Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open-label, crossover trial

摘要: Summary Background Patients with type 1 diabetes who have impaired awareness of hypoglycaemia a three to six times increased risk severe hypoglycaemia. We aimed assess whether continuous glucose monitoring (CGM) improves glycaemia and prevents compared self-monitoring blood (SMBG) in this high-risk population. Methods did randomised, open-label, crossover trial (IN CONTROL) at two medical centres the Netherlands. Eligible participants were patients diagnosed according American Diabetes Association criteria, aged 18–75 years, as confirmed by Gold score least 4, treated either subcutaneous insulin infusion or multiple daily injections doing SMBG measurements per day. After screening, re-education about management, 6-week run-in phase (to obtain baseline CGM data), we randomly assigned (1:1) computer-generated allocation sequence (block size four) 16 weeks followed 12 washout SMBG, (where was control). During phase, used real-time system consisting Paradigm Veo MiniLink transmitter an Enlite sensor (Medtronic, CA, USA). equipped masked device, iPro 2 monitor sensor, which does not display values. The number day systems standardised between patients, mimic real-life conditions. both intervention periods, attended follow-up visits each month had telephone consultations after visit inquiring adverse events, episodes hypoglycaemia, etc. primary endpoint mean difference percentage time spent normoglycaemia (4–10 mmol/L) over total analysed on intention-to-treat basis. Severe (requiring third party assistance) secondary endpoint. This is registered ClinicalTrials.gov, NCT01787903. Findings Between March 2013, Feb 9, 2015, recruited 52 CGM–SMBG (n=26) SMBG–CGM (n=26). last patient 21, 2016. Time higher during than SMBG: 65·0% (95% CI 62·8–67·3) versus 55·4% (53·1–57·7; 9·6%, 95% 8·0–11·2; p vs 11·4%, 4·7%, 3·4–5·9; 10 mmol/L [28·2% 33·2%, 5·0%, 3·1–6·9; 34 p=0·033). Five serious events other occurred trial, but all deemed unrelated intervention. Additionally, no mild moderate related Interpretation reduced SMBG. Our results support concept using Funding Eli Lilly Sanofi.