NCT03761615

Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Sansum Diabetes Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus
• Pregnancy in Diabetics

Interventions

Type	Name	Description
DEVICE	Dexcom G6 CGM	All women in the study will be given Dexcom G6 CGM and a study glucometer.

Timeline

• Start date: 2018-11-13
• Primary completion: 2021-06-09
• Completion: 2021-06-09
• First posted: 2018-12-03
• Last updated: 2024-04-12
• Results posted: 2024-04-12

Locations

3 sites across 1 country: United States