Effect of Intensive Nutrition Training, Education, and Support Versus Standard Care in Reducing the Need for Insulin Therapy in Gestational Diabetes (INTENSE-GDM): A Randomised Controlled Trial

简要总结

详细描述

Gestational diabetes (GDM) is defined as glucose intolerance with onset or first recognition during pregnancy. The disease is characterized by hyperglycaemia and a marked insulin resistance secondary to placental hormonal release. Risk factors for developing GDM in pregnancy include obesity, excessive gestational weight gain, previous GDM, glucosuria, family history of diabetes, ethnicity, and hypertension. Hyperglycaemia is associated with serious short- and long-term complications for mother and child including delivering large-for-gestational-age (LGA) babies, macrosomia, preterm birth, caesarean section, preeclampsia, birth injury, respiratory distress syndrome, neonatal hypoglycaemia, jaundice, and increased admission to neonatal intensive care unit (NICU). First-line treatment in GDM after diagnosis is dietary therapy including a systematic and detailed dietary assessment to identify relevant areas for adjusting the diet and overall lifestyle. The overall goals with dietary therapy are 1) To provide adequate calories and micro- and macronutrients to meet the needs of pregnancy consistent with maintaining normoglycaemia, 1) To improve glycaemic control; and 3) To secure appropriate gestational weight gain and avoid excessive weekly gestational weight gain. Currently, no evidence exists for specific recommendations concerning the optimal frequency, intensity, or duration of visits with a dietitian for improving maternal, foetal, or neonatal outcomes. National clinical guidelines for treatment of GDM recommends up to three visits with a dietitian depending on the time of diagnosis. However, in the latest national clinical guidelines under review this has been changed to only one visit. In most cases dietary improvements are sufficient to achieve glycaemic goals but around one third of all women with GDM will need insulin therapy at some point during pregnancy. Decision about additional insulin therapy is based on a combination of ultrasound findings and dietary glycemic control as indicated by the blood glucose protocol as assessed by an obstetrician. Insulin therapy can improve glycaemic control and has been shown to be effective in reducing the rate of macrosomia in GDM. But use of insulin during pregnancy is also associated with several clinical implications, increased hospital and medical costs as well as higher costs in relation to delivery, and neonatal care, and personal burden affecting women with GDM. In summary, the most optimal way to deliver dietary therapy to women with GDM is not known. The possibility that intensive dietary therapy may reduce the need for initiating insulin treatment without increasing hospital service costs for these women in comparison with women receiving standard dietary care needs to be explored. The overall objective is to investigate the effectiveness and hospital service costs of implementing an intervention with intensive dietary counselling and support during pregnancy in women with GDM. The INTENSE-GDM trial is a randomised controlled parallel group open-label effectiveness trial including 214 women with GDM. Participants will attend one consultation with a dietitian in the standard care group and up to 5 consultations (including 2 mandatory follow-up visits and 2 optional follow-up visits) with a dietitian in the intensive dietary counselling group. Both groups will receive one end-of-intervention telephone call. The primary endpoint is the percentage of women with GDM treated with insulin therapy in the intervention group and the control group at delivery. Secondary endpoints include maternal endpoints (changes in body weight from referral to delivery, changes in glycaeted hemoglobin A1c from referral to delivery, time to insulin treatment onset, mean prescribed initial and maximal insulin dose, neonatal endpoints (percentage of LGA, small for gestational age, macrosomia new-borns respectively, percentage of new-borns with neonatal hypoglycaemia and percentage of new-borns admitted to NICU). Descriptive/exploratory endpoints include changes in maternal endpoints (percentage of cases of preeclampsia, preterm births, cases of acute and planned caesarean sections), neonatal endpoints (percentage of cases of neonatal jaundice, questionnaires (diabetes diet-related quality of life, well-being, perceived autonomy support and competence in diet and diabetes, treatment satisfaction and physical activity during pregnancy). Hospital costs will be analysed for the two study groups (intensive dietary therapy vs. standard care) including costs from referral with GDM to discharge after delivery divided into the categories 1) outpatient contacts and costs related to the treatment of GDM, 2) delivery costs, 3) inpatient costs after delivery for mother and offspring separately, including NICU costs and 4) total net costs. Additionally, adherence to intervention (number of no shows for planned visits), number and types of visits (face-to-face, video and telephone), changes in dietary intake and adverse events will be recorded.

主要结局

次要结局

• Large for gestational age (LGA)(At delivery, assessed from study completion up to 24 weeks)
• Neonatal hypoglycaemia(From date of randomisation until data of discharge after child delivery, assessed from study completion up to 24 weeks)
• Admission to neonatal intensive care unit (NICU)(From date of randomisation until data of discharge after child delivery, assessed from study completion up to 24 weeks)
• Maternal body weight(From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks)
• Prescribed insulin(From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks)
• Small for gestational age (SGA)(From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks)
• Maternal glycaemic control(From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks)
• Onset of insulin treatment(From date of randomisation until date of first insulin prescription, assessed from study completion up to 24 weeks)
• Macrosomia (birth weight >4,500 g)(From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks)