PUBLISHED CLINICAL AND ECONOMIC EVIDENCE AS A PREREQUISITE FOR ASSESSING THE VALUE OF CONTINUOUS GLUCOSE MONITORING SYSTEMS (CGM)
Author(s)
Ula Ona Kibildyte, BSc1, Tomasz Klupa, Prof.2, Johan Jendle, MD, PhD3, Jessica Yumi Matuoka, PhD, BSN, MSc4, Yves Haufe, PhD, MSc5.
1Dexcom, Vilnius, Lithuania, 2Jagiellonian University Medical College, Kraków, Poland, 3Örebro University, Örebro, Sweden, 4Dexcom, Inc, San Rafael, CA, USA, 5Dexcom, Madrid, Spain.
1Dexcom, Vilnius, Lithuania, 2Jagiellonian University Medical College, Kraków, Poland, 3Örebro University, Örebro, Sweden, 4Dexcom, Inc, San Rafael, CA, USA, 5Dexcom, Madrid, Spain.
OBJECTIVES: CGMs have revolutionized diabetes management, and the number of manufacturers has expanded significantly. CGMs with integrated CGM (iCGM) clearance are interoperable with other devices, including automated insulin delivery (AID) systems. Clinically demonstrated accuracy and precision of estimated glucose are essential prerequisites of CGM systems. In this study, evidence on two key value components - clinical effectiveness and cost-effectiveness (CEA) - was tabulated to assess the amount of publicly available support for CGM systems across manufacturers.
METHODS: Twenty-one CGM and/or AID manufacturers were included. Clinicaltrials.gov was queried to return registered, completed clinical studies where the intervention was CGM or iCGM. CEA studies published between 2004 and 2026 were queried through PubMed. Eligible studies investigated the cost-effectiveness of CGM or iCGM compared with capillary blood glucose or other CGM systems.
RESULTS: A total of 486 clinical studies were included (with 37.9% Dexcom, 22.2% Abbott, 19.1% MiniMed, 9.5% Tandem, 7.6%, Insulet, 3.7% other devices) and completed between 2006-2026. Ten manufacturers had no registered, completed clinical studies. Of 179 CGM-only studies, three manufacturers conducted 92.2% of the studies (42.5% Dexcom, 36.9% Abbott, 12.8% MiniMed). Four other companies conducted the remaining 14 studies (7.8%). Sixty-six CEA publications were included (68% CGM, 32% AID+CGM) that evaluated either Dexcom (40%) or Abbott (33%) devices, while 26% included more than one brand. About 71% of the AID+CGM publications evaluated a MiniMed AID system, while the remaining were either not stated, or included other device brands. Fifteen (71%) of the 21 manufacturers did not have CEAs published.
CONCLUSIONS: Three manufacturers generated nearly all the clinical and economic evidence available on CGMs. Without published studies, payers and health care professionals cannot determine the true value of a CGM system. Each manufacturer should publish sufficient evidence on the value of their CGM, as equivalence between brands cannot be assumed.
METHODS: Twenty-one CGM and/or AID manufacturers were included. Clinicaltrials.gov was queried to return registered, completed clinical studies where the intervention was CGM or iCGM. CEA studies published between 2004 and 2026 were queried through PubMed. Eligible studies investigated the cost-effectiveness of CGM or iCGM compared with capillary blood glucose or other CGM systems.
RESULTS: A total of 486 clinical studies were included (with 37.9% Dexcom, 22.2% Abbott, 19.1% MiniMed, 9.5% Tandem, 7.6%, Insulet, 3.7% other devices) and completed between 2006-2026. Ten manufacturers had no registered, completed clinical studies. Of 179 CGM-only studies, three manufacturers conducted 92.2% of the studies (42.5% Dexcom, 36.9% Abbott, 12.8% MiniMed). Four other companies conducted the remaining 14 studies (7.8%). Sixty-six CEA publications were included (68% CGM, 32% AID+CGM) that evaluated either Dexcom (40%) or Abbott (33%) devices, while 26% included more than one brand. About 71% of the AID+CGM publications evaluated a MiniMed AID system, while the remaining were either not stated, or included other device brands. Fifteen (71%) of the 21 manufacturers did not have CEAs published.
CONCLUSIONS: Three manufacturers generated nearly all the clinical and economic evidence available on CGMs. Without published studies, payers and health care professionals cannot determine the true value of a CGM system. Each manufacturer should publish sufficient evidence on the value of their CGM, as equivalence between brands cannot be assumed.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
SA90
Topic
Medical Technologies, Study Approaches
Topic Subcategory
Literature Review & Synthesis
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity), No Additional Disease & Conditions/Specialized Treatment Areas