Comparison of accuracy between flash glucose monitoring and continuous glucose monitoring in patients with type 2 diabetes mellitus undergoing hemodialysis

IntroductionWe evaluated the accuracy and clinical utility of flash glucose monitoring (FGM) in comparison with continuous glucose monitoring (CGM) and self-monitoring blood glucose (SMBG) in patients with type 2 diabetes (T2D) undergoing hemodialysis (HD).MethodsSimultaneous FGM (FreeStyle LibrePro), CGM (iPro2) and SMBG were performed on 13 T2D research subjects.ResultsThere were good overall correlations between SMBG and FGM (64.7% and 30.8% within the A and B of Parkes Error Grid, respectively) and between SMBG and CGM (87.9% and 11.0% within the A and B, respectively). However, during HD, correlations between SMBG and FGM were only 49.7% and 37.2% within the A and B, respectively, while correlations of SMBG and CGM were 72.8% and 22.2% within the A and B, respectively. The percentage of FGM not in Zone A + B was more than 4 times higher than for CGM. The overall mean absolute relative difference (MARD) for FGM was 18.2%, this significantly higher than 11.2% for CGM. During HD, MARD for FGM was 22.8%, significantly higher than 15.0% for CGM.ConclusionFGM has good clinical agreement in T2D patients undergoing HD. However, the accuracy of FGM relative to SMBG was worse than that of CGM.     

应用动态血糖监测评估2型糖尿病患者的夜间低血糖

动态血糖监测系统(CGMS)监测1 147例2型糖尿病患者血糖变化.结果 显示,夜间低血糖多发生在22:00～2:00,与平均血糖及晚餐后3 h血糖负相关,晚餐后3 h血糖4.7 mmoL/L时发生夜间低血糖几率达50%.     

Use of continuous glucose monitoring in patients with type 1 diabetes

The prevalence of type 1 diabetes continues to increase worldwide at a rate higher than previously projected, while the number of patients achieving American Diabetes Association (ADA) glycated hemoglobin (A1c) goals remains suboptimal. There are numerous barriers to patients achieving A1c targets including increased frequency of severe hypoglycemia associated with lowering plasma glucose as measured by lower A1c values. Continuous glucose monitoring (CGM) was first approved for retrospective analysis and now has advanced to the next step in diabetes management with the approval of real-time glucose sensing. Real-time CGM, in short term studies, has been shown to decrease A1c values, improve glucose variability (GV), and minimize the time and number of hypoglycemic events in patients with type 1 diabetes. These products are approved for adjunctive use to self-monitoring of blood glucose (SMBG), but future long-term studies are needed to document their safety, efficacy, ability to replace SMBG as a tool of monitoring, and ultimately utility into closed-loop insulin delivery systems. New algorithms will need to be developed that account for rapid changes in the glucose values, so that accuracy of the sensor data can be maintained. In addition, for better clinical care and usage, algorithms also need to be developed for both patients and the providers to guide them for their ongoing diabetes care.     

Efficacy of continuous glucose monitoring system to detect unrecognized hypoglycemia in children and adolescents with type 1 diabetes

This retrospective study assessed 17 DM1 pediatric patients (15.76 +/- 4.5 years) submitted to 72 h continuous glucose monitoring system (CGMS) (Medtronic, CA). The aim of this study was to evaluate the accuracy of CGMS in children and adolescents with type 1 diabetes mellitus (DM1) and the efficacy of this method to detect unrecognized hypoglycemia in this population. It were analyzed capillary glycemia (CG) and CGMS sensors value; glycemic excursions; postprandial hyperglycemia; unrecognized hypoglycemia; complications and therapeutic management after CGMS. A1c levels were measured at the start and after 3 months of the study. Correlation coefficient during hypo, hyper, and normoglycemia and sensitivity/specificity was determined. The mean CG values were 213.8 +/- 63.4 mg/dl vs. 209.7 +/- 52.5 mg/dl by sensor, with statistical significance by Pearson's correlation (p < 0.001). There was no difference between CGMS and CG value in order to detect glycemic excursions (p = 0.32). The postprandial hyperglycemia and unrecognized hypoglycemia was detected in 66.7% and 56.2% of this patients, respectively. The correlation coefficient during hypoglycemia presented no statistical significance by Pearson's correlation (p = 0.29) vs. during hyperglycemia (p = 0.001). The CGMS sensor presented low sensitivity (63.3%) to detect hypoglycemia. This data showed important decreased level of A1c in this population 3 months after CGMS with statistical significance (p = 0.03). The CGMS showed to be a very safe method, well tolerated, with high accuracy in glycemic values and low complications rate. This results suggest that CGMS is a good method to identify postprandial hyperglycemia, to improve metabolic changes in therapeutics with significant impact in A1c of diabetic pediatric patients. This data confirmed the low sensitivity of CGMS to detect unrecognized hypoglycemia in pediatric DM1 patients.     

