Clinical trial NCT03761615: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Pregnancy in Diabetics
Keywords: type 1 diabetes
pregnancy
continues glucose monitoring
artificial pancreas
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: Harvard University
name: Mayo Clinic
name: Icahn School of Medicine at Mount Sinai
First posted: 2018-12-03
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women 18 years of age or older with T1D using an 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.

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

Primary outcomes:
measure: Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM
timeFrame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
Secondary outcomes:
measure: Percentage of Percentage of Time Spent Below Target Glucose (<63 mg/dL) as Determined by CGM
timeFrame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
measure: Percentage of Time Spent Above Target Glucose Range (> 140 mg/dL) as Determined by CGM
timeFrame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
measure: Episodes of Clinically Significant Hyperglycemia
timeFrame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
measure: Total Daily Insulin Requirements Over Last 2 Weeks of Third Trimester
timeFrame: 2 weeks
measure: Basal Insulin Requirements Over Last 2 Weeks of Third Trimester
timeFrame: 2 weeks
measure: Carbohydrate Consumption Over Last 2 Weeks of Third Trimester
timeFrame: 2 weeks
Other outcomes:
measure: Ketoacidosis
timeFrame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
measure: Maternal Complications
timeFrame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
measure: Gestational Weight Gain
timeFrame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
measure: Gestational Age at Delivery
timeFrame: Immediately at birth
measure: Birth Weight of Baby
timeFrame: Immediately at birth
measure: LGA
timeFrame: Immediately at birth
measure: Preterm Birth
timeFrame: Immediately at birth
measure: Neonatal NICU Stay
timeFrame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
measure: Cesarean Delivery
timeFrame: Immediately at birth
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Harvard University
name: Eyal Dassau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Carol Levy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Yogish C Kudva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sansum Diabetes Research Institute
name: Jordan E Pinsker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Barak Rosenn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sansum Diabetes Research Institute
name: Kristin Castorino, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Grenye O'Malley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.