ORIGINAL ARTICLE. Use of Freestyle Libre Pro TM Flash Glucose Monitoring System in Different Clinical Situations at a Diabetes Centre

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1 18 Journal of The Association of Physicians of India Vol. 65 August 217 ORIGINAL ARTICLE Use of Freestyle Libre Pro TM Flash itoring System in Different Clinical Situations at a Diabetes Centre Bangalore Srinivasan Ratna 1, Radhakrishnan Subashini 2, Ranjit Unnikrishnan 3, Viswanathan Mohan 4 Abstract Flash itoring (FGM) is a newly introduced itoring system. FGM provides both graphical representation of qualitative and quantitative changes in glucose levels occurring over 14-day period collapsed into single modal day graph as well as day by day graphs. In this report, we present our experience with FGM in different clinical situations. In our experience FGM is an extremely useful clinical tool for detection of glucose variability, hyperglycemia and hypoglycemia. It can also be used as an effective educational tool when the data from FGM is shared with the patient. This helps in motivating the patient in achieving better glycemic control. Introduction Adequate control of blood glucose levels largely depends upon frequent monitoring of control both at the clinic as well as at home by the patient. Self monitoring of blood glucose (SMBG), introduced in the 198s, is the most widely used method of all the glucose monitoring techniques. It is most useful in patients on multiple insulin doses or on continuous subcutaneous insulin pump. It may also be helpful for treatment or self management for patients using less frequent insulin injections or on non-insulin therapies. 1 SMBG however only gives point of test blood glucose measurements without predicting the direction or rate of change of blood glucose or a continuous monitoring. Moreover, the need for frequent painful finger pricks, issues with calibration and accuracy of the glucose meter as well as the cost of strips contribute to poor patient compliance. As the concept of glycemic variability and its importance evolved, techniques to measure glycemic variability have simultaneously been developed. 2,3 An example is the Continuous itoring System (CGMS) that has been in use for several years. 4 We have earlier reported on our initial experience with CGMS at our centre. 5 The limitations of the currently available CGMS devices include the need for multiple finger stick calibrations, pain at sensor insertion site, expense and the relatively short life of the sensor (up to 7 days only). 6 Flash itoring (FGM) is a newly introduced method Editorial Viewpoint Ambulatory glucose monitoring is a novel method for monitoring. It can be used to adjust drug dose. It can be useful to motivate the patient to achieve good glycemic control. of flash glucose monitoring. It combines inputs from multiple days of glucose data and collapses them into a 24-hour modal day period. It allows quick analysis of poor glycemic control and glycemic variability and can be used as a patient education tool. It consists of three parts: a disposable sensor, a hand-held reader and a proprietary software. The sensor is placed on the back of upper arm with the help of an applicator (Figure 1). The sensor has a small, flexible 4mm-long tip inserted just under the skin; it can be worn up to 14 days. Its amperometric electrochemical sensor measures glucose readings in the 4 to 5 mg/dl range every 15 minutes during the entire wear period and stores them. Using near field communication technology, the sensor data is downloaded into the reader. While the sensor is 1 Fellow, Dr. Mohan s Diabetes Specialities Centre, Chennai, Tamil Nadu; 2 Senior Biostatistician, Madras Diabetes Research Foundation, Chennai, Tamil Nadu; 3 Vice Chairman, Dr. Mohan s Diabetes Specialities Centre and Madras Diabetes Research Foundation, Chennai, Tamil Nadu; 4 President, Madras Diabetes Research Foundation and Chairman, Dr. Mohan s Diabetes Specialities Centre, Chennai, Tamil Nadu Received: ; Revised; ; Accepted:

