Evaluation of FreeStyle Libre Flash Glucose Monitoring System on Glycemic Control, Health-Related Quality of Life, and Fear of Hypoglycemia in Patients with Type 1 Diabetes

Abstract

Background/objectives:In the current era of modern technology and the development of smart devices such as the flash glucose monitoring (FGM) systems, patients can easily monitor their glucose levels more frequently without any inconvenience. In this study, we evaluate the effect of FreeStyle Libre FGM system on glycemic control, hypoglycemia, health-related quality of life (QoL), and the fear of hypoglycemia (FOH) among children and young people with type 1 diabetes (T1D).Design and methods:A prospective study was conducted at the Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia, between January 2017 and May 2017 on 47 (aged 13-19 years) registered patients with T1D who used conventional finger-pricking method for self-testing the glucose. At baseline visit, the FGM sensors were placed on each participant by a trained diabetes educator. The data collected from the sensors were computed to generate the respective ambulatory glucose profiles so as to determine the total number of scans conducted during the study period. At the baseline and at 3 months of the experiment, a trained interviewer administered the questionnaire Hypoglycemia Fear Survey-Child Version (HFS-C) and PedsQL 3.0 (QoL questionnaire) to each patient. The age, sex, weight, height, adjusted body mass index, duration of diabetes, treatment modality, and glycosylated hemoglobin A1c (HbA1c) levels of each patient were recorded.Results:As compared with the baseline, a significant improvement was noted in the behavior of FOH (P = .0001), worry (P = .0001), QoL (P = .002), HbA1c level (P = .008), and hypoglycemia (P = .023) at 3 months. Significant improvement was noted in the behavior (P = .0001), worry (P = .0001), QoL (P = .003), HbA1c level (P = .014), and hypoglycemia (P = .001) among the multiple-dose insulin injection–treated patients as compared with baseline. Significant improvement was noted in the behavior (P = .0001), worry (P = .0001), and hypoglycemia (P = .001) among the insulin pump–treated patients as compared with baseline. A positive correlation was recorded in the behavior (r = .47; P < .001), QoL (r = .70; P < .001), and the mean number of FGM scans. A negative correlation was recorded in the worry (r = −.43; P = .002), HbA1c level (r = −.58; P < .001), hypoglycemia (r = −.65; P < .001), and the mean number of FGM scans.Conclusions:The frequent use of FGM scanning reduced the frequency of hypoglycemia, HbA1c level, and worry and increased the behavior and QoL. As compared with self-testing by the conventional finger-pricking method, the use of FGM increased the frequency of self-testing and thus diabetes control.

Non-adjunctive flash glucose monitoring system use during summer-camp in children with type 1 diabetes: The free-summer study

“…In addition to previous reports, this is to our knowledge the first randomized controlled trial to evaluate the non‐adjunctive use of isCGM in the pediatric population with T1D. Two previous randomized controlled trials in adult patients with diabetes demonstrated safety and efficacy of isCGM to replace SMBG .…”

“…The sensor‐based flash glucose monitoring system (FreeStyle Libre, Abbott Diabetes Care), an isCGM device can be scanned as often as needed with the reader displaying current sensor glucose level, glucose trend arrow and graphs of the glucose readings over the previous 8 hours; furthermore, it does not require finger‐stick calibration, as it is calibrated in the factory, and has a wear period of 14 days (10 days and a 12‐hour warm‐up period in the United States) . Recently published data have demonstrated safety and efficacy of isCGM technology to replace SMBG in adult patients with diabetes and good accuracy results in pediatric and adolescent population with T1D, with little data on benefit in glycemic control in this population . The aim of the present study was to evaluate efficiency and safety of isCGM as a replacement for standard SMBG‐based glucose control in children with type 1 diabetes (T1D) during a summer camp.…”

“…23,24 Recently published data have demonstrated safety and efficacy of isCGM technology to replace SMBG in adult patients with diabetes 25 and good accuracy results in pediatric and adolescent population with T1D, with little data on benefit in glycemic control in this population. [26][27][28][29] The aim of the present study was to evaluate efficiency and safety of isCGM as a replacement for standard SMBG-based glucose control in children with type 1 diabetes (T1D) during a summer camp. The inclusion criteria were: age 6 to 15 years (both inclusive), clinical diagnosis of T1D for at least 6 months prior to study enrolment, at least 3 months of current use of an insulin pump, HbA1c between 6.3% (45 mmol/mol) and 10% (86 mmol/mol), self-reported regular SMBG, body mass index (BMI) within normal range for age and sex (5th-95th centile) and the absence of other medical conditions (apart from well-controlled hypothyroidism or coeliac disease).…”

Accuracy of flash glucose monitoring in insulin‐treated patients with type 2 diabetes

“…What is noteworthy about this system is that self-monitoring of blood glucose is not required during the 14-day wearing period. Several studies have shown the accuracy of interstitial glucose measurements, and the usefulness and safety of FGM [5][6][7][8][9][10][11] . Furthermore, it has been shown that the use of FGM reduced hypoglycemia in patients with type 1 and type 2 diabetes mellitus, although the effects of FGM on glycemic control are controversial 7,8,[12][13][14][15] .…”

“…Several studies have shown the accuracy of interstitial glucose measurements, and the usefulness and safety of FGM [5][6][7][8][9][10][11] . Furthermore, it has been shown that the use of FGM reduced hypoglycemia in patients with type 1 and type 2 diabetes mellitus, although the effects of FGM on glycemic control are controversial 7,8,[12][13][14][15] . However, in most of the earlier studies, capillary blood glucose, not venous blood glucose, was used as a reference, and the accuracy of glucose measurements by FGM has not been fully determined 5,6,9,10,16 .…”