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CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol

Lookup NU author(s): Dr Malcolm MacDougall, Professor Rudy Bilous, Dr Rasha Mukhtar

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2016 The Author(s). 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. Discussion: This will be the first international multicenter randomized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes. Trial registration: ClinicalTrials.gov Identifier: NCT01788527Registration Date: December 19, 2012.


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Author(s): Feig DS, Asztalos E, Corcoy R, De Leiva A, Donovan L, Hod M, Jovanovic L, Keely E, Kollman C, McManus R, Murphy K, Ruedy K, Sanchez JJ, Tomlinson G, Murphy HR, Feig D, Cleave B, Donat D, Gandhi S, Strom M, Chico AI, Jose Martinez M, Sanchez M, Tundidor D, Amiel S, Hunt K, Green L, Rogers H, Rossi B, Stodhart B, Bonomo M, Bertuzzi F, Corica GD, Fazio S, Giro R, Mion E, Moletta A, Pintaudi B, Sorrentino R, Booth J, McInnes N, Nykamp A, Otto R, Smith A, Stanton I, Tazzeo T, Oldford C, Young C, Gougeon C, Houlden R, Breen A, Castorino K, Sansum W, Keely E, Clark H, Gaudet L, Karovitch A, Malcolm J, Lowe J, Rogowsky A, Kudirka A, Watson M, Morris D, Farnworth F, Fowler D, Mitchell S, Rosier J, Murphy H, Byrne C, Davenport K, Grisoni J, Mulrennan S, Neoh S, O'Sullivan E, Simmons D, Stewart Z, Templin H, Murphy H, Turner J, Canciani G, Hewapathirana N, Jones L, Piper L, Temple R, Wallace T, Maitland R, Banerjee A, Briley A, Brackenridge A, Gilby P, Gill C, Reid A, Singh C, White S, Wolfs M, Scott E, Endersby D, Maresh M, Kearney G, Morris J, Quinn S, Rao-Balakrishna P, MacDougall M, Bilous R, Bilous M, Mahadissu S, Menini D, Mukhtar R, Holt R, Forbes J, Martin N, Walbridge F, Mansell P, Babington G, Bugg G, Gazis T, Jones N, Spick D, Heller S, Bustani R, Gordon V, Madhuvrata P, Hudson S, Nisbet C, Novodvorsky P, Solomon A, Towse K, Philip S, Booth A, Cadzow A, Chlost M, Murray L, Norris K, Shearer K, Dover A, Dougherty F, Johnston S, Little J, McKay L, Lindsay R, Carty D, Crawford I, Mackenzie F, McSorley T, Dunne F, Brosnan E, Conway S, Byrnes MC, Duane L, Duffy N, Egan A, Gaffney G, Higgins G, Kelly C, Kirwan C, Liew A, Normoyle K, Roarty C, Waldron M, Weisnagel J, Allen C, D'Amours M, Dube M-C, Julien V-E, Godbout A, Daigle S, Ransom T, Coolen J, Baxendale D, Newstead-Angel J, Soloman AL, Gorton K, Jackson M, Miller K, Taylor J, Mergler S, Qureshi A, Rodriguez A, Mangoff K

Publication type: Article

Publication status: Published

Journal: BMC Pregnancy and Childbirth

Year: 2016

Volume: 16

Issue: 1

Online publication date: 18/07/2016

Acceptance date: 13/07/2016

Date deposited: 18/04/2017

ISSN (electronic): 1471-2393

Publisher: BioMed Central Ltd.

URL: https://doi.org/10.1186/s12884-016-0961-5

DOI: 10.1186/s12884-016-0961-5


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