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Self-monitoring glucose helped recover hypoglycemia awareness in longstanding type 1 diabetes
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In patients with type 1 diabetes, conventional multiple daily injections and self-monitoring of blood glucose can improve hypoglycemia awareness and prevent ongoing severe hypoglycemia without compromising overall metabolic control, according to data from the HypoCompass study.
In a 24-week multicenter study at five UK diabetes referral centers, researchers evaluated 96 patients (ages 18 to 74 years) with c-peptide-negative type 1 diabetes. The mean duration of diabetes among the patients was 29 years. All participants were determined to have impaired awareness of hypoglycemia (IAH) based on a Gold score ≥4. Before the participants were randomly assigned to a regimen, they attended a 1- to 2-hour educational session on the prevention of biochemical hypoglycemia without relinquishing metabolic control.
Participants were then randomly assigned to one of four groups: multiple daily injections (MDI) with self-monitoring of blood glucose (SMBG); MDI with SMBG and real-time continuous glucose measurements (RT-CGM); insulin delivery via continuous subcutaneous insulin infusion (CSII) pumps with SMBG; or CSII with SMBG and RT-CGM.
The researchers found that there was an overall decrease in biochemical hypoglycemia (≤3.0 mmol/L) among the patients (53 ± 63 to 24 ± 56 min/24 hours; P=.004) with no reduction of HbA1c control. There was also an improvement in hypoglycemia awareness (5.1 ± 1.1 to 4.1 ± 1.6; P=.0001) with decreased severe hypoglycemia (SH) (8.9 ± 13.4 to 0.8 ± 1.8 episodes/patient-year; P=0.0001). At the study’s conclusion at 24 weeks, the researchers noted no significant difference in hypoglycemia awareness between the CSII and MDI groups (4.1 ± 1.6 vs. 4.2 ± 1.7; difference 0.1; 95% CI, −0.6 to 0.8) or the RT with SMBG groups (4.3 ± 1.6 vs. 4.0 ± 1.7; difference −0.3; 95% CI, −1.0 to 0.4). Throughout the course of the study, the groups achieved comparable decreases in SH, fear of hypoglycemia, and insulin doses with commensurate HbA1c. There was, however, a higher level of treatment satisfaction among those utilizing CSII vs. MDI patients (32 ± 3 vs. 29 ± 6; P=.0003), which was comparable with SMBG and RT (30 ± 5 vs. 30 ± 5; P=.79).
According to the researchers, additional findings of this study are forthcoming at the two-year follow-up.
“Restoration of hypoglycemia awareness and prevention of SH, without worsening overall metabolic control, can be achieved with conventional MDI and SMBG,” researchers wrote. “Sustainability of benefit will be determined at two years after trial commencement, following return to routine clinical care on completion of the 24-week randomized clinical trial.”
Disclosure: Please see the full study for a list of relevant financial disclosures.
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