Comparison of flash glucose monitoring with real time continuous glucose monitoring in children and adolescents with type 1 diabetes treated with continuous subcutaneous insulin infusion

      Abstract

      Aims

      In 2016 intermittently scanned continuous glucose monitoring (isCGM) became the first reimbursed CGM system in Belgium. Many children with type 1 diabetes (T1D) treated with multiple daily injections as well as with continuous subcutaneous insulin infusion (CSII) switched from self-monitoring of blood glucose to isCGM to monitor their treatment. In 2017 the Enlite® real-time CGM (rtCGM) system was reimbursed enabling its use with the Minimed® 640G insulin pump with integrated SmartGuard technology. In this study we compared the metabolic control during CSII with isCGM with that during rtCGM. Patient’s satisfaction and side effects of the rtCGM system were also evaluated.

      Methods

      20 children with T1D, aged 5–16 years, were included. Metabolic control during the last month of isCGM use was compared to that during the 3rd and 6th month of rtCGM.

      Results

      Three patients stopped early rtCGM mainly due to calibration burden. The HbA1c level and the mean glucose value in the other patients did not change after switching to the rtCGM system. Glucose variability was smaller (46.2% vs 38.4% and 36.4%, p = 0.000). Time in hypoglycemia (<70 mg/dl) was lower (7.4% vs 1.6% and 1.5%, p = 0.000). The main patient inconvenience was the sensor calibration.

      Conclusions

      Our data show that during Enlite® rtCGM with the Minimed® 640G pump system glucose variability was smaller and the patients spent less time in hypoglycemia than during isCGM. The need for timely calibrations is considered as the main drawback of the system.