2 Time in : 6: 12: 18: : : 6: 12: 18: : Time in Journal of The Association of Physicians of India Vol. 65 August single-use only, the reader can be used to collect data from multiple sensors. The report is generated by connecting the reader to a computer in which the software has been installed. The graphical data provided by FGM includes mean of glucose values at different point of day, a median curve representing the 5 th percentile and also the 75 th percentile and 25 th percentile curves defining the Inter Quartile Range (IQR). The width of the band between the 1 th and Fig. 1 : FGM showing sensor and reader 9 th percentile curve is an index of the glucose excursion (variability). The glycemic trends for individual days can also be obtained in a graphical way. For the purpose of this paper, we have also manually calculated the Mean Amplitude of Glycemic Expression (MAGE) as the arithmetic mean of differences between consecutive peaks and nadirs of the glucose readings. The MAGE was calculated by taking 24-hour glucose values of and we compared this with 24-hour glucose readings of, Days 1 and 14 were not considered, as they usually have only incomplete readings depending on time of application and removal. The aim of this paper is to show the use of FGM in a few clinical situations. Specifically, we report on cases illustrating the use of FGM in different types of diabetes. Case 1 (FGM in a Normal Person) This was a 61 year old person with normal glucose tolerance in whom FGM was applied for a few days to see the normal glycemic variability. His fasting plasma glucose (FPG) was 96 mg/dl, post prandial plasma glucose (PPPG) 128 mg/dl and HbA1c, 5.6%. The MAGE on was 37mg/dl with the lowest recorded glucose reading of 74 mg/dl and highest of 151 mg/dl during the days when he wore the FGM (Figures 2A and 2B). Case 2 (Type 2 diabetes of short duration) This was a 44 year old male patient with type 2 diabetes of 3 years duration, on Tab. Glimepiride 2 mg two times a day. His FPG was 162 mg/dl, PPPG 296 mg/dl and Daily Summary 14 May May 215 (5 days) : 6: 12: 18: : May May May 14 8 Time in 94 8% 2% % 97 84% 14% 2% 12 1% % % Daily Summary 7 January January 216 (15 days) 7 Jan 8 Jan 9 Jan 1 Jan : 6: 12: 18: : Pro % % 44% % 2% 66% % 4% 84% % % 76% Daily Summary 7 January January 216 (15 days) 2 15 Jan Jan 17 Jan 18 Jan Pro 15 42% 4% 54% % 6% 45% % 1% 53% % % 53% 17 May 18 May % % % 98 1% % % 11 Jan 12 Jan 13 Jan % 2% 6% % % 51% % % 47% 19 Jan 2 Jan 21 Jan % % 5% % % 19% 114 9% 6% 4% : 6: 12: 18: : 14 Jan % % 51% 7 January January % 2% 52% 14 May May 215 Fig. 2A: FGM in a normal person 11 94% 5% 1% : 6: 12: 18: : Fig. 3A: Type 2 diabetes of short duration 3 (mg/dl) MAGE :14 :59 1:44 2:29 3:14 3:59 4:44 5:29 6:14 6:59 7:44 8:29 9:14 9:59 1:44 11:29 12:14 12:59 13:44 14:29 15:14 15:59 16:44 17:29 18:14 18:59 19:44 2:29 21:14 21:59 22:44 23: Σ λ n if λ > ν MAGE 37 mg/dl λ = each blood glucose increase or decrease (nadir-peak or peak nadir) n = number of observations ν = 1 SD of mean glucose for 24-hr period mg/dl MAGE - 15 mg/dl 112 :13 1:13 2:13 3:13 4:13 5:13 6:13 7:13 8:13 9:13 1:13 11:13 12:13 13:13 14:13 15:13 16:13 17:13 18:13 19:13 2:13 21:13 22:13 23:13 Fig. 2B: MAGE on day 2 (Case 1) Fig. 3B: MAGE on day 2 (Case 2)

