دورية أكاديمية
CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol.
| العنوان: | CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol. |
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| المؤلفون: | Feig, Denice S, Asztalos, Elizabeth, Corcoy, Rosa, De Leiva, Alberto, Donovan, Lois, Hod, Moshe, Jovanovic, Lois, Keely, Erin, Kollman, Craig, McManus, Ruth, Murphy, Kellie, Ruedy, Katrina, Sanchez, J Johanna, Tomlinson, George, Murphy, Helen R, CONCEPTT Collaborative Group |
| بيانات النشر: | Springer Science and Business Media LLC //dx.doi.org/10.1186/s12884-016-0961-5 BMC Pregnancy Childbirth |
| سنة النشر: | 2016 |
| المجموعة: | Apollo - University of Cambridge Repository |
| مصطلحات موضوعية: | Continuous glucose monitoring, Diabetes mellitus type 1, Preconception, Pregnancy, Randomized controlled trial, Adolescent, Adult, Birth Weight, Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Infant, Newborn, Insulin, Monitoring, Ambulatory, Pregnancy Complications, Pregnancy in Diabetics, Research Design, Young Adult |
| الوصف: | BACKGROUND: Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy. METHODS/DESIGN: A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6.5 % to ≤10.0 % (48 to ≤ 86 mmol/mol). Participants will be randomized to either RT-CGM alongside conventional intermittent home glucose monitoring (HGM), or HGM alone. Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase. To be eligible for randomization, a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight (11 pm-7 am) of CGM glucose values are required. Those meeting these criteria are randomized to RT- CGM or HGM. A total of 324 women will be recruited (110 planning pregnancy, 214 pregnant). This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinically relevant 0.5 % difference between groups at 90 % power with 5 % significance. Randomization will stratify for type of insulin treatment (pump or multiple daily injections) and baseline HbA1c. Analyses will be performed according to intention to treat. The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy, and from baseline to 34 weeks gestation during pregnancy. Secondary outcomes include maternal hypoglycemia, CGM time in, above and below target (3.5-7.8 mmol/l), glucose variability measures, maternal and neonatal outcomes. ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/octet-stream; application/pdf |
| اللغة: | English |
| العلاقة: | https://www.repository.cam.ac.uk/handle/1810/260573Test |
| DOI: | 10.17863/CAM.4807 |
| الإتاحة: | https://doi.org/10.17863/CAM.4807Test https://www.repository.cam.ac.uk/handle/1810/260573Test |
| حقوق: | All Rights Reserved ; https://www.rioxx.net/licenses/all-rights-reservedTest/ ; The Author(s). |
| رقم الانضمام: | edsbas.4FA69AFA |
| قاعدة البيانات: | BASE |
| DOI: | 10.17863/CAM.4807 |
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