Outcomes
palpitations, pain, headache, nausea,, stomach ache, hyperglycaemia, hypoglycaemia
ADVERSE EVENTS, ADVERSE EVENT, SECONDARY, HYPERGLYCAEMIA, HYPOGLYCAEMIA
The primary outcome of the trial was the percentage of CGM-derived time in range (3.9–10.0 mmol/l) during each 2 week period. Secondary glycaemic outcomes included percentage of time below (<3.9 mmol/l) and above (>10.0 mmol/l) range, coefficient of variation and the following event-based outcomes: percentage of cases with successful hypoglycaemia treatment (initial sensor glucose [SG] ≤3.9 mmol/l followed by SG >3.9 mmol/l 30 min post treatment), successful hypoglycaemia treatment without subsequent hyperglycaemia (SG >10 mmol/l within the first 2 h post treatment), successful hypoglycaemia prevention (initial SG >3.9 mmol/l followed by ≤15 consecutive minutes of hypoglycaemia within the first 2 h post treatment), time from hypoglycaemia (<3.9 mmol/l) treatment to euglycaemia (≥3.9 mmol/l) and the incidence rate of supplement carbohydrate administration during the first hour after dasiglucagon administration. Other secondary outcomes included total daily carbohydrate intake, total daily insulin dose and the following participant-reported outcome (PRO): using a four-point Likert scale (very likely, likely, unlikely, very unlikely), participants answered the question, ‘How likely is it that you, given the option, would include dasiglucagon as part of your routine hypoglycaemia management?’ (with ‘very likely’ and ‘likely’ being defined as favourable outcomes). Adverse event outcomes included number of questionnaire-derived adverse events (nausea, headache, stomach ache, palpitations, injection site pain), investigational device failures/malfunctions and serious adverse events.