3 Time in Time in 2 Journal of The Association of Physicians of India Vol. 65 August MAGE 74 Serie mg/dl mg/dl MAGE 12 mg/dl : :45 1:3 2:15 3: 3:45 4:3 5:15 6: 6:45 7:3 8:15 9: 9:45 1:3 12: 13:3 15: 16:3 18: 19:3 2:15 21: 22:3 :13 1:13 2:13 3:13 4:13 5:13 6:13 7:13 8:13 9:13 1:13 11:13 12:13 13:13 14:13 15:13 16:13 17:13 18:13 19:13 2:13 21:13 22:13 23:13 Fig. 4B: MAGE on day 2 (Case 3) Fig. 3C: MAGE on day 13 (Case 2) May 27 May 28 May 29 May 3 May 31 May 1 Jun 2 Jun : 6: 12: 18: : : 6: 12: 18: : % % 86% % % 32% % % 59% 141 4% 2% 58% % 5% 46% % 1% 77% % % 82% % % 74% Fig. 4A: Long duration of type 2 diabetes HbA1c, 8.2%. He was started on Inj. Glargine 1 units at bedtime along with tab Glimepiride 2 mg + Metformin 5 mg two times a day in view of high blood glucose levels. His AGP (Figure 3A) shows high blood glucose levels during the first week, which improved during second week with no hypoglycemic episodes. The MAGE was 15 mg/ dl on which improved to 74 mg/dl on (Figure 3B and 3C). The dose of glargine was later reduced and eventually withdrawn. In this case AGP helped us to analyse the glycemic control after initiation of insulin and also helped to document improvement in glycemic variability. Case 3 (Type 2 diabetes of long duration) This was a 55 year old male patient with type 2 diabetes of 2 years duration with diabetic retinopathy, diabetic nephropathy, 3 Jun 4 Jun 5 Jun 6 Jun 7 Jun 8 Jun : 6: 12: 18: : : 6: 12: 18: : 7 January January % % 58% % % 77% 23 19% 1% 8% 27 28% % 72% 171 3% 3% 67% 111 1% % % % 1% 65% mg/dl systemic hypertension, ischaemic heart disease, dyslipidemia and hypothyroidism. His FPG was 227 mg/ dl, PPPG 236 mg/dl and HbA1c, 8.6%. He was on Inj Aspart 16U-8U-4U plus inj Glargine 28U at bedtime, along with Tab Gliclazide 3mg once a day and Tab Linagliptin 5 mg once a day. FGM was initiated for achieving a better glycemic control in view of the comorbidities especially organ related complications. FGM (Figure 4A) showed uncontrolled diabetes at several points of the day during the two week period. On (Figure 4B) MAGE was 12 mg/dl. On (Figure 4C) MAGE was still 158 mg/dl. Further adjustments were made in insulin doses based on sensor readings. The lab reports post treatment change were FPG 122 mg/dl, PPPG 15mg/dl and HbA1c of 7.7%. A second FGM sensor was initiated to know if the improved blood sugars were stable and within the expected range. The : :45 1:3 2:15 3: 3:45 4:3 5:15 6: 6:45 7:3 8:15 9: 9:45 1:3 12: 13:3 15: 16:3 18: 19:3 2:15 21: 22:3 Fig. 4C: MAGE on day 13 (Case 3) MAGE 158 mg/dl second FGM report (Figure 4D) shows much better control with less glycemic variability shown by reduction in MAGE to 83 mg/dl on (Figure 4E) to 86 mg/dl on (Figure 4F). In this patient, AGP, along with adjustment of dosage of drugs enabled us to achieve better glycemic control with a reduction in HbA1c level by.9%. Case 4 (Gestational Diabetes Mellitus) This was a 26 year primigravida diagnosed with gestational diabetes mellitus (GDM) in the second trimester of pregnancy. Her FPG was 125 mg/dl, PPPG-229 mg/dl and HbA1c, 5.8 mg/dl. She was started on Inj Biphasic insulin Aspart 8U--6U. FGM was initiated to monitor glycemic control during pregnancy. FGM showed (Figure 5A) high postprandial blood glucose during the day time, with few low blood glucose levels early morning during initial first week

