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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
Be between 18 and 65 years old
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

Timeline

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

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 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TelemonitoringExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
127 Previous Clinical Trials
11,143 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
New England Journal of MedicineJournal
Hyperglycemia and Adverse Pregnancy Outcomes
“Hyperglycemia and Adverse Pregnancy Outcomes”. 2008. “Hyperglycemia and Adverse Pregnancy Outcomes”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0707943.
New England Journal of MedicineJournal
Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes
Crowther, Caroline A., Janet E. Hiller, John R. Moss, Andrew J. McPhee, William S. Jeffries, and Jeffrey S. Robinson. 2005. “Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa042973.
clinicaltrials.govStudy
Managing Diabetes During Pregnancy in the Wireless Age
Alexander Gordon Logan 2010. "Managing Diabetes During Pregnancy in the Wireless Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01474525.
All > Aging > Pregnancy
~7 spots leftby May 2025
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