An observational study in Type 1 Diabetes and Pregnancy in Diabetic, sponsored by Ana Braescu. Terminated. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-30.
Sponsored by Ana Braescu · Observational
Hypothesize that co-managing pregnant type 1 diabetics with telemedicine will have at least equivalent outcomes to those managed with standard care. Comparison of outcomes between pregnant type 1 diabetics being co-managed with telemedicine compared to those receiving conventional care will help identify unanswered clinical questions and areas for improvement in regard to standards of care for pregnant type 1 diabetics. The data generated from this analysis will help determine whether telemedicine can be an effective additional means of care for pregnant type 1 diabetic patients.
Few studies have researched the use of telemedicine in the management of type 1 diabetes during pregnancy. These studies are additionally limited due to the number of patients as well as several secondary outcomes reported. Therefore, this study will enroll 100 participants to reach a power of 81.8% with HbA1c as a primary outcome and secondary outcomes related to diabetic management such as frequency of hypoglycemia, antenatal hospital stay (percentage requiring admission, length of stay), miscarriage, cesarean section rates, induction of labor, fetal birth weight, gestational age at birth or preterm birth (\<34 weeks, \<37 weeks), frequency of neonatal hypoglycemia, shoulder dystocia, neonatal death, major and minor anomalies, and neonatal intensive care admission.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 5 is below the median of 121 across 769 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →This is the only study on the registry with Ana Braescu as lead sponsor.
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Maternal glycemic control in Type I Diabetics during pregnancy will be studied by enrolling patients in two different groups: one will be treated with the current standard of care for a type 1 diabetic pregnancy and the other group will receive the same standard of care in addition to utilizing telemedicine communication of glucose and insulin readings during weeks when there are no recommended physician visits. All participants will be monitored throughout their pregnancy and clinical outcomes will be reviewed upon delivery and a 6-week postpartum visit. This study is important in adding to current literature regarding the role of telemedicine in pregnant type 1 diabetic care as it could potentially lead to changes in the current standard care for pregnant type 1 diabetics.
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Exclusion Criteria:
HbA1c, maternal glycemic control
maternal glycemic control during pregnancy as measured by HbA1c
Time frame: first trimester in pregnancy through 6 weeks postpartum
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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