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

血糖性 医学 交叉研究 低血糖 2型糖尿病 糖尿病 随机对照试验 1型糖尿病 连续血糖监测 内科学 血糖自我监测 临床终点 安慰剂 内分泌学 病理 替代医学
作者
Shekhar Sehgal,Mona Elbalshy,Jonathan Williman,Barbara C. Galland,Hamish Crocket,Rosemary M. Hall,Ryan Paul,Robert Leikis,Martin de Bock,Benjamin J. Wheeler
出处
期刊:Journal of diabetes science and technology [SAGE Publishing]
卷期号:19 (2): 415-425 被引量:2
标识
DOI:10.1177/19322968231196562
摘要

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.
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