The DIAMIND study: postpartum SMS reminders to women who have had gestational diabetes mellitus to test for type 2 diabetes: a randomised controlled trial – study protocol

BMC Pregnancy and Childbirth

Caroline Crowther¹  William Hague²  Philippa Middleton²  Emer Heatley² 

[1] The Liggins Institute The University of Auckland, Private Bag 92019, Victoria Street West, Auckland 1142, New Zealand;Australian Research Centre for Health of Women and Babies, Robinson Institute, The University of Adelaide, 72 King William Road North, Adelaide, SA 5006, Australia

关键词: Type 2 diabetes mellitus;    Oral glucose tolerance test;    Postpartum care;    Randomised controlled trial;    SMS text reminder;    Reminder system;    Gestational diabetes mellitus;   

Others  :  1138088
DOI  :  10.1186/1471-2393-13-92

 received in 2013-03-28, accepted in 2013-04-08,  发布年份 2013

【 摘 要 】

Background

Postpartum follow up of women who have been found to have gestational diabetes during pregnancy is essential because of the strong association of gestational diabetes with subsequent type 2 diabetes. Postal reminders have been shown to increase significantly attendance for oral glucose tolerance testing postpartum. It is possible that a short message service (text) reminder system may also be effective. This trial aims to assess whether a text message reminder system for women who have experienced gestational diabetes in their index pregnancy will increase attendance for oral glucose tolerance testing within six months after birth.

Methods/Design

Design: Single centre (Women’s and Children’s Hospital, South Australia), parallel group randomised controlled trial.

Inclusion criteria: Women diagnosed with gestational diabetes in their index pregnancy (oral glucose tolerance test with fasting glucose ≥ 5.5 mmol/L and/or two hour glucose ≥ 7.8 mmol/L), with access to a mobile phone, whose capillary blood glucose profile measurements prior to postnatal discharge are all normal (fasting glucose < 6.0 mmol/L, postprandial glucoses < 8.0 mmol/L).

Exclusion criteria: Pregestational diabetes mellitus, triplet/higher order multiple birth or stillbirth in the index pregnancy, requirement for interpreter.

Trial entry and randomisation: Allocation to intervention will be undertaken using a telephone randomisation service (computer-generated random number sequence generation, with balanced variable blocks, and stratification by insulin requirement).

Study groups: Women in the intervention group will receive a text reminder to attend for an oral glucose tolerance test at 6 weeks postpartum, with further reminders at 3 months and 6 months if they do not respond to indicate test completion. Women in the control group will receive a single text message reminder at 6 months postpartum.

Blinding: Baseline data collection will be undertaken blinded. Blinding of participants and blinded collection of primary outcome data will not be possible for this study.

Primary study outcome: Attendance for the oral glucose tolerance test within 6 months postpartum.

Sample size: 276 subjects will be required to show an 18% absolute increase in the rate of attendance (α=0.05 two tailed, β=80%, 5% loss to follow up) from 37% to 55% in the intervention group.

Discussion

Given the heightened risk of impaired glucose tolerance and type 2 diabetes in women who have had gestational diabetes, ensuring the highest possible rate of attendance for postpartum glucose tolerance testing, so that early diagnosis and intervention can occur, is important. A text message reminder system may prove to be an effective method for achieving improved attendance for such testing. This randomised controlled trial will assess whether such a system will increase rates of attendance for postpartum oral glucose tolerance testing in women who have experienced gestational diabetes.