      Keywords

      To read this article in full you will need to make a payment

      References

        • Rawshani A.
        • Sattar N.
        • Franzén S.
        • et al.
        Excess mortality and cardiovascular disease in young adults with type 1 diabetes in relation to age at onset: a nationwide, register-based cohort study.
        Lancet. 2018; 392: 477-486
        • Donaghue K.C.
        • Marcovecchio M.L.
        • Wadwa R.P.
        • et al.
        ISPAD Clinical Practice Consensus Guidelines 2018: Microvascular an macrovascular complications in children and adolescents.
        Pediatr Diabetes. 2018; 19: 262-274
        • Danne T.
        • Nimri R.
        • Battelino T.
        • et al.
        International consensus on use of continuous glucose monitoring.
        Diabetes Care. 2017; 40: 1631-1640
        • Sherr J.
        • Tauschmann M.
        • Battelino T.
        • et al.
        ISPAD clinical practice consensus guidelines 2018: diabetes technologies.
        Pediatr Diabetes. 2018; 19: 302-325
        • Szypowska A.
        • Ramotowska A.
        • Dzygalo K.
        • Golicki D.
        Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials.
        Eur J Endocrinol. 2012; 166: 567-574
        • Charleer S.
        • Mathieu Ch.
        • Nobels F.
        • et al.
        Effect of continuous glucose monitoring on glycemic control, acute admissions, and quality of life: a real-world study.
        J Clin Endocrinol Metab. 2018; 103: 1224-1232
        • Veeze H.
        • Rasmussen L.G.
        • Agrawal P.
        • et al.
        Real-life performance evaluation of the New Generation Enlite™ glucose sensor in patients with diabetes mellitus.
        Pediatr Diabetes. 2014; (15(S19):100(P136))
        • Cohen O.
        • Andersen G.
        • Huang S.
        • et al.
        Accuracy of the continuous glucose sensor used with the predictive low glucose management system.
        Diabetes Technol Ther. 2016; (18(S1):A81 (Abstract 204))
        • Danne T.
        • Tsioli Ch.
        • Kordonouri O.
        • et al.
        The PILGRIM study: in silico modeling of a predictive low glucose management system and feasibility in youth with type 1 diabetes during exercise.
        Diabetes Technol Ther. 2014; 16: 338-347
        • Choudhary P.
        • Olsen B.S.
        • Conget I.
        • Welsh J.B.
        • Vorrink L.
        • Shin J.J.
        Hypoglycemia prevention and user acceptance of an insulin pump system with predictive low glucose management.
        Diabetes Technol Ther. 2016; 18: 288-291
        • Zhong A.
        • Choudhary P.
        • McMahon Ch.
        • et al.
        Effectiveness of automated insulin management features of the Minimed® 640G sensor-augmented insulin pump.
        Diabetes Technol Ther. 2016; 18: 657-663
        • Biester T.
        • Kordonouri O.
        • Holder M.
        • et al.
        “Let the algorithm do the work”: reduction of hypglycemia using sensor-augmented pump therapy with predictive insulin suspension (Smartguard) in pediatric type 1 diabetes patients.
        Diabetes Technol Ther. 2017; 19: 173-182
        • Battelino T.
        • Nimri R.
        • Dovc K.
        • Philip M.
        • Bratina N.
        Prevention of hypoglycemia with predictive low glucose insulin suspension in children with type 1 diabetes: a randomized controlled trial.
        Diabetes Care. 2017; 40: 764-770
        • Villafuerte Quispe B.
        • Martin Frias M.
        • Roldán Martín M.B.
        • Yelmo Valverde R.
        • Álvarez Gómez M.Á.
        • Barrio Castellanos R.
        Effectiveness of MiniMed 640G with SmartGuard® System for prevention of hypoglycemia in pediatric patients with type 1 diabetes mellitus.
        Endocrinol Diabetes Nutr. 2017; 64: 198-203
        • Wong J.C.
        • Foster N.C.
        • Maahs D.M.
        • et al.
        Real-time continuous glucose monitoring among participants in the T1D exchange clinic registry.
        Diabetes Care. 2014; 37: 2702-2709
        • Taddeo R.L.
        • Moser J.R.
        • Minnock P.P.
        Continuous glucose monitoring in pediatrics: the gap between potential benefits and the reality of utility.
        Pediatr Endocrinol Rev. 2017; 14: 435-440
        • Bailey T.
        • Bode B.W.
        • Christiansen M.P.
        • Klaff L.J.
        • Alva S.
        The performance and usability of a factory-calibrated flash glucose monitoring system.
        Diabetes Technol Ther. 2015; 17: 787-794
        • Leelarathna L.
        • Wilmot E.G.
        Flash forward: a review of flash glucose monitoring.
        Diabet Med. 2018; 35: 472-482
        • Hoss U.
        • Budiman E.S.
        Factory-calibrated continuous glucose sensors: the science behind the technology.
        Diabetes Technol Ther. 2017; 19: S44-S50
        • Heinemann L.
        • Freckmann G.
        CGM versus FGM; or, continuous glucose monitoring is not flash glucose monitoring.
        J Diabetes Sci Technol. 2015; 9: 947-950
        • Massa G.G.
        • Gys I.
        • Op’t Eyndt A.
        • et al.
        Evaluation of the FreeStyle® libre flash glucose monitoring system in children and adolescents with type 1 diabetes.
        Horm Research Pediatr. 2018; 89: 189-199
        • Charleer S.
        • Mathieu C.
        • Nobels F.
        • Gillard P.
        Accuracy and precision of flash glucose monitoring sensors inserted into the abdomen and upper thigh compared with the upper arm.
