medwireNews: Follow-up of the HypoCOMPaSS trial shows that the improvements achieved from a brief hypoglycemia awareness intervention and 6 months of regular support remain apparent 2 years after baseline.
All 96 patients originally enrolled in the trial had type 1 diabetes and impaired hypoglycemia awareness (Gold score ≥4). They underwent a single 1–2 hour hypoglycemia education session and received support via 4-weekly follow-up visits for the duration of the 24-week trial.
Gold scores fell from an average of 5.1 to 4.1 during this period, and they declined a little more among the 76 patients available for follow-up at 24 months, to 3.7. Likewise, the annualized rate of severe hypoglycemic episodes per person–year fell from 8.9 at baseline to 0.8 after the initial follow-up and 0.7 at 24 months.
Patients’ total daily insulin dose decreased from 0.64 to 0.53 µ/kg during the first 24 weeks and remained at 0.54 µ/kg at the end of follow-up.
“It is striking that substantial reductions in total daily insulin dose were observed throughout the current 24-month study without any protocol-driven insulin dose titration regimen beyond [the initial 24-weeks],” say James Shaw (Newcastle University, UK) and co-researchers.
Furthermore, the reduced insulin dose was not accompanied by increased glycated hemoglobin levels. Instead, these fell significantly across the full 2 years of follow-up, from 66 to 61 mmol/mol.
This result “confirms that avoiding severe hypoglycemia does not need to be achieved at the expense of higher overall glucose levels,” write the researchers in Diabetes Care.
They caution, however, that the trial lacked a control group that did not receive the hypoglycemia education. It was actually designed to compare treatment modalities in patients with impaired awareness: insulin pump versus injections and continuous glucose monitoring versus self-monitoring. In the event, the education intervention was effective irrespective of treatment modality.
The researchers in particular call attention to the fact that patients randomly assigned to self-monitor their blood glucose achieved outcomes equivalent to that of those assigned to continuous glucose monitoring. They suggest this may reflect their focus on targeted postprandial and 04:00 blood glucose testing, which is “in contrast to standard clinical practice.”
They also highlight that, despite patients’ initial enthusiasm for continuous glucose monitoring for preventing hypoglycemia, more than two-thirds of them had stopped using it by 24 months, yet the initial benefits were maintained.
“HypoCOMPaSS provides further evidence that structured education and support should underpin interventions targeting impaired awareness of hypoglycemia in type 1 diabetes,” concludes the research team.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group
See also:
- Hypoglycemia awareness intervention not cost-effective
- Continuous glucose monitoring hopeful for hypoglycemia unaware patients
- HypoDE: CGM reduces hypoglycemia in high-risk patients using MDI
- CGM may be better than flash for impaired hypoglycemia awareness
- Hypoglycemia improvements seen with flash to CGM switch