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

Australian Research Centre for Health of Women and Babies, Robinson Institute, The University of Adelaide, 72 King William Road North, Adelaide, SA 5006, Australia. .
BMC Pregnancy and Childbirth (Impact Factor: 2.15). 04/2013; 13:92. DOI: 10.1186/1471-2393-13-92
Source: PubMed

ABSTRACT 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.
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.
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.
Australian New Zealand Clinical Trials Registry - ACTRN12612000621819.

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    ABSTRACT: Type 2 Diabetes Mellitus (T2DM) and Gestational Diabetes (GDM) are important and escalating problems worldwide. GDM increases the risk of complications in pregnancy and birth, as well as a 1 in 2 chance of developing T2DM later in life. The burden of GDM extends to offspring, who have an increased risk of obesity and diabetes—further perpetuating the cycle of diabetes within families. Clinical trial evidence demonstrates T2DM incidence reduced by up to 50% for women with GDM with nutrition and physical activity changes and the economic modeling suggests cost effectiveness. The key diet-related changes to reduce T2DM risk are reviewed, in addition to breastfeeding. The difficulties associated with the delivery of dietary and lifestyle behaviour change to women after GDM are discussed and focus on: complex healthcare system interactions needed for care delivery; women finding postpartum self-care challenging; and low levels of awareness being present across the board. In addition, studies currently underway to improve care provision in this important area will be examined.
    11/2014; DOI:10.3390/healthcare2040468
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    ABSTRACT: Objectives: To explore factors associated with postpartum glucose screening among women with Gestational Diabetes Mellitus (GDM). Methods: A retrospective study using linked records from women with GDM who gave birth at Cairns Hospital in Far North Queensland, Australia, from 1 January 2004 to 31 December 2010. Results: The rates of postpartum Oral Glucose Tolerance Test (OGTT) screening, while having increased significantly among both Indigenous* and non-Indigenous women from 2004 to 2010 (HR 1.15 per year, 95%CI 1.08-1.22, p<0.0001), remain low, particularly among Indigenous women (10% versus 27%, respectively at six months postpartum). Indigenous women in Cairns had a longer time to postpartum OGTT than Indigenous women in remote areas (HR 0.58, 0.38-0.71, p=0.01). Non-Indigenous women had a longer time to postpartum OGTT if they: were born in Australia (HR 0.76, 0.59-1.00, 0.05); were aged <25 years (HR 0.45, 0.23-0.89, p=0.02); had parity >5 (HR 0.33, 0.12-0.90, p=0.03); smoked (HR 0.48, 0.31-0.76, p=0.001); and did not breastfeed (HR 0.09, 0.01-0.64, p=0.02). Conclusions: Postpartum diabetes screening rates following GDM in Far North Queensland are low, particularly among Indigenous women, with lower rates seen in the regional centre; and among non-Indigenous women with indicators of low socioeconomic status. Implications: Strategies are urgently needed to improve postpartum diabetes screening after GDM that reach women most at risk.
    Australian and New Zealand Journal of Public Health 11/2014; 39(1). DOI:10.1111/1753-6405.12285 · 1.90 Impact Factor
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    ABSTRACT: AimsThis parallel group randomized controlled trial assessed whether an SMS reminder system for women, after gestational diabetes, would increase their attendance for an oral glucose tolerance test (OGTT) by six months postpartum.Methods Women were eligible for inclusion if they were diagnosed with gestational diabetes in their recent pregnancy, had a mobile phone and normal blood glucose profile prior to postnatal discharge from the Women's and Children's Hospital, Adelaide. A computer-generated random number sequence and telephone randomization were used. Two hundred and seventy-six women were randomized. Women in the six-week group (n = 140) were sent a text reminder to attend for an OGTT at six weeks postpartum, with further reminders at three and six months if required. Women in the control group (n = 136) received one text reminder at six months postpartum. Blinding was not feasible. The primary outcome was OGTT attendance within six months postpartum.ResultsWomen in the six-week group did not increase their attendance for an OGTT within six months postpartum compared with women in the control group, 104 (77.6% of 134) versus 103 (76.8% of 134), RR 1.01, 95% confidence interval (CI) 0.89–1.15.Conclusions The SMS reminder system did not increase postpartum OGTT, fasting plasma glucose or HbA1c completion, although high rates of test completion were measured in both groups. Further research is required into factors influencing attendance for postpartum testing from the perspective of women, and into optimal counselling relating to Type 2 diabetes risk in the postpartum period for increasing postpartum glucose testing rates.This article is protected by copyright. All rights reserved.
    Diabetic Medicine 03/2015; DOI:10.1111/dme.12769 · 3.06 Impact Factor

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