Little SA, et al. - This trial assessed if improved awareness and reduced severe hypoglycemia, achieved during an intensive randomized clinical trial (RCT), were sustained after return to routine care in adults with type 1 diabetes (29 ± 12 years’ duration) and impaired awareness of hypoglycemia at five U.K. tertiary referral diabetes centers. Data recommended offering optimized insulin replacement and glucose monitoring underpinned by hypoglycemia-focused structured education to all with type 1 diabetes complicated by impaired awareness of hypoglycemia.

Methods

• The enrollment consisted of 96 adults with type 1 diabetes (29 ± 12 years’ duration) and impaired awareness of hypoglycemia at 5 U.K. tertiary referral diabetes centers.
• The design of this research was a 24-week 2 × 2 factorial RCT (HypoCOMPaSS).
• Randomization of enrollees was done to pump (continuous subcutaneous insulin infusion [CSII]) or multiple daily injections (MDIs) and real-time continuous glucose monitoring (RT-CGM) or self-monitoring of blood glucose (SMBG), with equal education/attention to all groups.
• Candidates returned to routine care at 24 weeks with follow-up until 24 months, including free choice of MDI/CSII; RT-CGM vs SMBG comparison continued to 24 months.
• Mean difference (baseline to 24 months [between groups]) in hypoglycemia awareness served as the primary outcome.

Results

• Sustained improvement in hypoglycemia awareness was reported (Gold score at baseline 5.1 ± 1.1 vs 24 months 3.7 ± 1.9; P < 0.0001).
• Data disclosed a reduction in the severe hypoglycemia rate from 8.9 ± 12.8 episodes/person-year over the 12 months prestudy to 0.4 ± 0.8 over 24 months (P < 0.0001).
• Improvement was illustrated in HbA1c (baseline 8.2 ± 3.2% [66 ± 12 mmol/mol] vs 24 months 7.7 ± 3.1% [61 ± 10 mmol/mol]; P=0.003).
• Findings also revealed that improvement in treatment satisfaction and the reduced fear of hypoglycemia were sustained.
• No major variations were determined between interventions at 24 months.