Original Title: Avis: système de mesure du glucose en continu (Dexcom G6, Dexcom)

Authors' objectives: The Institut national d’excellence en santé et en services sociaux (INESSS) was mandated by the Bureau de l’innovation to assess the relevance of public coverage of the Dexcom G6® Mobile System, a continuous glucose monitoring (CGM) technology, for type 1 diabetics aged 2 years or older.

Authors' results and conclusions: RESULTS: The scientific evidence is based on seven publications from three RCTs: DIAMOND [Beck et al., 2017a], GOLD [Lind et al., 2017] and HypoDE [Heinemann et al., 2018]. Given the rapid technological developments in this area, with a life cycle of approximately 3 years, most of the clinical data for evaluating the G6 were obtained with previous generations of Dexcom (G4 and G5). The duration of the interventions was 6 months in all three RCTs. These studies compared the efficacy and safety of Dexcom monitors with capillary blood glucose monitoring in T1D patients receiving intensive insulin therapy (multiple insulin injections, MIIs). The pivotal study DIAMOND, which was funded by the manufacturer, involved 158 T1D patients 25 years of age and older with suboptimal glycemic control. The GOLD crossover RCT [Lind et al., 2017] involved 161 adult T1D patients with an HbA1c ≥ 7.5%. The total duration of this manufacturer-independent study was 69 weeks (2 x 26 weeks separated by a 17-week washout period). The HypoDE study [Heinemann et al., 2018], which was funded by the manufacturer, involved 149 T1D patients at high risk for severe hypoglycemia. The methodological limitations of these studies introduce a risk of bias that must be noted.

Authors' recommendations: The Institut national d'excellence en santé et en services sociaux recognizes the significant disease burden in patients with type 1 diabetes and the potential benefits of the Dexcom G6® System. The price proposed by the manufacturer does not make for an efficient option, and coverage would not be a fair, reasonable and equitable option. Consequently, INESSS recommends that the Dexcom G6® System not be covered under these conditions. SPECIFIC CONSIDERATIONS REGARDING IMPLEMENTATION: Pre-use training on the Dexcom G6® to enable patients to become proficient in applying the sensor and to learn how to interpret and use the information it transmits. Ongoing support from the diabetes team.

Authors' methods: A systematic literature review was conducted to identify the evidence relevant to the evaluation and to supplement the information submitted by the manufacturer. An advisory committee consisting of clinicians and patients was formed to gather experiential and contextual data to shed light on the potential benefits, the drawbacks, and the concerns associated with the use of the G6. Cost-effectiveness was evaluated using a model developed at INESSS and inspired by that developed by Health Quality Ontario (HQO). A budget impact analysis was also performed. All of the data gathered and generated by the project team were submitted to the Comité scientifique de l’évaluation des médicaments aux fins d’inscription (CSEMI) for the purpose of developing recommendations.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/systeme-de-mesure-du-glucose-en-continu-dexcom-g6mc-dexcom.html

Year Published: 2020

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/systeme-de-mesure-du-glucose-en-continu-dexcom-g6mc-dexcom.html

Requestor: Bureau de l’innovation

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec