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

Type 1 Diabetes Mellitus Clinical Trial

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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03761615
• Study type: Observational
• Source: Sansum Diabetes Research Institute
• Status: Completed
• Start date: November 13, 2018
• Completion date: June 9, 2021