ABSTRACT
AIM: To determine whether it was feasible, safe and acceptable for ambulance clinicians to use capillary blood ketone meters for 'high-risk' diabetic ketoacidosis (DKA) recognition and fluid initiation, to inform the need for a full-powered, multi-centre trial. METHODS: Adopting a stepped-wedge controlled design, participants with hyperglycaemia (capillary blood glucose >11.0 mmol/L) or diabetes and unwell were recruited. 'High-risk' DKA intervention participants (capillary blood ketones ≥3.0 mmol/L) received paramedic-led fluid therapy. Participant demographic and clinical data were collated from ambulance and hospital care records. Twenty ambulance and Emergency Department clinicians were interviewed to understand their hyperglycaemia and DKA care experiences. RESULTS: In this study, 388 participants were recruited (Control: n = 203; Intervention: n = 185). Most presented with hyperglycaemia, and incidence of type 1 and type 2 diabetes was 18.5% and 74.3%, respectively. Ketone meter use facilitated 'high-risk' DKA identification (control: 2.5%, n = 5; intervention: 6.5%, n = 12) and was associated with improved hospital pre-alerting. Ambulance clinicians appeared to have a high index of suspicion for hospital-diagnosed DKA participants. One third (33.3%; n = 3) of Control and almost half (45.5%; n = 5) of Intervention DKA participants received pre-hospital fluid therapy. Key interview themes included clinical assessment, ambulance DKA fluid therapy, clinical handovers; decision support tool; hospital DKA management; barriers to hospital DKA care. CONCLUSIONS: Ambulance capillary blood ketone meter use was deemed feasible, safe and acceptable. Opportunities for improved clinical decision making, support and safety-netting, as well as in-hospital DKA care, were recognised. As participant recruitment was below progression threshold, it is recommended that future-related research considers alternative trial designs. CLINICALTRIALS: gov: NCT04940897.
ABSTRACT
We performed an open-label, randomised controlled trial to compare the effects of a very-low-calorie diet (VLCD) vs. moderate energy deficit approach on body weight, body composition, free androgen index (FAI), and metabolic markers in obese women with polycystic ovary syndrome (PCOS). Forty eligible patients were randomly assigned to a VLCD (n = 21) or a conventional energy deficit approach (n = 19) over the same period. After eight weeks, both groups experienced significant weight loss; however, this was greater in the VLCD arm (-10.9% vs. -3.9%, p < 0.0001). There was also a trend towards a reduction in FAI in the VLCD group compared to the energy deficit group (-32.3% vs. -7.7%, p = 0.07). In the VLCD arm, two women (18%) had a biochemical remission of PCOS (FAI < 4); this was not the case for any of the participants in the energy deficit arm. There was a significant within-group increase in the sex-hormone-binding globulin (p = 0.002) and reductions in fasting blood glucose (p = 0.010) and waist to hip ratio (p = 0.04) in the VLCD arm, but not in the energy deficit arm. The VLCD resulted in significantly greater weight reduction and was accompanied by more pronounced improvements in hyperandrogenaemia, body composition, and several metabolic parameters in obese women with PCOS as compared to the energy deficit approach.