4 Time in Time in : 6: 12: 18: : : 6: 12: 18: : Time in : 6: 12: 18: : : 6: 12: 18: : Time in Journal of The Association of Physicians of India Vol. 65 August Aug 27 Aug : 6: 12: 18: : % % % 12 94% 6% % 3 Sep 4 Sep : 6: 12: 18: : % 3% 33% % 5% 19% Aug 29 Aug 3 Aug 31 Aug % 31% 2% % % 32% % 4% 2% % 9% 2% 5 Sep 6 Sep 7 Sep % 6% 2% % % 19% % 4% 13% mg/dl MAGE 86 mg/dl 1 Sep % 7% 1% 8 Sep % 24% 4% Sep % 7% 18% : 6: 12: 18: : : 6: 12: 18: : Fig. 4D: Long duration of type 2 diabetes: A second FGM sensor August September % 8% 12% : :45 1:3 2:15 3: 3:45 4:3 5:15 6: 6:45 7:3 8:15 9: 9:45 1:3 12: 13:3 15: 16:3 18: 19:3 2:15 21: 22:3 Fig. 4F: MAGE on day 13 while wearing second sensor (Case 3) mg/dl : :45 1:3 2:15 3: 3:45 4:3 5:15 6: 6:45 7:3 8:15 9: 9:45 1:3 12: 13:3 15: 16:3 18: 19:3 2:15 21: 22:3 Fig. 4E: MAGE on day 2 while wearing second sensor (Case 3) period. During the second week of sensor use, there was significant improvement in the post prandial blood glucose levels with a few hypoglycaemic episodes persisting during early morning hours. The MAGE of 18 mg/dl on (Figure 5B), decreased to 59 mg/dl on (Figure 5C). The morning dose of insulin was increased to 1 U for further control of postprandial spikes, with reduction in the night dose in view of early morning hypoglycemia. s FGM enabled us to achieve strict glycemic control in pregnancy and detect the asymptomatic hypoglycemia which helped in insulin dose adjustment. Case 5 (Type 1 Diabetes) This was a 1 year old boy with Type 1 DM of 5 months duration. His blood glucose values were FPG 162 mg/dl, PPPG 174 mg/dl and HbA1c of 9.7%. He was on Inj Aspart 3U-3U-3U along with Inj 74 MAGE 83 mg/dl Glargine 8U at bedtime. FGM was initiated to see why his HbA1c was so high, in spite of relatively acceptable fasting and postprandial glucose levels. His FGM (Figure 6A) showed high blood sugar levels at several points during the day with occasional hypoglycemic episodes. The MAGE on was 88 mg/ dl (Figure 6B) and 284 mg/dl on (Figure 6C). This type of profile is characteristic of type 1 diabetes. The dose of insulin was adjusted to Inj Aspart 3U-2U-2U and Inj. Glargine 1 U. In this case, the FGM enabled us to detect wide fluctuations in the blood glucose levels and to improve the diabetes control by adjusting the insulin doses. Case 6 (Fibrocalculous Pancreatic Diabetes) This was a 55 year patient with fibrocalculous pancreatic diabetes of 18 years duration. His current 6 Aug 7 Aug 8 Aug 9 Aug 1 Aug 11 Aug 12 Aug 13 Aug % 38% 24% 99 47% 35% 18% 11 57% 19% 24% % 16% 25% % 1% 34% % 1% 3% % % 27% % 18% 25% Fig. 5A: Gestational diabetes mellitus 14 Aug 15 Aug 16 Aug 17 Aug 18 Aug 19 Aug 2 Aug medications were Inj Biphasic Isophane insulin 22U--8U. His FPG was 99 mg/dl, PPPG 252 mg/dl and HbA1c, 7%. FGM was initiated to study the blood sugar fluctuations. FGM showed high blood glucose levels during postprandial periods, with a few hypoglycemic episodes during early morning hours (Figure 7A). Even though HbA1c was 7%, AGP showed high glycemic variability with MAGE of 12 mg/dl on (Figure 7B) and 93 mg/dl on (Figure 7C). In this case, the FGM enabled us to visualize the day to day variability of blood glucose even when the patient s HbA1c was apparently under control and helped us to make adjustments in the dosage of insulin. Discussion 133 6% % 4% % 5% 21% 92 43% 48% 9% 84 32% 6% 8% 75 46% 53% 1% 89 51% 46% 3% 49 6% 94% % 17 55% 25% 2% In this paper we have presented 5 different clinical types of diabetes in which FGM was initiated and also 1 normal individual. The first case shows a normal glucose tolerant subject where there is

