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

Lookup NU author(s): Dr Anneliese Flatt, Dr Stuart Little, Dr Thomas Chadwick, Ruth Wood, Professor James Shaw

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This is the authors' accepted manuscript of an article that has been published in its final definitive form by American Diabetes Association, 2019.

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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; P = 0.26), with lower total daily insulin dose (0.45 vs. 0.58 units/24 h; P = 0.01) and greater impairment of hypoglycemia awareness (Clarke score: 3.8 ± 2.2 vs. 2.0 ± 1.9; P = 0.01). Baseline severe hypoglycemia rate (16.9 ± 16.3 vs. 6.4 ± 10.8 events/person-year; P = 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.


Publication metadata

Author(s): Flatt AJS, Little SA, Speight J, Leelarathna L, Walkinshaw E, Tan HK, Bowes A, Lubina-Solomon A, Holmes-Truscott E, Chadwick TJ, Wood R, McDonald TJ, Kerr D, Flanagan D, Brooks A, Heller SR, Evans ML, Shaw JAM

Publication type: Article

Publication status: Published

Journal: Diabetes Care

Year: 2019

Volume: 42

Issue: 10

Pages: 1-9

Print publication date: 01/10/2019

Online publication date: 04/09/2019

Acceptance date: 06/08/2019

Date deposited: 15/10/2019

ISSN (print): 0149-5992

ISSN (electronic): 1935-5548

Publisher: American Diabetes Association

URL: https://doi.org/10.2337/dc19-0630

DOI: 10.2337/dc19-0630

PubMed id: 31484666


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