HypoDE: CGM reduces hypoglycemia in high-risk patients using MDI
medwireNews: The HypoDE investigators have reported that use of continuous glucose monitoring (CGM) results in large reductions in hypoglycemia among high-risk patients managing their type 1 diabetes with multiple daily injections (MDI).
Guido Freckmann (University of Ulm, Germany), one of the team that presented the findings at the Advanced Technologies and Treatments in Diabetes conference in Vienna, Austria, noted that although a number of major studies of CGM have been published since the initiation of HypoDE in 2015, none have answered this specific question – whether MDI users at high hypoglycemia risk benefit from CGM.
The researchers recruited patients (mean age around 46 years) who either had a hypoglycemia unawareness score of at least 4 or had experienced a severe hypoglycemic event (requiring third-party assistance) during the preceding 12 months.
All trial participants used a masked CGM system for the first 4 weeks, after which they were randomly assigned to use unmasked CGM or to continue with their usual care for a further 22 weeks. The CGM group continued to use their devices for a further 4 weeks, during which the control group again used masked CGM.
During this last phase, the 75 patients in the CGM group who completed the trial had an average of 3.5 hypoglycemia events, whereas the 66 patients in the control group had an average of 13.7. The corresponding rates during the baseline masked phase were 10.8 and 14.4; this represented a highly significant 72% improvement for the CGM group versus the change in the control group.
The researchers defined a hypoglycemia event as blood glucose at or below 54 mg/dL (3.3 mmol/L) for at least 20 minutes. To count as a single event, it had to be preceded by at least 30 minutes of blood glucose above that threshold.
The CGM group also had a reduction in nocturnal hypoglycemia events, from an average of 2.3 to 1.0 during the baseline and final 4-week phases, whereas the control group had a slight increase, from 2.4 to 2.7.
CGM significantly reduced the time spent in hypoglycemia, but had no effect on time in hyperglycemia or on glycated hemoglobin (HbA1c) levels. However, it significantly improved glycemic variability and some patient-reported outcomes, including patient satisfaction with their treatment and hypoglycemia-related diabetes distress.
Of note, there was a 40% reduction in hypoglycemia unawareness in both groups, which Lutz Heinemann (Science-Consulting in Diabetes GmbH, Düsseldorf, Germany), who presented the metabolic outcomes, suggested implied a general positive effect of taking part in a clinical trial.
The study findings were simultaneously published in The Lancet, along with a commentary by Richard Bergenstal (International Diabetes Center at Park Nicollet, Minneapolis, Minnesota, USA), who describes HypoDE as “the type of study needed to expand the indications for use of CGM in populations with a strong need to improve HbA1c and reduce glucose variability and hypoglycaemia.”
He says that CGM “might be the best example of diabetes precision medicine widely available today,” helping patients and their healthcare providers to “agree on an individualised action plan” to optimize glycemic control.
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