Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, randomizované kontrolované studie, práce podpořená grantem
PubMed
32859607
PubMed Central
PMC7576432
DOI
10.2337/dc20-0112
PII: dc20-0112
Knihovny.cz E-zdroje
- MeSH
- cvičení fyziologie MeSH
- diabetes mellitus 1. typu krev farmakoterapie MeSH
- dospělí MeSH
- glykovaný hemoglobin analýza účinky léků metabolismus MeSH
- hypoglykemie krev chemicky indukované MeSH
- hypoglykemika terapeutické užití MeSH
- krevní glukóza analýza účinky léků metabolismus MeSH
- lidé středního věku MeSH
- lidé MeSH
- počítače do ruky MeSH
- počítačové systémy MeSH
- regulace glykemie přístrojové vybavení metody MeSH
- selfmonitoring glykemie metody MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- glykovaný hemoglobin MeSH
- hypoglykemika MeSH
- krevní glukóza MeSH
OBJECTIVE: The aim of this trial was to compare the efficacy of real-time and intermittently scanned continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control. RESEARCH DESIGN AND METHODS: In this randomized study, adults with type 1 diabetes (T1D) and normal hypoglycemia awareness (Gold score <4) used rtCGM (Guardian Connect Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) and in the subsequent 4 weeks at home (home phase). Primary end points were time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) and time in range (3.9-10.0 mmol/L [70-180 mg/dL]). The isCGM group wore an additional masked Enlite sensor (iPro2) for 6 days to check for bias between the different sensors used by the rtCGM and isCGM systems. RESULTS: Sixty adults with T1D (mean age 38 ± 13 years; A1C 62 ± 12 mmol/mol [7.8 ± 1.1%]) were randomized to rtCGM (n = 30) or isCGM (n = 30). All participants completed the study. Percentage of time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) was lower among rtCGM versus isCGM participants in the exercise phase (6.8 ± 5.5% vs. 11.4 ± 8.6%, respectively; P = 0.018) and during the home phase (5.3 ± 2.5% vs. 7.3 ± 4.4%, respectively; P = 0.035). Hypoglycemia differences were significant and most notable during the night. rtCGM participants spent more time in range (3.9-10 mmol/L [70-180 mg/dL]) than isCGM participants throughout both the exercise (78.5 ± 10.2% vs. 69.7 ± 16%, respectively; P = 0.0149) and home (75.6 ± 9.7% vs. 67.4 ± 17.8%, respectively; P = 0.0339) phases. The results were robust to the insignificant bias between rtCGM and isCGM sensors that masked CGM found in the isCGM arm. CONCLUSIONS: rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.
3rd Department of Internal Medicine 1st Faculty of Medicine Charles University Prague Czech Republic
CGParkin Communications Inc Henderson NV
Department of Paediatrics 2nd Faculty of Medicine Charles University Prague Czech Republic
Zobrazit více v PubMed
Cryer PE. Hypoglycemia: still the limiting factor in the glycemic management of diabetes. Endocr Pract 2008;14:750–756 PubMed
Zinman B, Murray FT, Vranic M, et al. . Glucoregulation during moderate exercise in insulin treated diabetics. J Clin Endocrinol Metab 1977;45:641–652 PubMed
Moser O, Tschakert G, Mueller A, et al. . Effects of high-intensity interval exercise versus moderate continuous exercise on glucose homeostasis and hormone response in patients with type 1 diabetes mellitus using novel ultra-long-acting insulin. PLoS One 2015;10:e0136489. PubMed PMC
Younk LM, Mikeladze M, Tate D, Davis SN. Exercise-related hypoglycemia in diabetes mellitus. Expert Rev Endocrinol Metab 2011;6:93–108 PubMed PMC
Beck RW, Riddlesworth T, Ruedy K, et al. .; DIAMOND Study Group . Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: the DIAMOND randomized clinical trial. JAMA 2017;317:371–378 PubMed
Heinemann L, Guido Freckmann G, Gabriele Faber-Heinemann G, et al. . Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial. Lancet 2018;391:1367–1377 PubMed
Šoupal J, Petruželková L, Flekač M, et al. . Comparison of different treatment modalities for type 1 diabetes, including sensor-augmented insulin regimens, in 52 weeks of follow-up: a COMISAIR study. Diabetes Technol Ther 2016;18:532–538 PubMed PMC
Šoupal J, Petruželková L, Grunberger G, et al. . Glycemic outcomes in adults with T1D are impacted more by continuous glucose monitoring than by insulin delivery method: 3 years of follow-up from the COMISAIR Study. Diabetes Care 2020;43:37–43 PubMed
Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet 2016;388:2254–2263 PubMed
Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia 2018;61:539–550 PubMed PMC
Reddy M, Jugnee N, El Laboudi A, Spanudakis E, Anantharaja S, Oliver N. A randomized controlled pilot study of continuous glucose monitoring and flash glucose monitoring in people with type 1 diabetes and impaired awareness of hypoglycaemia. Diabet Med 2018;35:483–490 PubMed PMC
Reddy M, Jugnee N, Anantharaja S, Oliver N. Switching from flash glucose monitoring to continuous glucose monitoring on hypoglycemia in adults with type 1 diabetes at high hypoglycemia risk: the extension phase of the I HART CGM study. Diabetes Technol Ther 2018;20:751–757 PubMed PMC
World Medical Association Declaration of Helsinki Recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997;277:925–926 PubMed
Gold AE, MacLeod KM, Frier BM. Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia. Diabetes Care 1994;17:697–703 PubMed
The WHOQOL Group Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychol Med 1998;28:551–558 PubMed
Lind M, Polonsky W, Hirsch IB, et al. . Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: the GOLD randomized clinical trial. JAMA 2017;317:379–387 PubMed
Danne T, Nimri R, Battelino T, et al. . International consensus on use of continuous glucose monitoring. Diabetes Care 2017;40:1631–1640 PubMed PMC
Battelino T, Danne T, Bergenstal RM, et al. . Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care 2019;42:1593–1603 PubMed PMC
Lamounier RN, Geloneze B, Leite SO, et al. .; HAT Brazil study group . Hypoglycemia incidence and awareness among insulin-treated patients with diabetes: the HAT study in Brazil. Diabetol Metab Syndr 2018;10:83. PubMed PMC
Polonsky WH, Hessler D, Ruedy KJ, Beck RW; DIAMOND Study Group . The impact of continuous glucose monitoring on markers of quality of life in adults with type 1 diabetes: further findings from the DIAMOND randomized clinical trial. Diabetes Care 2017;40:736–741 PubMed