5 Time in Time in 22 Journal of The Association of Physicians of India Vol. 65 August 217 mg/dl :8 :53 1:38 2:23 3:8 3:53 4:38 5:23 6:8 6:53 7:38 8:23 9:8 9:53 1:38 11:23 12:8 12:53 13:38 14:23 15:8 15:53 16:38 17:23 18:8 18:53 19:38 2:23 21:8 21:53 22:38 23:23 MAGE 18 mg/dl 29 Aug 3 Aug 31 Aug 1 Sep 2 Sep 3 Sep 4 Sep 5 Sep : 6: 12: 18: : : 6: 12: 18: : 144 1% % % % 2% 32% 24 37% % 63% % % 72% % % 85% % % 81% % % 88% 24 36% % 64% 6 Sep 7 Sep 8 Sep 9 Sep 1 Sep 11 Sep 12 Sep : 6: 12: 18: : : 6: 12: 18: : 29 August September % % 92% 24 42% % 58% 26 27% % 73% % % 54% % 2% 65% % % 57% % 2% 55% % % 66% Fig. 5B: MAGE on day 2 (Case 4) Fig. 6A: Type 1 diabetes mg/dl MAGE 59 mg/dl mg/dl MAGE 88 mg/dl Fig. 5C: MAGE on day 13 (Case 4) practically very little fluctuation of glucose levels. The second case shows how, in a recent onset T2DM patient, after starting treatment, the MAGE dramatically decreased and the control of diabetes improved. Till such technology became available, physicians would only get a snapshot of the improvement based on occasional SMBG s that are done. Case 3 illustrates greater fluctuations in a T2DM patient with longer duration of diabetes. Case 5 shows the marked fluctuations in a case of type 1 diabetes illustrating the brittle diabetes in this patient. In contrast, Case 4, a patient with GDM shows how mild the diabetes is, and how quickly GDM responds to treatment. The case with FCPD demonstrates more fluctuations in glucose levels like the type 1 patient. The FGM is a very useful tool to learn about the glycemic status of the patient over a 14 day period after initiating or altering a patient s antidiabetic drug regimen. As it provides day to day information about blood glucose levels for 2 weeks after a clinic visit, this is Fig. 6B: MAGE on day 2 (Case 5) most useful to adjust dosage of drugs. It also helps us to educate and motivate the patients to achieve good glycemic control. Mazze et al 7 first introduced Universal Software report (Ambulatory Profile for systematic presentation of SMBG data) and this was further developed by the same group. 8 An expert panel of diabetes specialists has given recommendations for standardizing glucose reporting and analysis of FGM to optimize clinical decision making. 9 A study by European diabetologists supports the use of FGM for glucose data analysis and to take treatment decisions. 1 FGM is considered as a valuable tool in the case of patients with type 1 diabetes and type 2 diabetes who are on insulin to identify poor glycemic control, to detect hypoglycemia and to study glycemic variability. 11 It is now believed that the risk of complications of diabetes is not solely determined by exposure to sustained chronic hyperglycemia but also by the oxidative stress generated by glycemic variability. 12 The FGM provides an easy visual analysis of presence of glycemic variability. Glycemic variability is said to present when glucose values are widely spread, for example, when the IQR and 1th and 9th percentile curves cover a wider area. Asymptomatic hypoglycemia can be also detected. In this report, we calculated the intraday glycemic variability by manually calculating the MAGE. 13 By comparing MAGE on with that on we could analyse the effect of the treatment prescribed over the 2 week duration and make adjustments to the prescription given at the clinic 2 weeks earlier. In our experience, FGM helps us to easily visualize whether patient blood glucose level is within the target range. When FGM report is communicated to the patient, they can understand the glucose levels better and become more involved in diabetes management. This ultimately helps to reduce the

