Heinemann L, et al. - Researchers performed this study in order to investigate if a reduction could be achieved in the incidence and severity of hypoglycaemia by using real-time continuous glucose monitoring (rtCGM) in high-risk individuals with type 1 diabetes treated with multiple daily insulin injections (MDI). Data demonstrated that the incidence of hypoglycaemic events decreased by 72% in the rtCGM group. The inference drawn was that the number of hypoglycaemic events was reduced due to use of rtCGM in individuals with type 1 diabetes treated by MDI and with impaired hypoglycaemia awareness or severe hypoglycaemia.

Methods

• The design of this HypoDE study was a 6-month, multicentre, open-label, parallel, randomised controlled trial.
• It was performed at 12 diabetes practices in Germany.
• The enrollment comprised of patients with type 1 diabetes and a history of impaired hypoglycaemia awareness or severe hypoglycaemia during the previous year.
• Enrollees wore a masked rtCGM system for 28 days and were randomly allocated to 26 weeks of unmasked rtCGM (Dexcom G5 Mobile system) or to the control group (continuing with self-monitoring of blood glucose).
• Herein, block randomisation with 1:1 allocation was conducted centrally, with the study site as the stratifying variable.
• Masking of participants and study sites did not appear to be possible.
• During this trial, control group wore a masked rtCGM system during the follow-up phase (weeks 22–26).
• The baseline-adjusted number of hypoglycaemic events (defined as glucose ≤3·0 mmol/L for ≥20 min) during the follow-up phase served as the primary outcome.
• The full dataset analysis included candidates who wore the rtCGM system during the baseline and follow-up phases.
• The intention-to-treat analysis involved all randomised participants.

Results

• A total of 149 subjects were randomly assigned (n=74 to the control group; n=75 to the rtCGM group) and 141 completed the follow-up phase (n=66 in the control group, n=75 in the rtCGM group) between March 4, 2016, and Jan 12, 2017.
• A reduction was noted in the mean number of hypoglycaemic events per 28 days among enrollees in the rtCGM group from 10.8 (SD 10.0) to 3.5 (4.7).
• Findings illustrated negligible reductions among control cohort (from 14.4 [12.4] to 13.7 [11.6]).
• A 72% decrease was revealed in the incidence of hypoglycaemic events for subjects in the rtCGM group (incidence rate ratio 0·28 [95% CI 0.20-0.39], p < 0.0001).
• Experts found 18 serious adverse events: 7 in the control group, 10 in the rtCGM group, and 1 before randomisation.
• No correlation was discovered between any event with the investigational device.