Managing Diabetes During Pregnancy in the Wireless Age

N/A

Waitlist Available

Led By Alexander G Logan, MD, FRCP(C)

Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the baseline to the delivery date

Awards & highlights

No Placebo-Only Group

Summary

This Randomized Controlled Trial (RCT) will test the efficacy of a home blood glucose telemonitoring system against usual care in women with gestational diabetes mellitus (GDM) or type 2 diabetes mellitus (T2DM) during pregnancy. We hypothesize that the system can improve glycemic control in patients, assessed using the mean blood glucose during gestation as the primary outcome measure.

Eligible Conditions

Gestational Diabetes
Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for the duration of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for the duration of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and for the duration of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean blood glucose, based on the highest post-prandial blood glucose reading for each day, by trimester

Secondary study objectives

Adherence: Average number of values per day

Adherence: Percentage of values recorded over expected number of values

Fetal outcomes: gestational age at delivery, birth weight (by gender), percentage of macrosomia, large for gestational age (LGA) and small for gestational age (SGA), APGAR at 1 and 5 minutes

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