Self-monitoring of blood glucose (SMBG) is the standard of care for diabetic patients treated with multiple daily insulin injections.1 Continuous glucose monitoring systems (CGMs) have the advantages of more complete information that may better guide clinical decision making and alert patients of hypoglycemic events.2 However, CGMs are expensive, are invasive, and need considerable time and skills for use and effective interpretation.2,3 Freestyle Libre (Abbott Diabetes Care Ltd, Range Road Witney, Oxon OX29 OYL; UK) is a novel factory-calibrated glucose monitoring system that is applied to the upper arm every 2 weeks. This flash glucose monitoring system (FGM) produces an ambulatory glucose profile (AGP) after download of glucose measurements from the sensor to the reader.3,4 AGP is a way to present the glucose data collected by time of day with several advantages: demonstrates median glucose levels at 25-75th as well as 10-90th percentiles as well as excursions and the tendency for hypo or hyperglycemia throughout the day. This integration of results gives a more complete picture of glucose control throughout the week/s while eliminating “noise” from outliers.3-5 We hereby report our experience using this technology in patients with difficult-to-control diabetes.
A total of 31 diabetic patients treated with multiple daily insulin injections with an HbA1C ≥7.5% used this CGM device to examine its possible beneficial effect on achieving target glucose levels and minimizing hypoglycemia. The patients had difficult-to-control type1/type 2 diabetes due to compliance/adherence difficulties, brittle diabetes, and fear of hypoglycemia. Patients were followed for 12 weeks in 3 centers in Israel: Diabetes Medical Center (DMC), diabetes clinic at Hadassah Hebrew University Hospital, and the diabetes clinic at Wolfson Hospital.
Study population consisted of 25 patients with type 2 diabetes and 6 patients with type 1 diabetes: 7 women, 24 men, average age 58 ± 16 years, average HbA1C at baseline 8.9 ± 0.26% (mean ± SE).
With the use of this FGM device there was major improvement in glucose control in both type 2 and type 1 diabetic patients: HbA1C decreased by −1.33 ± 0.29% at 8 weeks (mean ± SE respectively, P < .0001) and plateaued thereafter. For those patients who continued using the device (n = 27), the change was maintained for 24 weeks,–1.21 ± 0.42% (P = .009) (Figure 1). There were no events of major hypoglycemia. All patients were satisfied and most (n = 27/31) completed the 6 months of the experience. At the end of 3-6 months of follow-up, patients completed questionnaires: all patients (n = 31) were highly satisfied and stated that they would like to use this FGM device in the future. In addition, the patients unanimously stated that it was easy to use and painless.
Figure 1.
Mean HbA1C during follow-up.
The physicians in each center stated that this FGM device, and particularly the AGP presentation of data, was an outstanding tool, enabling better and easier control of glucose levels.
In conclusion, use of this FGM device remarkably improved glucose control in our cohort of patients with difficult-to-control diabetes. Further larger controlled studies are warranted to examine closely the effect on glucose variability, known to be an important contributor to diabetic complications.
Footnotes
Abbreviations: AGP, ambulatory glucose profile; CGMs, continuous glucose monitoring systems; FGM, flash glucose monitoring system; HbA1C, glycated hemoglobin; SMBG, self-monitoring of blood glucose.
Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MIS discloses the following relationships: advisory board: Novo Nordisk, Eli Lilly, Sanofi, Merck Sharp Dohme (MSD), Astra Zeneca; research grants from MSD and Bristol Myers Squibb (via Israel Diabetes Association)JW has no conflicts to declare. IR discloses the following relationships: Advisory Board: AstraZeneca/Bristol-Meyers Squibb, Eli Lilly and Company, Merck Sharp & Dohme Limited, Novo Nordisk, Inc., Sanofi, Orgenesis, SmartZyme Innovation Ltd, Labstyle Innovations Ltd, Boehringer Ingelheim; Consultant: AstraZeneca/Bristol-Meyers Squibb, Insuline Medical, Gili Medical, Kamada Ltd, FuturRx Ltd, Nephrogenex Inc.,Diabetes Medical Center (Tel Aviv, Israel); Speaker’s Bureau: AstraZeneca/Bristol-Meyers Squibb, Eli Lilly and Company, Johnson & Johnson, Merck Sharp & Dohme Limited, Novartis Pharma AG, Novo Nordisk, Inc., Sanofi, Teva, Boehringer Ingelheim; Stock/Shareholder: Insuline Medical, Labstyle Innovations, SmartZyme Innovation Ltd, Orgenesis, Glucome Ltd
OM discloses the following relationships: advisory board: Novo Nordisk, Eli Lilly, Sanofi, MSD, BI, Jansen and Jansen, Novartis, Astra Zeneca; grants paid to institution as study physician by Astra Zeneca and Bristol-Myers Squibb; research grant support through Hadassah Hebrew University Hospital: Novo Nordisk; speaker’s bureau: Astra Zeneca and Bristol-Myers Squibb, Novo Nordisk, Eli Lilly, Sanofi, Novartis, MSD, BI.
Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Devices were supplied by Abbott Diabetes Care Ltd.
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