Intermittent-scanned continuous glucose monitoring with low glucose alarms decreases hypoglycemia incidence in middle-aged adults with type 1 diabetes in real-life setting

ObjectiveThere is limited real-life data demonstrating that hypo-/hyperglycemic alarms added to continuous glucose monitoring (CGM) improve metabolic control in adults with type 1 diabetes (T1D).We evaluated the usefulness of switching from a flash or intermittent-scanned continuous glucose monitoring (is-CGM) device without low or higher glucose alarms to a is-CGM device with alarms to prevent hypoglycemia in adults with T1D.MethodsIndividuals with T1D and fearful of hypoglycemia, prone to hypoglycemia unawareness, and/or experiencing severe hypoglycemia while using is-CGM Free Style Libre 1 (FSL1) were switched to FSL2 with individually-programmable low glucose alarms. The primary endpoint was the changes in % time below range (TBR%) <70 mg/dl [3.9 mmol/l] and <54 mg/dl [3.0 mmol/l] after 12 weeks on FSL2 compared with FSL1. Secondary endpoints were changes in % time in range (TIR% 70–180 mg/dl [3.9–10.0 mmol/l]), % time above range (TAR%) >180 [10.0 mmol/l], mean interstitial glucose, glycemic management indicator (GMI), interstitial glucose coefficient of variation (CV%), hemoglobin A1c, and sensor's scans/day.ResultsWe included 108 individuals (57.4 % men), aged 58.2 ± 17.3 [95 % CI: 55.0 to 61.5] years, with mean diabetes duration 25 ± 14.6 [95 % CI: 22.1 to 27.7] years. Among individuals, 40 (37.0 %) had hypoglycemia awareness with Clarke's score ≥4 and 19 (17.5 %) had a history of severe hypoglycemia. The median low glucose alarm threshold was 70 [IQR: 65–70] mg/dl (3.9 [IQR: 3.6–3.9] mmol/L). By comparison of first 12 weeks on FSL2 vs. last 12 weeks on FSL1, TBR% <70 mg/dl decreased from 4.5 ± 4.4 to 2.3 ± 2.8 % (p < 0.001), TBR% <54 mg/dl decreased from 1.4 ± 2.2 to 0.3 ± 0.9 % (p < 0.001). TIR% was not significantly different (51.5 ± 14.9 vs. 52.9 ± 16 % (p = 0.13)), nor was TAR% (43.8 ± 16.2 vs. 44.7 ± 16.5 % (p = 0.5)). CV% decreased from 39.4 ± 6.9 to 37.9 ± 6.1 % (p < 0.001). Those at risk for hypoglycemia (TBR >4 % and >1 %, respectively, at baseline) showed a significant decrease in the incidence of hypoglycemia <70 and <54 mg/dl (p < 0.0001). Patients' satisfaction with hypoglycemia alarms was high, since all individuals opted to pursue using individual alarm beyond the study period.ConclusionSwitching from FSL1 to FSL2 with low glucose alarms reduced the frequency of hypoglycemia in middle-age adults with T1D, particularly in those who were prone to hypoglycemia awareness or severe hypoglycemia.     

Continuous glucose monitoring in type 1 diabetes

Continuous glucose monitoring is becoming increasingly more widespread for the routine care of people with type 1 diabetes mellitus and may eventually be used in closed-loop artificial b-cell systems. The current “state of the art” of this technology, including accuracy, performance in clinical trials, limitations, and recommendations for use, is discussed for the two currently approved continuous glucose monitoring devices.     

动态血糖监测探讨2型糖尿病患者睡前血糖和夜间低血糖的关系

85例2型糖尿病患者使用动态血糖监测系统(CGMS)监测血糖,每例记录48-72 h,共计完整记录220 d。以睡前血糖≤4．4 mmol／L,≤5．0 mmoL／L,≤5．6 mmol／L,≤6．1 mmol／L,≤6．7 mmol／L,≤7．2 mmol／L,评估这些患者的夜间低血糖(《2．8 mmol／L)的发生情况。26例患者39夜发生夜间低血糖,他们的睡前血糖为(4．4±2．6)mmol／L(2．2-12．6 mmoL／L)。在睡前血糖≤6．7 mmol／L时ROC曲线下面积达最大值(0．359±0．046),其阳性预测值25．0％,阴性预测值91．7％。CGMS是诊断夜间无症状性低血糖的有效方法。     

Study on the correlation between continuous glucose monitoring indexes and urinary albumin/creatinine ratio in asymptomatic hypoglycemia patients with type 2 diabetes mellitus

<正>Objective To explore the correlation between continuous glucose monitoring indicators time within glucose target range(TIR),time glucose below target range(TBR) and urinary albumin/creatinine ratio(UACR) in type 2 diabetes mellitus(T2DM) patients with asymptomatic hypoglycemia.     

