A randomised placebo-controlled trial of the effectiveness of early metformin in addition to usual care in the reduction of gestational diabetes mellitus effects (EMERGE): study protocol.

BACKGROUND: Pregnancies affected by gestational diabetes mellitus (GDM) are associated with an increased risk of adverse maternal and foetal outcomes. Current treatments for GDM involve initial medical nutritional therapy (MNT) and exercise and pharmacotherapy in those with persistent hyperglycaemia. Insulin is considered first-line pharmacotherapy but is associated with hypoglycaemia, excessive gestational weight gain (GWG) and an increased caesarean delivery rate. Metformin is safe in selected groups of women with GDM but is not first-line therapy in many guidelines due to a lack of long-term data on efficacy. The EMERGE trial will evaluate the effectiveness of early initiation of metformin in GDM. METHODS: EMERGE is a phase III, superiority, parallel, 1:1 randomised, double-blind, placebo-controlled trial comparing the effectiveness of metformin versus placebo initiated by 28 weeks (+6 days) plus usual care. Women aged 18-50 years will be recruited. Women with established diabetes, multiple pregnancies, known major congenital malformation or small for gestational age (<10th centile), intolerance or contraindication to the use of metformin, shock or sepsis, current gestational hypertension or pre-eclampsia, significant gastrointestinal problems, congestive heart failure, severe mental illness or galactose intolerance are excluded. INTERVENTION: Immediate introduction of metformin or placebo in addition to MNT and usual care. Metformin is initiated at 500mg/day and titrated to a maximum dose of 2500mg over 10 days. Women are followed up at 4 and 12 weeks post-partum to assess maternal and neonatal outcomes. The composite primary outcome measure is initiation of insulin or fasting blood glucose ≥ 5.1 mmol/L at gestational weeks 32 or 38. The secondary outcomes are the time to insulin initiation and insulin dose required; maternal morbidity at delivery; mode and time of delivery; postpartum glucose status; insulin resistance; postpartum body mass index (BMI); gestational weight gain; infant birth weight; neonatal height and head circumference at delivery; neonatal morbidities (neonatal care unit admission, respiratory distress, jaundice, congenital anomalies, Apgar score); neonatal hypoglycaemia; cost-effectiveness; treatment acceptability and quality of life determined by the EQ5D-5L scale. DISCUSSION: The EMERGE trial will determine the effectiveness and safety of early and routine use of metformin in GDM. TRIAL REGISTRATION: EudraCT Number 2016-001644-19l; NCT NCT02980276 . Registered on 6 June 2017.

The impact of sharing personalised clinical information with people with type 2 diabetes prior to their consultation: A pilot randomised controlled trial.

AIM: To assess the impact of sharing personalised clinical information with people with type 2 diabetes prior to their out-patient consultation on patient involvement during the consultation, diabetes self-management self-efficacy and glycaemic control. METHODS: A pilot three-arm randomised controlled trial. The 'intervention booklet' group received a booklet including personalised clinical information, a 'general information booklet' control group received a booklet with no personalised clinical information and a 'usual care' control group received no written information. RESULTS: 136 people took part. The intervention group were significantly more likely to have shown the booklet to a 'significant other', (48% V 23%, p<0.05), brought the booklet with them to the clinic (85% V 35%, p<0.005) and to refer to the booklet during the consultation (45% V 13%, p<0.005). No significant differences in patient involvement during the consultation, diabetes management self-efficacy or glycaemic control were found between the three groups. CONCLUSIONS: Although participants found it useful to receive their clinical results, no differences were found in the patient outcomes measured. PRACTICE IMPLICATIONS: Further pilot work on the timing of the intervention, who it is targeted at and what outcomes are measured is warranted before proceeding to a full-scale RCT.

A prospective study of risk factors for foot ulceration: the West of Ireland Diabetes Foot Study.

BACKGROUND: This is the first study to examine risk factors for diabetic foot ulceration in Irish general practice. AIM: To determine the prevalence of established risk factors for foot ulceration in a community-based cohort, and to explore the potential for estimated glomerular filtration rate (eGFR) to act as a novel risk factor. DESIGN: A prospective observational study. METHODS: Patients with diabetes attending 12 (of 17) invited general practices were invited for foot screening. Validated clinical tests were carried out at baseline to assess for vascular and sensory impairment and foot deformity. Ulcer incidence was ascertained by patient self-report and medical record. Patients were re-assessed 18 months later. RESULTS: Of 828 invitees, 563 (68%) attended screening. On examination 23-25% had sensory dysfunction and 18-39% had evidence of vascular impairment. Using the Scottish Intercollegiate Guidelines Network risk stratification system we found the proportion at moderate and high risk of future ulceration to be 25% and 11%, respectively. At follow-up 16/383 patients (4.2%) developed a new foot ulcer (annual incidence rate of 2.6%). We observed an increasing probability of abnormal vascular and sensory test results (pedal pulse palpation, doppler waveform assessment, 10 g monofilament, vibration perception and neuropathy disability score) with declining eGFR levels. We were unable to show an independent association between new ulceration and reduced eGFR [Odds ratio 1.01; P = 0.64]. CONCLUSION: Our data show the extent of foot complications in a representative sample of diabetes patients in Ireland. Use of eGFR did not improve identification of patients at risk of foot ulceration.

Tratamiento de la condromalacia patelar con perforaciones tipo Pridie con la nueva guía en "C" de Carriedo / Treatment of chondromalacia patella with Pridie type drills with the new guide in \"C\" of Carriedo

La condromalacia patelar tiene una alta incidencia en México. Debido a que el tratamiento de sus grados avanzados es quirúrgico, se sugiere su realización a través de artroscopía, para lo que se propone una guía en forma de "C" para realizar perforaciones tipo Pridie con un amplio margen de exactitud y seguridad. En esta comunicación se presenta la experiencia obtenida con el uso de la guía en el tratamiento de 55 pacientes con condromalacia patelar