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Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy (LOIS-P)

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ClinicalTrials.gov Identifier: NCT03761615
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
Harvard University
Mayo Clinic
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Sansum Diabetes Research Institute

Tracking Information
First Submitted Date November 24, 2018
First Posted Date December 3, 2018
Last Update Posted Date April 4, 2019
Actual Study Start Date November 13, 2018
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2019)
Time in range glucose levels as determined by CGM [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
Time in range defined as 63-140 mg/dL as determined by CGM analysis
Original Primary Outcome Measures
 (submitted: November 29, 2018)
Time in range glucose levels as determined by CGM [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
Time in range defined as 63-140 mg/dL as determined by CGM analysis
Change History Complete list of historical versions of study NCT03761615 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 2, 2019)
  • Time spent below target glucose range [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Time spent below target cgm glucose range defined as glucose <63 mg/dL
  • Frequency of severe hypoglycemic events [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Frequency of severe hypoglycemic events, defined as requiring assistance from another, an emergency room visit or treatment with glucagon due to unconsciousness
  • Time spent above target glucose range [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Time spent above target cgm glucose range defined as >140 mg/dL
  • Episodes of clinically significant hyperglycemia [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Episodes of clinically significant hyperglycemia with CGM glucose >180 mg/dL
  • Extent of glucose variability (GV) [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Glucose variability, defined using predetermined metrics of GV
  • Percent of time CGM active [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Percent of time CGM active per day (minutes of use/24 hours)
  • Concordance of CGM data in relation to SMBG data [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Comparison of concordance of CGM data with measured SMBG glucose levels
  • Total daily insulin requirements [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Change in total daily insulin during pregnancy and the postpartum period (units/day)
  • Basal insulin requirements [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Change in basal insulin during pregnancy and the postpartum period (units/day)
  • Insulin-to-carbohydrate ratio changes [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Change in insulin-to-carbohydrate ratio during pregnancy and the postpartum period (units/day)
  • Insulin sensitivity changes [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Change in insulin sensitivity during pregnancy and the postpartum period
  • Carbohydrate consumption [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Change in carbohydrate consumption during pregnancy and the postpartum period (grams/day)
Original Secondary Outcome Measures
 (submitted: November 29, 2018)
  • Time spent below target glucose range [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Time spent below target cgm glucose range defined as glucose <63 mg/dL
  • Frequency of severe hypoglycemic events [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Frequency of severe hypoglycemic events, defined as requiring assistance from another, an emergency room visit or treatment with glucagon due to unconsciousness
  • Time spent above target glucose range [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Time spent above target cgm glucose range defined as >140 mg/dL
  • Episodes of clinically significant hyperglycemia [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Episodes of clinically significant hyperglycemia with CGM glucose >180 mg/dL
  • Extent of glucose variability (GV) [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Glucose variability, defined using predetermined metrics of GV
  • Percent of time CGM active [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Percent of time CGM active per day (minutes of use/24 hours)
  • Concordance of CGM data in relation to SMBG data [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Comparison of concordance of CGM data with measured SMBG glucose levels
  • Total daily insulin requirements [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Change in total daily insulin during pregnancy and the postpartum period (units/day)
  • Basal insulin requirements [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Change in basal insulin during pregnancy and the postpartum period (units/day)
  • Insulin-to-carbohydrate ratio changes [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Change in insulin-to-carbohydrate ratio during pregnancy and the postpartum period (units/day)
  • Insulin sensitivity changes [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Change in insulin sensitivity during pregnancy and the postpartum period
  • Carbohydrate consumption [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Change in carbohydrate consumption during pregnancy and the postpartum period (grams/day)
Current Other Pre-specified Outcome Measures
 (submitted: April 2, 2019)
  • Ketoacidosis [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Episodes of ketoacidosis requiring emergency room or hospital admission
  • Maternal Complications [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Maternal complications including preeclampsia, pregnancy induced hypertension and polyhydramnios
  • Gestational weight gain [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Gestational weight gain
  • Gestational age at delivery [ Time Frame: Immediately at birth ]
    Gestational age at delivery (Weeks)
  • Birth weight of baby [ Time Frame: Immediately at birth ]
    Birth weight of baby (kg)
  • Fetal malformations [ Time Frame: Immediately at birth ]
    Fetal malformations as recorded by obstetrics and noted at delivery
  • LGA [ Time Frame: Immediately at birth ]
    Incidence of Large for Gestational Age based on WHO criteria at time of delivery
  • SGA [ Time Frame: Immediately at birth ]
    Incidence of Small for Gestational Age based on WHO criteria at time of delivery
  • Preterm Birth [ Time Frame: Immediately at birth ]
    Preterm birth (<37 weeks and early preterm < 34 weeks)
  • Neonatal hypoglycemia [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Neonatal hypoglycemia requiring IV dextrose
  • Neonatal NICU stay [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Neonatal NICU stay > 24 hours and indication
  • Method of delivery [ Time Frame: Immediately at birth ]
    Method of delivery and adverse events associated with delivery including shoulder dystocia
  • Mode of delivery [ Time Frame: Immediately at birth ]
    Mode of delivery including induction rates and incidence of primary cesarean section (and indication noted)
  • Length of hospital stay [ Time Frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Length of hospital stay (Days)
Original Other Pre-specified Outcome Measures
 (submitted: November 29, 2018)
  • Ketoacidosis [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Episodes of ketoacidosis requiring emergency room or hospital admission
  • Maternal Complications [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Maternal complications including preeclampsia, pregnancy induced hypertension and polyhydramnios
  • Gestational weight gain [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Gestational weight gain
  • Gestational age at delivery [ Time Frame: Immediately at birth ]
    Gestational age at delivery (Weeks)
  • Birth weight of baby [ Time Frame: Immediately at birth ]
    Birth weight of baby (kg)
  • Fetal malformations [ Time Frame: Immediately at birth ]
    Fetal malformations as recorded by obstetrics and noted at delivery
  • LGA [ Time Frame: Immediately at birth ]
    Incidence of Large for Gestational Age based on WHO criteria at time of delivery
  • SGA [ Time Frame: Immediately at birth ]
    Incidence of Small for Gestational Age based on WHO criteria at time of delivery
  • Preterm Birth [ Time Frame: Immediately at birth ]
    Preterm birth (<37 weeks and early preterm < 34 weeks)
  • Neonatal hypoglycemia [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Neonatal hypoglycemia requiring IV dextrose
  • Neonatal NICU stay [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Neonatal NICU stay > 24 hours and indication
  • Method of delivery [ Time Frame: Immediately at birth ]
    Method of delivery and adverse events associated with delivery including shoulder dystocia
  • Mode of delivery [ Time Frame: Immediately at birth ]
    Mode of delivery including induction rates and incidence of primary cesarean section (and indication noted)
  • Length of hospital stay [ Time Frame: Prior to 16 weeks gestation (enrollment) through up to 6 weeks postpartum ]
    Length of hospital stay (Days)
 
Descriptive Information
Brief Title Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy
Official Title Observational Study of Patient Important Outcomes in Pregnant Patients With Type 1 Diabetes Mellitus on Insulin Pump
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women 18 years of age or older with T1D using an insulin pump
Condition
  • Type 1 Diabetes Mellitus
  • Pregnancy in Diabetics
Intervention Device: Dexcom G6 CGM
All women in the study will be given Dexcom G6 CGM and a study glucometer.
Study Groups/Cohorts 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.
Intervention: Device: Dexcom G6 CGM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 29, 2018)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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):

    • Fasting glucose ≥126 mg/dL
    • Two-hour OGTT glucose ≥200 mg/dL
    • HbA1c ≥6.5% documented
    • Random glucose ≥200 mg/dL with symptoms
    • No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with T1D
  • Criteria for requiring insulin at diagnosis (1 must be met):

    • Participant required insulin at diagnosis and continually thereafter.
    • Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually.
    • Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually.
  • 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:

    • Inpatient psychiatric treatment in the past 6 months
    • Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty
    • Active gastroparesis
    • Abuse of alcohol or recreational drugs
    • Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)
    • Uncontrolled arterial hypertension (Resting diastolic blood pressure >95mmHg and/or systolic blood pressure >160 mmHg) at the time of screening
    • Chronic oral steroid use
  • 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shelly McCrady-Spitzer 507-255-0316 McCradySpitzer.Shelly@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03761615
Other Study ID Numbers 18-007081
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Plan to create a public database of study results per NIH open data policy.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 1 year after study data analysis is complete and results are published.
Responsible Party Sansum Diabetes Research Institute
Study Sponsor Sansum Diabetes Research Institute
Collaborators
  • Harvard University
  • Mayo Clinic
  • Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: 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
PRS Account Sansum Diabetes Research Institute
Verification Date April 2019