ABSTRACT
AIM: Application of Flash glucose monitoring (FGM) system to evaluate glycaemic variability (GV), patient satisfaction and clinical utility in pregnant women with diabetes. METHODS: This prospective study was conducted in a tertiary care teaching hospital on 70 pregnant women with diabetes where blood sugar levels were monitored by FGM and self-monitoring of blood glucose (SMBG). RESULTS: FGM generated 19,950 readings versus 1470 readings by SMBG over 3 days. Glucose values measured by FGM and SMBG had significant positive correlation (r > 0.89; p < 0.001). Significant difference (p < 0.001) was present between minimum glucose values by FGM (52.49 ± 15.42 mg/dl) and SMBG (72.74 ± 18.30 mg/dl). FGM (20.9%) was able to pick exact duration of hypoglycaemia, while one-third of this duration was missed by conventional SMBG (14.7%; p < 0.05). Hypoglycaemic episodes were observed in 92.9% women by FGM as compared to 45.7% by SMBG (p < 0.001). No significant difference was observed in maximum glucose level or duration of hyperglycaemia by both methods. FGM identified hyperglycaemia in 74% women vs. 52% by SMBG (p < 0.001). GV calculated by using MODD by FGM was 118.4 ± 52.4 mg/dl and by SMBG was 83.2 ± 53.2 mg/dl (p < 0.001). 100% women preferred AGP vs. SMBG. CONCLUSION: This is the first study to evaluate FGM for GV and patient satisfaction in women with GDM. Significant correlation was observed in glucose values by FGM and SMBG. FGM was more sensitive in detecting GV and hypoglycaemic excursions as compared to SMBG. All women preferred FGM over SMBG. Use of FGM gave new insights in clinical management of challenging cases.
ABSTRACT
ObjectivesConvalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. We investigated its effectiveness for the treatment of COVID-19. DesignOpen-label, parallel-arm, phase II, multicentre, randomized controlled trial. SettingThirty-nine public and private hospitals across India. ParticipantsHospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 [≤] 93% on room air). InterventionParticipants were randomized to either control (best standard of care (BSC)) or intervention (CP + BSC) arm. Two doses of 200 mL CP was transfused 24 hours apart in the intervention arm. Main Outcome MeasureComposite of progression to severe disease (PaO2/FiO2< 100) or all-cause mortality at 28 days post-enrolment. ResultsBetween 22nd April to 14th July 2020, 464 participants were enrolled; 235 and 229 in intervention and control arm, respectively. Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm [aOR: 1.09; 95% CI: 0.67, 1.77]. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively [aOR) 1.06 95% CI: -0.61 to 1.83]. InterpretationCP was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalizability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19. Trial registrationThe trial was registered with Clinical Trial Registry of India (CTRI); CTRI/2020/04/024775.
