Predictors of Recurrent Severe Hypoglycemia in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia During the HypoCOMPaSS Study

Abstract

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 3 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 6 SD 1.5 6 1.0 severe hypoglycemia events/person-year. At 24 months, incomplete responders spent no more time with glucose £3 mmol/L (1.4 6 2.1% vs. 3.0 6 4.8% for complete responders; P 5 0.26), with lower total daily insulin dose (0.45 vs. 0.58 units/24 h; P 5 0.01) and greater impairment of hypoglycemia awareness (Clarke score: 3.8 6 2.2 vs. 2.0 6 1.9; P 5 0.01). Baseline severe hypoglycemia rate (16.9 6 16.3 vs. 6.4 6 10.8 events/person-year; P 5 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%]; P < 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.

Prevalence of bone fracture and its association with severe hypoglycemia in Japanese patients with type 1 diabetes

“…43 It may at least explain the failure of some previous studies to show an association between hypoglycemia and fracture risk. Because severe hypoglycemia is strongly associated with impaired awareness of hypoglycemia, 44 we were able to assess the relationship between hypoglycemia and fracture risk more accurately in the present study than in these previous studies. Indeed, 40% of the participants with a history of any type of fracture after the diagnosis of T1D reported that they had experienced impaired awareness of hypoglycemia (data not shown).…”

β‐Cell and renal transplantation options for diabetes

“…It appears that there may be another subgroup with irreversible impaired awareness of hypoglycaemia and ongoing severe hypoglycaemia despite multimodality optimized conventional therapy. In the HypoCOMPaSS trial, continued episodes of severe hypoglycaemia were associated with established neuropathy . Identification of those at highest risk allows early referral for a discussion with the transplant team, even though further exploration of medical options may be advocated initially.…”

Relationship Between Pre-operative Blood Glucose Level and Length of Hospital Stay in Patients With Renal Cell Carcinoma Undergoing Laparoscopic Nephrectomy

“…A growing number of studies have found that pre-operative blood glucose (POBG) has adverse effects on patients undergoing surgery. A retrospective study of 4,025 patients who underwent appendectomy and 4,266 patients who underwent laparoscopic cholecystectomy found that higher POBG levels were significantly correlated with longer length of stay (LOS) ( 10 ). In addition, one study found that non-diabetic patients with higher POBG had a higher 1-year mortality rate than diabetic patients with similar blood glucose levels when underwent elective non-cardiac surgery ( 11 ).…”