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Telemonitoring for Gestational Diabetes
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
patients must be pregnant
diagnosed with gestational diabetes or Type 2 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the baseline to the delivery date
Awards & highlights
Study 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
- Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean blood glucose, based on the highest post-prandial blood glucose reading for each day, by trimester
Secondary outcome measures
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
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TelemonitoringExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention
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Who is running the clinical trial?
Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
123 Previous Clinical Trials
10,857 Total Patients Enrolled
Ontario Ministry of Health and Long Term CareOTHER_GOV
91 Previous Clinical Trials
107,924 Total Patients Enrolled
Alexander G Logan, MD, FRCP(C)Principal InvestigatorMOUNT SINAI HOSPITAL
1 Previous Clinical Trials
182 Total Patients Enrolled
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