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Self-reported Severe and Nonsevere Hypoglycemia in Type 1 Diabetes: Population Surveillance Through the BETTER Patient Engagement Registry: Development and Baseline Characteristics

      Abstract

      Objectives

      The BETTER (BEhaviors, Therapies, TEchnologies and hypoglycemic Risk in Type 1 diabetes) registry is a type 1 diabetes population surveillance system codeveloped with patient-partners to address the burden of hypoglycemia and assess the impact of new therapies and technologies. The aim of this report was to describe the baseline characteristics of the BETTER registry cohort.

      Methods

      A cross-sectional baseline evaluation was performed of a Canadian clinical cohort established after distribution of an online questionnaire. Participants were recruited through clinics, public foundations, advertising and social media. As of February 2021, 1,430 persons ≥14 years of age and living with type 1 diabetes or latent-autoimmune diabetes (LADA) were enrolled. The trial was registered on ClinicalTrials.gov (NCT03720197).

      Results

      Participants were (mean ± standard deviation) 41.2±15.7 years old with a diabetes duration of 22.0±14.7 years, 62.0% female, 92.1% Caucasian and 7.8% self-reporting as LADA, with 40.9% using a continuous subcutaneous insulin infusion system (CSII) and 78.0% using a continuous glucose monitoring system (CGM). The most recent glycated hemoglobin ≤7% was reported by 29.7% of participants. At least 1 episode of hypoglycemia <3.0 mmol/L (level 2-H) in the last month was reported by 78.4% of participants, with a median (interquartile range) of 5 (3, 10) episodes. The occurrence of severe hypoglycemia (level 3-H) in the last 12 months was reported by 13.3% of participants. Among these, the median number of episodes was 2 (1, 3).

      Conclusions

      We have established the first surveillance registry for people living with type 1 diabetes in Canada relying on patient-reported outcomes and experiences. Hypoglycemia is a highly prevalent burden despite a relatively wide adoption of CSII and CGM use.

      Résumé

      Objectifs

      Le registre BETTER (BEhaviors, Therapies, TEchnologies and hypoglycemic Risk in Type 1 diabetes) est un système de surveillance de la population atteinte du diabète de type 1 conçu en collaboration avec des patients partenaires pour alléger le fardeau de l’hypoglycémie et évaluer les répercussions des nouveaux traitements et des nouvelles technologies. L’objectif du présent compte rendu était de décrire les caractéristiques initiales de la cohorte du registre BETTER.

      Méthodes

      Nous avons réalisé une évaluation transversale initiale d’une cohorte clinique canadienne établie après la distribution d’un questionnaire en ligne. Nous avons recruté les participants dans les cliniques, les fondations publiques, par la publicité et les médias sociaux. Dès février 2021 1430 personnes se sont inscrites, âgées de ≥ 14 ans et vivant avec le diabète de type 1 ou un diabète auto-immun latent (LADA, de l’anglais latent-autoimmune diabetes). L’essai a été enregistré au ClinicalTrials.gov (NCT03720197).

      Résultats

      Les participants avaient (moyenne ± écart type) 41,2 ± 15,7 ans et une durée de diabète de 22,0 ± 14,7 ans; 62,0 % étaient des femmes; 92,1 % étaient des Blancs ; 7,8 % déclaraient avoir un LADA; 40,9 % utilisaient un système de perfusion sous-cutanée continue d’insuline (PSCI); 78,0 % utilisaient un système de surveillance du glucose en continu (SGC). L’hémoglobine glyquée la plus récente ≤ 7 % était signalée par 29,7 % des participants. Parmi eux, 78,4 % signalaient au moins 1 épisode d’hypoglycémie < 3,0 mmol/L (H-degré 2) au cours du dernier mois (médiane [intervalle interquartile] de 5 épisodes [3 à 10]), et 13,3 % signalaient avoir subi une hypoglycémie grave (H-degré 3) au cours des 12 derniers mois (nombre médian d’épisodes de 2 [1 à 3]).

      Conclusions

      Nous avons établi le premier registre de surveillance des personnes diabétiques de type 1 au Canada qui repose sur les résultats et les expériences signalés par le patient. L’hypoglycémie est très répandue en dépit de l’adoption assez généralisée de la PSCI et de l’utilisation de la SGC.

      Mots clés

      Keywords

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