Journal of diabetes science and technology · 2023
The Effect of Do-It-Yourself Real-Time Continuous Glucose Monitoring on Glycemic Variables and Participant-Reported Outcomes in Adults With Type 1 Diabetes: A Randomized Crossover Trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Sehgal Shekhar, Elbalshy Mona, Williman Jonathan, Galland Barbara, Crocket Hamish, Hall Rosemary, Paul Ryan, Leikis Robert, de Bock Martin, Wheeler Benjamin J
Аннотация
AIM: Real-time continuous glucose monitoring (rtCGM) has several advantages over intermittently scanned continuous glucose monitoring (isCGM) but generally comes at a higher cost. Do-it-yourself rtCGM (DIY-rtCGM) potentially has benefits similar to those of rtCGM. This study compared outcomes in adults with type 1 diabetes using DIY-rtCGM versus isCGM.
METHODS: In this crossover trial, adults with type 1 diabetes were randomized to use isCGM or DIY-rtCGM for eight weeks before crossover to use the other device for eight weeks, after a four-week washout period where participants reverted back to isCGM. The primary endpoint was time in range (TIR; 3.9-10 mmol/L). Secondary endpoints included other glycemic control measures, psychosocial outcomes, and sleep quality.
RESULTS: Sixty participants were recruited, and 52 (87%) completed follow-up. Glucose outcomes were similar in the DIY-rtCGM and isCGM groups, including TIR (53.1% vs 51.3%; mean difference -1.7% P = .593), glycosylated hemoglobin (57.0 ± 17.8 vs 61.4 ± 12.2 mmol/L; P = .593), and time in hypoglycemia <3.9 mmol/L (3.9 ± 3.8% vs 3.8 ± 4.0%; P = .947). Hypoglycemia Fear Survey total score (1.17 ± 0.52 vs 0.97 ± 0.54; P = .02) and fear of hypoglycemia score (1.18 ± 0.64 vs 0.97 ± 0.45; P = .02) were significantly higher during DIY-rtCGM versus isCGM. Diabetes Treatment Satisfaction Questionnaire status (DTSQS) score was also higher with DIY-rtCGM versus isCGM (28.7 ± 5.8 vs 26.0 ± 5.8; P = .04), whereas diabetes-related quality of life was slightly lower (DAWN2 Impact of Diabetes score: 3.11 ± 0.4 vs 3.32 ± 0.51; P = .045); sleep quality did not differ between the two groups.
CONCLUSION: Although the use of DIY-rtCGM did not improve glycemic outcomes compared with isCGM, it positively impacted several patient-reported psychosocial variables. DIY-rtCGM potentially provides an alternative, cost-effective rtCGM option.
METHODS: In this crossover trial, adults with type 1 diabetes were randomized to use isCGM or DIY-rtCGM for eight weeks before crossover to use the other device for eight weeks, after a four-week washout period where participants reverted back to isCGM. The primary endpoint was time in range (TIR; 3.9-10 mmol/L). Secondary endpoints included other glycemic control measures, psychosocial outcomes, and sleep quality.
RESULTS: Sixty participants were recruited, and 52 (87%) completed follow-up. Glucose outcomes were similar in the DIY-rtCGM and isCGM groups, including TIR (53.1% vs 51.3%; mean difference -1.7% P = .593), glycosylated hemoglobin (57.0 ± 17.8 vs 61.4 ± 12.2 mmol/L; P = .593), and time in hypoglycemia <3.9 mmol/L (3.9 ± 3.8% vs 3.8 ± 4.0%; P = .947). Hypoglycemia Fear Survey total score (1.17 ± 0.52 vs 0.97 ± 0.54; P = .02) and fear of hypoglycemia score (1.18 ± 0.64 vs 0.97 ± 0.45; P = .02) were significantly higher during DIY-rtCGM versus isCGM. Diabetes Treatment Satisfaction Questionnaire status (DTSQS) score was also higher with DIY-rtCGM versus isCGM (28.7 ± 5.8 vs 26.0 ± 5.8; P = .04), whereas diabetes-related quality of life was slightly lower (DAWN2 Impact of Diabetes score: 3.11 ± 0.4 vs 3.32 ± 0.51; P = .045); sleep quality did not differ between the two groups.
CONCLUSION: Although the use of DIY-rtCGM did not improve glycemic outcomes compared with isCGM, it positively impacted several patient-reported psychosocial variables. DIY-rtCGM potentially provides an alternative, cost-effective rtCGM option.