CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Dexcom G6 CGMdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03761615
NCT03761615N/ACompleted
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Observational Study of Patient Important Outcomes in Pregnant Patients With Type 1 Diabetes Mellitus on Insulin Pump

Sansum Diabetes Research Institute·observational·Posted Dec 3, 2018·Updated Apr 12, 2024

In Brief

An observational study evaluating Dexcom G6 CGM for Type 1 Diabetes Mellitus and Pregnancy in Diabetics. Completed, enrolled 25 participants across 3 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus, Pregnancy in Diabetics
CountriesUnited States
CollaboratorsHarvard University, Mayo Clinic, Icahn School of Medicine at Mount Sinai

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 3, 2018
Enrollment StartNov 13, 2018
Primary CompletionJun 9, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.6 years ago

Interventions

Dexcom G6 CGMdevice

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