        Diabetes Obes Metab. 2018; 20: 1503-1507
        • Christiansen M.P.
        • Garg S.K.
        • Brazg R.
        • et al.
        Accuracy of a fourth-generation subcutaneous continuous glucose sensor.
        Diabetes Technol Ther. 2017; 19: 446-456
        • Edge J.
        • Acerini C.
        • Campbell F.
        • et al.
        An alternative sensor-based method for glucose monitoring in children and young people with diabetes.
        Arch Dis Child. 2017; 102: 543-549
        • Kovatchev B.P.
        • Cox D.J.
        • Gonder-Frederick L.A.
        • Young-Hyman D.
        • Schlundt D.
        • Clarke W.
        Assessment of risk for severe hypoglycemia among adults with IDDM.
        Diabetes Care. 1998; 21: 1870-1875
        • Beck R.W.
        • Connor C.G.
        • Mullen D.M.
        • Wesley D.M.
        • Bergenstal R.M.
        The fallacy of average: how using HbA1c alone to assess glycemic control can be misleading.
        Diabetes Care. 2017; 40: 994-999
        • Szadkowska A.
        • Gawrecki A.
        • Michalak A.
        • Zozulinska-Ziólkiewicz D.
        • Fendler W.
        • Mlynarski W.
        Flash glucose measurements in children with type 1 diabetes in real-life settings: to trust or not to trust?.
        Diabetes Technol Ther. 2018; 20: 17-24
        • Piona C.
        • Dovc K.
        • Mutlu G.Y.
        • et al.
        Non-adjunctive flash glucose monitoring system use during summer-camp in children with type 1 diabetes: The free-summer study.
        Pediatr Diabetes. 2018; 19: 1285-1293
        • Wijnands A.
        • Gys I.
        • Bevilacqua E.
        • et al.
        The freestyle flash glucose monitoring system has limited effect on the metabolic control of children and adolescents with type 1 diabetes mellitus.
        Pediatr Diabetes. 2017; 17 (Abstract O46): 38
        • Herman A.
        • Aerts O.
        • Baeck M.
        • et al.
        Allergic contact dermatitis caused by isobornyl acrylate in FreeStyle® Libre, a newly introduced glucose sensor.
        Contact Dermatitis. 2017; 77: 426-429
        • Bailey T.S.
        • Ahmann A.
        • Brazg R.
        • et al.
        Accuracy and acceptability of the 6-day enlite continuous subcutaneous glucose sensor.
        Diabetes Technol Therap. 2014; 16: 277-283
        • Monnier L.
        • Colette C.
        • Wojtusciszyn A.
        • et al.
        Toward defining the threshold between low and high glucose variability in diabetes.
        Diabetes Care. 2017; 40: 832-838
        • Marchand L.
        • Reffet S.
        • Vouillarmet J.
        • Cugnet-Anceau C.
        • Disse E.
        • Thivolet C.
        The 36% coefficient of variation for glucose proposed for separating stable and labile diabetes is clinically relevant: A continuous glucose monitoring-based study in a large population of type 1 diabetes patients.
        Diabetes Metab. 2018; https://doi.org/10.1016/j.diabet.2018.05.009
        • Ceriello A.
        • Esposito K.
        • Piconi L.
        • et al.
        Oscillating glucose is more deleterious to endothelial function and oxidative stress than mean glucose in normal and type 2 diabetic patients.
        Diabetes. 2008; 57: 1349-1354
        • Soupal J.
        • Skrha J.
        • Fajmon M.
        • et al.
        Glycemic variability is higher in type 1 diabetes patients with microvascular complications irrespective of glycemic control.
        Diabetes Technol Ther. 2014; 16: 198-203
        • Skrha J.
        • Soupal J.
        • Skrha Jr, J.
        • Prázný
        Glucose variability, HbA1c and microvascular complications.
        Rev Endocr Metab Disord. 2016; 1: 103-110
        • Ceriello A.
        Glycemic variability, persistent oxidative stress, and diabetic complications.
        Medicographa. 2017; 39: 233-236
        • Abraham M.A.
        • Jones T.W.
        • Naranjo D.
        • et al.
        ISPAD Clinical Practice Consensus Guidelines 2018: Assessment and management of hypoglycemia in children and adolescents with diabetes.
        Ped Diabetes. 2018; 19: 178-192
        • Viaene A.S.
        • Van Daele T.
        • Bleys D.
        • Faust K.
        • Massa G.G.
        Fear of hypoglycemia, parenting stress, and metabolic control for children with type 1 diabetes and their parents.
        J Clin Psychol Med Settings. 2017; 24: 74-81
        • Jaiswal M.
        • McKoen K.
        • Comment N.
        • et al.
        Association between impaired cardiovascular autonomic function and hypoglycemia in patients with type 1 diabetes.
        Diabetes Care. 2014; 37: 2616-2621
        • Evans K.
        • Richardson Ch.
        • Landry A.
        • Muileboom J.
        • Cornmack L.
        • Lawson M.L.
        • on behalf of the CGM TIME Trial Study Group and the JDRF Canadian Clinical Trials Network CCTN1101
        Experience with the Enlite sensor in a multicenter pediatric study.
        Diabetes Educ. 2015; 41: 31-37
        • Heinemann L.
        • Kamann S.
        Adhesives used for diabetes medical devices. A neglected risk with serious consequences?.
        J Diabetes Sci Technol. 2016; 10: 1211-1215
        • Kamann S.
        • Aerts O.
        • Heinemann L.
        Further evidence of severe allergic contact dermatitis from isobornyl acrylate while using a continuous glucose monitoring system.
        J Diabetes Sci Technol. 2018; 12: 630-633