AI Article Synopsis
- The HypoCOMPaSS study aimed to see if avoiding biochemical hypoglycemia could help participants with type 1 diabetes regain awareness of hypoglycemia to prevent severe episodes.
- A total of 96 adults with impaired hypoglycemia awareness underwent a 24-week trial, of which 71 were analyzed for severe hypoglycemia recurrence over two years.
- Results showed that complete responders had fewer severe hypoglycemic events and better hypoglycemic awareness compared to incomplete responders, who also demonstrated higher rates of anxiety and peripheral neuropathy.
Article Abstract
Objective: The HypoCOMPaSS study was designed to test the hypothesis that successful avoidance of biochemical hypoglycemia without compromising overall glycemic control would restore sufficient hypoglycemia awareness to prevent recurrent severe hypoglycemia in the majority of participants with established type 1 diabetes. Before starting the study, we planned to investigate associations between baseline characteristics and recurrent severe hypoglycemia over 2 years' follow-up.
Research Design And Methods: A total of 96 adults with type 1 diabetes and impaired awareness of hypoglycemia participated in a 24-week 2 × 2 factorial randomized controlled trial comparing insulin delivery and glucose monitoring modalities, with the goal of rigorous biochemical hypoglycemia avoidance. The analysis included 71 participants who had experienced severe hypoglycemia in the 12-month prestudy with confirmed absence (complete responder) or presence (incomplete responder) of severe hypoglycemia over 24 months' follow-up.
Results: There were 43 (61%) complete responders and 28 (39%) incomplete responders experiencing mean ± SD 1.5 ± 1.0 severe hypoglycemia events/person-year. At 24 months, incomplete responders spent no more time with glucose ≤3 mmol/L (1.4 ± 2.1% vs. 3.0 ± 4.8% for complete responders; = 0.26), with lower total daily insulin dose (0.45 vs. 0.58 units/24 h; = 0.01) and greater impairment of hypoglycemia awareness (Clarke score: 3.8 ± 2.2 vs. 2.0 ± 1.9; = 0.01). Baseline severe hypoglycemia rate (16.9 ± 16.3 vs. 6.4 ± 10.8 events/person-year; = 0.002) and fear of hypoglycemia were higher in incomplete responders. Peripheral neuropathy was more prevalent in incomplete responders (11 [39%] vs. 2 [4.7%]; < 0.001) with a trend toward increased autonomic neuropathy.
Conclusions: Recurrent severe hypoglycemia was associated with higher preintervention severe hypoglycemia rate, fear of hypoglycemia, and concomitant neuropathy.
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| http://dx.doi.org/10.2337/dc19-0630 | DOI Listing |
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