Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy

Type 1 Diabetes Mellitus Clinical Trial

— LOIS-P  

Official title:

Observational Study of Patient Important Outcomes in Pregnant Patients With Type 1 Diabetes Mellitus on Insulin Pump

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761615
• Other study ID #: 18-007081
• Status: Completed
• Start date: November 13, 2018
• Est. completion date: June 9, 2021

Study information

• Verified date: October 2023
• Source: Sansum Diabetes Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 9, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Pregnancy in Diabetics
• Type 1 Diabetes Mellitus

Intervention

Device:
• Dexcom G6 CGM
All women in the study will be given Dexcom G6 CGM and a study glucometer.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (4)

Lead Sponsor	Collaborator
Sansum Diabetes Research Institute	Harvard University, Icahn School of Medicine at Mount Sinai, Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Prospect — View 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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ketoacidosis	Episodes of ketoacidosis requiring emergency room or hospital admission	Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
Other	Maternal Complications	Maternal complications including preeclampsia, pregnancy induced hypertension and polyhydramnios	Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
Other	Gestational Weight Gain	Gestational weight gain each week	Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
Other	Gestational Age at Delivery	Gestational age at delivery (Weeks)	Immediately at birth
Other	Birth Weight of Baby	Birth weight of baby (kg)	Immediately at birth
Other	LGA	Number of Large for Gestational Age based on WHO criteria at time of delivery	Immediately at birth
Other	Preterm Birth	Number of infants born late preterm birth (at 34-37 weeks)	Immediately at birth
Other	Neonatal NICU Stay	Number of infants requiring neonatal NICU stay	Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
Other	Cesarean Delivery	Number of participants that underwent primary cesarean section for delivery	Immediately at birth
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	Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
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	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	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	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	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	2 weeks
Secondary	Carbohydrate Consumption Over Last 2 Weeks of Third Trimester	Carbohydrate consumption (g/(kg*day)) over last 2 weeks of third trimester	2 weeks