Impact of flash glucose monitoring on glycaemic control and quality of life in patients with type 1 diabetes: A 18-month follow-up in real life

We conducted a prospective observational study to evaluate the medium-term impact of the flash glucose monitoring system (FGM) in a type 1 diabetic population. We included 248 patients, switched from conventional blood glucose monitoring (BGM) to FGM. We evaluated glycaemic control at 2–4 (T1) and 5–11 (T2) months after initiation and at the last available visit (T3, 18 ± 4 months). We asked patients to fill in, at T0 and T2, two questionnaires based on the Diabetes Treatment Satisfaction Questionnaire; and on the Hypoglycaemia Fear Survey.Glycaemic control improved, from 8.1 ± 1.3% at T0 to 7.8 ± 1.2% at T1 (p < 0.001) and remained unchanged after. Average number of controls increased from 3.2 ± 1.2 BGM to 7.7 ± 3.9 at T1 (p < 0.001). We observed a modest decrease in daily insulin doses. We evidenced an increase in mild hypoglycaemic events, especially in well-controlled subjects, but no increase of severe events. Satisfaction score improved from 30.5 ± 7.7 points to 38.3 ± 5.1 points (p = 0.018), was correlated with the reduction in and was higher in less controlled patients at inclusion. “Behaviour” score regarding hypoglycaemias decrease from 5.7 ± 4.1 to 4.4 ± 3.6 points (p < 0.001).In conclusion, this 18-months study trial indicates that using the FGM technology in patients with T1D may improve glycaemic control, in real-life conditions, especially in less controlled patients. FGM was associated with an increase of patients’ satisfaction regarding treatment. Hypoglycaemic events, however, were not reduced in frequency. Therefore, the need for an educational team and a structure program in the management of this new technology remains mandatory.     

The use of continuous glucose monitoring in patients with type 2 diabetes

Since the late 1970s, self-monitoring of blood glucose has been the standard for assessing daily glycemic control. The first continuous glucose monitor became available in 1999. Numerous clinical trials have documented the benefits of continuous glucose monitoring (CGM) in patients with type 1 diabetes mellitus (DM). However, the data supporting the use of CGM in type 2 DM patients are less substantial. This review article examines the clinical evidence for using CGM in patients with type 2 DM. An extensive literature search was performed to identify relevant studies for this review. Articles published in English from 2000 to May 2010 were identified through searches of PubMed and International Pharmaceutical Abstracts databases using the search terms type 2 DM and continuous glucose monitoring. Relevant references were examined for additional articles. The literature search revealed 27 original articles and reviews, 12 of which were included in this review. Five out of the 12 studies reviewed showed a decrease in glycosylated hemoglobin using CGM in patients with type 2 DM. The use of CGM in patients with type 2 DM can improve glycemic control, but other benefits include modification of diet and exercise, detection of unrecognized hypoglycemia, and identification of hyperglycemia excursions.     

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

The present study evaluated the accuracy of interstitial glucose measurements by flash glucose monitoring (FGM) and continuous glucose monitoring (CGM). Five diabetes patients simultaneously underwent FGM (FreeStyle Libre Pro) and CGM (iPro?2), and their glucose levels were compared with venous blood and capillary blood glucose levels. The range of daily venous blood glucose levels (30 measurements) was 70–245 mg/dL, with a median of 138 mg/dL. There were good correlations of glucose levels measured by FGM (r² = 0.90, mean absolute relative difference 8.2 ± 5.6%), CGM (r² = 0.86, mean absolute relative difference 9.2 ± 9.1%) and capillary blood (r² = 0.87, mean absolute relative difference 7.2 ± 7.2%) with venous blood glucose levels. The accuracy of FGM measurements was also shown against CGM, with 99.9% of the FGM values (1,279 measurements) being within the Parkes error grid zones A and B. The results suggest that the accuracy of FGM is similar to that of CGM, and that FGM is a useful tool for determining daily glucose profile.     

动态监测新诊断2型糖尿病患者的血糖水平

目的　动态监测新诊断2型糖尿病(T2DM)患者血糖漂移的细节及波动趋势。　方法　采用动态血糖监测系统(CGMS)对40 例新诊断、未经干预治疗的T2DM患者进行连续71(43~90)小时的血糖监测。　结果　CGMS所测的血糖值与血浆血糖值及指端血糖值均呈显著正相关(r=0.92, r=0.93, P均<0.001)。患者一天中血糖较高的时间段为早餐后2 h及中、晚餐后3 h。6 am~< 11 am是血糖高峰最集中(52.5%)的时间段,而62.5%的血糖低谷值出现在1 am~ <6 am。血糖>7 8 及11.1 mmol/L所占的时间百分比分别为96(37~100)%和62(8~100)%。血糖>7.8 及11.1 mmol/L的时间百分比与HbA1c(9.8%±1.9%)均呈显著正相关(r=0.74, r=0.76,P均<0 001)。　结论　动态血糖监测能较详细地显示T2DM患者血糖水平波动的特征,对拟定更为合理的治疗方案提供临床依据。