6 Time in Time in Journal of The Association of Physicians of India Vol. 65 August mg/dl MAGE 284 mg/dl mg/dl MAGE 12 mg/dl 5 :5 :5 1:35 2:2 3:5 3:5 4:35 5:2 6:5 6:5 7:35 8:2 9:5 9:5 1:35 11:2 12:5 12:5 13:35 14:2 15:5 15:5 16:35 17:2 18:5 18:5 19:35 2:2 21:5 21:5 22:35 23:2 5 4 :14 :59 1:44 2:29 3:14 3:59 4:44 5:29 6:14 6:59 7:44 8:29 9:14 9:59 1:44 11:29 12:14 12:59 13:44 14:29 15:14 15:59 16:44 17:29 18:14 18:59 19:44 2:29 21:14 21:59 22:44 23:29 Fig. 6C: MAGE on day 13 (Case 5) Fig. 7B: MAGE on day 2 (Case 6) 35 : 6: 12: 18: : 21 Jan 22 Jan 23 Jan 24 Jan 25 Jan 26 Jan Jan % 29% 19% 127 4% 18% 42% 156 4% 1% 5% % 1% 53% % 16% 56% % % 42% 135 6% 5% 35% 29 Jan 3 Jan 31 Jan 1 Feb 2 Feb 3 Feb 4 Feb : 6: 12: 18: : 14 8 : 6: 12: 18: : % 2% 59% % % 72% % 3% 73% 186 5% % 95% 18 24% 15% 61% % % 61% 18 3% % 7% mg/dl MAGE 93 mg/dl Jan 14 8 : 6: 12: 18: : 137 3% 27% 43% 21 January February % 8% 57% :14 :59 1:44 2:29 3:14 3:59 4:44 5:29 6:14 6:59 7:44 8:29 9:14 9:59 1:44 11:29 12:14 12:59 13:44 14:29 15:14 15:59 16:44 17:29 18:14 18:59 19:44 2:29 21:14 21:59 22:44 23:29 Fig. 7A: Fibrocalculous pancreatic diabetes fluctuations of glucose readings and to improve HbA1c values. We therefore feel that the FGM is an excellent new tool in the physician s armamentarium to assess response to therapy. This paper is an illustration of different scenarios where the Freestyle Libre Pro TM FGM system can be used in clinical practice. References 1. American Diabetes Association. Standards of medical care in diabetes 215. Diabetes Care 215; 38 (suppl 1):S1-S Radbard D, Bailey T, Jovanovic L, et al. Improved quality of glycemic control and reduced glycemic variability with use of continuous glucose monitoring. Diabetes Technology Ther 29; 11: Qu Y, Jacober S, Zhang Q, et al. Rate of hypoglycemia in insulin - treated Patients with Type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther 212; 14: Beck RW, Tamborlane WV, Bergenstal RM, et al. T1D Exchange Clinic Network. The T1D Exchange clinic registry. J Clin Endocrinol Metab 212; 97: Vidya K, Sudhir R, Mohan V. Continuous glucose monitoring system - useful but expensive tool in management of diabetes. J Assoc Physicians India 24; 52: Vaddiraju S, Burgess DJ, Tomazos I, et al. Technologies for continuous glucose monitoring: current problems and future promises. J Diabetes Sci Technol 21; 4: Mazze RS, Lucido D, Langer O, et al. Ambulatory glucose profile: representation of verified self-monitored blood glucose data. Diabetes Care 1987; 1: Mazze R, Strock E, Wesley D, et al. Characterizing glucose exposure for individuals with normal glucose tolerance using Continuous itoring and Ambulatory Profile analysis. Diabetes Technology Ther 28; 1: Fig. 7C: MAGE on day 13 (Case 6) 9. Bergenstal RM, Ahmann AJ, Bailey T, et al. Recommendations for standardizing glucose reporting and analysis to optimize clinical decision making in diabetes: the Ambulatory Profile (AGP). Diabetes Technol Ther 213; 15: Matthaei S. Assessing the value of the Ambulatory Profile in clinical practice. Br J Diabetes Vasc Dis 214; 14: Matthaei S, DeAlaiz RA, Bosi E, et al. Consensus recommendations for the use of Ambulatory Profile in clinical practice. Br J Diabetes Vasc Dis 214; nier L, Colette C. Glycemic variability: should we and can we prevent it? Diabetes Care 28; 31 (suppl 2):S nier L, Colette C, Owens DR. Glycemic variability: the third component of the dysglycemia in diabetes. Is it important? How to measure it? J Diabetes Sci Technol 28; 2:194-1.

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