Trial Registration

Australian New Zealand Clinical Trials Registry - ACTRN12612000621819

【 授权许可】

   
2013 Heatley et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Hoffman L, Nolan C, Wilson JD, Oats JJ, Simmons D: Gestational diabetes mellitus–management guidelines. The Australasian diabetes in pregnancy society. Med J Aust 1998, 169(2):93-97.
• [2]AIHW: Diabetes in pregnancy: its impact on Australian women and their babies. Australian Institute of Health and Welfare: Canberra; 2010.
• [3]Kim C, Newton KM, Knopp RH: Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care 2002, 25(10):1862-1868.
• [4]Kim C, Berger DK, Chamany S: Recurrence of gestational diabetes mellitus: a systematic review. Diabetes Care 2007, 30(5):1314-1319.
• [5]Lee AJ, Hiscock RJ, Wein P, Walker SP, Permezel M: Gestational diabetes mellitus: clinical predictors and long-term risk of developing type 2 diabetes: a retrospective cohort study using survival analysis. Diabetes Care 2007, 30(4):878-883.
• [6]Bottalico JN: Recurrent gestational diabetes: risk factors, diagnosis, management, and implications. Semin Perinatol 2007, 31(3):176-184.
• [7]Bellamy L, Casas JP, Hingorani AD, Williams D: Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet 2009, 373(9677):1773-1779.
• [8]Meltzer S, Leiter L, Daneman D, Gerstein HC, Lau D, Ludwig S, Yale JF, Zinman B, Lillie D: Clinical practice guidelines for the management of diabetes in Canada. Canadian Diabetes Association. CMAJ 1998, 159(Suppl 8):1-29.
• [9]Simmons DS, Walters BN, Wein P, Cheung NW: Guidelines for the management of gestational diabetes mellitus revisited. Med J Aust 2002, 176(7):352.
• [10]South Australian Perinatal Practice Guidelines - Chapter 65 Diabetes mellitus and abnormal glucose tolerance[http://www.health.sa.gov.au/ppg/Default.aspx?PageContentID=2116&tabid=100] webcite
• [11]ACOG: ACOG Committee Opinion No. 435: postpartum screening for abnormal glucose tolerance in women who had gestational diabetes mellitus. Obstet Gynecol 2009, 113(6):1419-1421.
• [12]Metzger BE, Buchanan TA, Coustan DR, de Leiva A, Dunger DB, Hadden DR, Hod M, Kitzmiller JL, Kjos SL, Oats JN: Summary and recommendations of the Fifth International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care 2007, 30(Suppl 2):S251-260.
• [13]Standards of medical care in diabetes--2013 Diabetes Care 2013, 36(1):11-66.
• [14]Ali S, Dornhorst A: Diabetes in pregnancy: health risks and management. Postgrad Med J 2011, 87(1028):417-427.
• [15]Feig DS: Avoiding the slippery slope: preventing the development of diabetes in women with a history of gestational diabetes. Diabetes Metab Res Rev 2012, 28(4):317-320.
• [16]Herman WH: The economics of diabetes prevention. Med Clin North Am 2011, 95(2):373-384. viii
• [17]Tovar A, Chasan-Taber L, Eggleston E, Oken E: Postpartum screening for diabetes among women with a history of gestational diabetes mellitus. Preventing chronic disease 2011, 8(6):A124.
• [18]Reinblatt SL, Morin L, Meltzer SJ: The importance of a postpartum 75 g oral glucose tolerance test in women with gestational diabetes. J Obstet Gynaecol Can 2006, 28(8):690-694.
• [19]Shea AK, Shah BR, Clark HD, Malcolm J, Walker M, Karovitch A, Keely EJ: The effectiveness of implementing a reminder system into routine clinical practice: does it increase postpartum screening in women with gestational diabetes? Chronic diseases in Canada 2011, 31(2):58-64.
• [20]Clark HD, Graham ID, Karovitch A, Keely EJ: Do postal reminders increase postpartum screening of diabetes mellitus in women with gestational diabetes mellitus? A randomized controlled trial. Am J Obstet Gynecol 2009, 200(6):631-637.
• [21]Korpi-Hyovalti E, Laaksonen DE, Schwab U, Heinonen S, Niskanen L: How can we increase postpartum glucose screening in women at high risk for gestational diabetes mellitus? Int J Endocrinol 2012, 2012:519267.
• [22]Lega IC, McLaughlin H, Coroneos M, Handley-Derry F, Donovan N, Lipscombe LL: A physician reminder to improve postpartum diabetes screening in women with gestational diabetes mellitus. Diabetes Res Clin Pract 2012, 95(3):352-357.
• [23]Dietz PM, Vesco KK, Callaghan WM, Bachman DJ, Bruce FC, Berg CJ, England LJ, Hornbrook MC: Postpartum screening for diabetes after a gestational diabetes mellitus-affected pregnancy. Obstet Gynecol 2008, 112(4):868-874.
• [24]Vesco KK, Dietz PM, Bulkley J, Bruce FC, Callaghan WM, England L, Kimes T, Bachman DJ, Hartinger KJ, Hornbrook MC: A system-based intervention to improve postpartum diabetes screening among women with gestational diabetes. Am J Obstet Gynecol 2012, 207(4):281-286.
• [25]Chittleborough CR, Baldock KL, Taylor AW, Hague WM, Willson T, Martin W, Wood J, Phillips PJ: Long-term follow-up of women with gestational diabetes mellitus: the South Australian Gestational Diabetes Mellitus Recall Register. Aust N Z J Obstet Gynaecol 2010, 50(2):127-131.
• [26]National Gestational Diabetes Register[http://www.ndss.com.au/en/GD/Diabetes-Register/] webcite
• [27]Australia - Mobile Communications - Statistics and Forecasts [http:/ / www.budde.com.au/ Research/ Australia-Mobile-Communications-Sta tistics-and-Forecasts.html] webcite
• [28]Car J, Gurol-Urganci I, de Jongh T, Vodopivec-Jamsek V, Atun R: Mobile phone messaging reminders for attendance at healthcare appointments. Cochrane Database Syst Rev 2012., 7CD007458
• [29]Chen ZW, Fang LZ, Chen LY, Dai HL: Comparison of an SMS text messaging and phone reminder to improve attendance at a health promotion center: a randomized controlled trial. J Zhejiang Univ Sci B 2008, 9(1):34-38.
• [30]Downer SR, Meara JG, Da Costa AC: Use of SMS text messaging to improve outpatient attendance. Med J Aust 2005, 183(7):366-368.
• [31]Downer SR, Meara JG, Da Costa AC, Sethuraman K: SMS text messaging improves outpatient attendance. Aust Health Rev 2006, 30(3):389-396.
• [32]Stuebe AM, Rich-Edwards JW, Willett WC, Manson JE, Michels KB: Duration of lactation and incidence of type 2 diabetes. JAMA 2005, 294(20):2601-2610.
• [33]Liu B, Jorm L, Banks E: Parity, breastfeeding, and the subsequent risk of maternal type 2 diabetes. Diabetes Care 2010, 33(6):1239-1241.
• [34]Keely E, Clark H, Karovitch A, Graham I: Screening for type 2 diabetes following gestational diabetes: family physician and patient perspectives. Can Fam Physician 2010, 56(6):558-563.