak Rosenn, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Kristin Castorino, DO | Sansum Diabetes Research Institute | Principal Investigator |
| Grenye O'Malley, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34270347 | Result | O'Malley G, Ozaslan B, Levy CJ, Castorino K, Desjardins D, Levister C, McCrady-Spitzer S, Church MM, Kaur RJ, Reid C, Kremers WK, Doyle FJ, Trinidad MC, Rosenn B, Pinsker JE, Kudva YC, Dassau E. Longitudinal Observation of Insulin Use and Glucose Sensor Metrics in Pregnant Women with Type 1 Diabetes Using Continuous Glucose Monitors and Insulin Pumps: The LOIS-P Study. Diabetes Technol Ther. 2021 Dec;23(12):807-817. doi: 10.1089/dia.2021.0112. Epub 2021 Aug 17. | |
| 35349353 |
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Plan to create a public database of study results per NIH open data policy.
1 year after study data analysis is complete and results are published.
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| ID | Title | Description |
|---|---|---|
| FG000 | Type 1 Diabetes and Pregnancy | Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pregnant women with preexisting T1D for at least 1 year were enrolled before 17 weeks gestational age.
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| ID | Title | Description |
|---|---|---|
| BG000 | Type 1 Diabetes and Pregnancy | Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM | Time in range defined as 63-140 mg/dL as determined by CGM analysis | Posted | Mean | Standard Deviation | percentage of time | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
|
|
During pregnancy, up to 39 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 | Type 1 Diabetes and Pregnancy | Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hypoglycemia | Endocrine disorders | SNOMED CT | Systematic Assessment | Severe hypoglycemia with possible seizures |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gestational hypertension | Pregnancy, puerperium and perinatal conditions | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristin Castorino | Sansum Diabetes Research Institute | 805-682-7638 | info@sansum.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2019 | Dec 10, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 23, 2020 | Dec 10, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D011254 | Pregnancy in Diabetics |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Time spent above target cgm glucose range defined as >140 mg/dL |
| Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
| Episodes of Clinically Significant Hyperglycemia | Episodes of clinically significant hyperglycemia with CGM glucose >180 mg/dL | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
| Total Daily Insulin Requirements Over Last 2 Weeks of Third Trimester | Total daily insulin requirements (units/kg/day) over last 2 weeks of third trimester | 2 weeks |
| Basal Insulin Requirements Over Last 2 Weeks of Third Trimester | Basal daily insulin requirements (units/kg/day) over last 2 weeks of third trimester | 2 weeks |
| Carbohydrate Consumption Over Last 2 Weeks of Third Trimester | Carbohydrate consumption (g/(kg*day)) over last 2 weeks of third trimester | 2 weeks |
| Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
| Gestational Weight Gain | Gestational weight gain each week | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
| Gestational Age at Delivery | Gestational age at delivery (Weeks) | Immediately at birth |
| Birth Weight of Baby | Birth weight of baby (kg) | Immediately at birth |
| LGA | Number of Large for Gestational Age based on WHO criteria at time of delivery | Immediately at birth |
| Preterm Birth | Number of infants born late preterm birth (at 34-37 weeks) | Immediately at birth |
| Neonatal NICU Stay | Number of infants requiring neonatal NICU stay | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
| Cesarean Delivery | Number of participants that underwent primary cesarean section for delivery | Immediately at birth |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Result |
| Kaur RJ, Smith BH, Ozaslan B, Pinsker JE, Trinidad MC, O'Malley G, Desjardins D, Castorino KN, Levister C, Reid C, McCrady-Spitzer S, Ogyaadu SJ, Church MM, Piper M, Kremers WK, Rosenn B, Doyle FJ 3rd, Dassau E, Levy CJ, Kudva YC. Hypoglycemia in Prospective Multicenter Study of Pregnancies with Pre-Existing Type 1 Diabetes on Sensor-Augmented Pump Therapy: The LOIS-P Study. Diabetes Technol Ther. 2022 Aug;24(8):544-555. doi: 10.1089/dia.2021.0479. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational Age at Enrollment | Mean | Standard Deviation | weeks |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Percentage of Time Spent Below Target Glucose (<63 mg/dL) as Determined by CGM | Time spent below target cgm glucose range defined as glucose <63 mg/dL | Posted | Mean | Standard Deviation | percentage of time | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
|
|
|
| Secondary | Percentage of Time Spent Above Target Glucose Range (> 140 mg/dL) as Determined by CGM | Time spent above target cgm glucose range defined as >140 mg/dL | Posted | Mean | Standard Deviation | percentage of time | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
|
|
|
| Secondary | Episodes of Clinically Significant Hyperglycemia | Episodes of clinically significant hyperglycemia with CGM glucose >180 mg/dL | Posted | Mean | Standard Deviation | episodes | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
|
|
|
| Secondary | Total Daily Insulin Requirements Over Last 2 Weeks of Third Trimester | Total daily insulin requirements (units/kg/day) over last 2 weeks of third trimester | Posted | Mean | Standard Deviation | units/kg/day | 2 weeks |
|
|
|
| Secondary | Basal Insulin Requirements Over Last 2 Weeks of Third Trimester | Basal daily insulin requirements (units/kg/day) over last 2 weeks of third trimester | Posted | Mean | Standard Deviation | units/kg/day | 2 weeks |
|
|
|
| Secondary | Carbohydrate Consumption Over Last 2 Weeks of Third Trimester | Carbohydrate consumption (g/(kg*day)) over last 2 weeks of third trimester | Posted | Mean | Standard Deviation | g/(kg*day) | 2 weeks |
|
|
|
| Other Pre-specified | Ketoacidosis | Episodes of ketoacidosis requiring emergency room or hospital admission | Posted | Mean | Standard Deviation | events during pregnancy | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
|
|
|
| Other Pre-specified | Maternal Complications | Maternal complications including preeclampsia, pregnancy induced hypertension and polyhydramnios | Posted | Mean | Standard Deviation | complications | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
|
|
|
| Other Pre-specified | Gestational Weight Gain | Gestational weight gain each week | Posted | Mean | Standard Deviation | kg/week | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
|
|
|
| Other Pre-specified | Gestational Age at Delivery | Gestational age at delivery (Weeks) | Posted | Mean | Standard Deviation | weeks | Immediately at birth |
|
|
|
| Other Pre-specified | Birth Weight of Baby | Birth weight of baby (kg) | Posted | Median | Inter-Quartile Range | grams | Immediately at birth |
|
|
|
| Other Pre-specified | LGA | Number of Large for Gestational Age based on WHO criteria at time of delivery | Infants delivered | Posted | Count of Participants | Participants | Immediately at birth |
|
|
|
| Other Pre-specified | Preterm Birth | Number of infants born late preterm birth (at 34-37 weeks) | Number of infants delivered preterm late preterm (at 34-37 weeks). | Posted | Number | infants | Immediately at birth |
|
|
|
| Other Pre-specified | Neonatal NICU Stay | Number of infants requiring neonatal NICU stay | Number of infants admitted to NICU | Posted | Number | infants | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum |
|
|
|
| Other Pre-specified | Cesarean Delivery | Number of participants that underwent primary cesarean section for delivery | Posted | Count of Participants | Participants | Immediately at birth |
|
|
|
| 0 |
| 25 |
| 2 |
| 25 |
| 9 |
| 25 |
|
| Preeclampsia | Pregnancy, puerperium and perinatal conditions | SNOMED CT | Systematic Assessment |
|
| Polyhydramnios | Pregnancy, puerperium and perinatal conditions | SNOMED CT | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |