Use Of Continuous Glucose Monitoring System Research Articles

1034-P: Access to Continuous Glucose Monitoring Systems in a Primary Care Clinic for Underserved Patients with Type 2 Diabetes—A Pilot Study

B-Disparities in diabetes care are well documented. Continuous Glucose Monitoring Systems (CGMs) have improved patient experience without the need for finger sticks and have been shown to effectively lower Hemoglobin A1c (HbA1c), decrease clinical inertia and decrease the number of hypoglycemic events. Medically underserved and historically marginalized persons are disproportionately affected by diabetes, yet limited data exist on use of CGMs in this population. M-We report a pilot initiative that brought CGM access (FreeStyle Libre 2) to a Federally Qualified Community Health Center (FQHC). Patients with type 2 diabetes and an HBA1c >8.0% were referred to be enrolled in CGM. Each patient had an initial nurse visit for device placement of FreeStyle Libre (FSL) and several follow up visits to review glycemic trends and make medication changes with a provider. Baseline HBA1c was collected and repeated at the end of the study. Provider and patient surveys were distributed at each visit. R-Fifty participants were enrolled in the CGM study and had FSL placed. The CGM active time was greater than 50% in 76% of participants and those who continued with CGM had an increase in active time. Initial mean A1C for the entire cohort was 9.64% and average glucose after 2 weeks was 195 mg/dl. Hypoglycemia, especially overnight, reduced overtime. The use of CGM data was associated with clinician-initiated medication changes. Provider surveys revealed an increase in likelihood of medication changes based on glycemic trends and patients reported better understanding of their disease process. C-This pilot study demonstrates the feasibility of utilizing diabetes technology (FreeStyle Libre 2) in underserved patients at a primary care clinic staffed with internal medicine residents, physicians, and nurse practitioners. CGM is beneficial in under resourced primary care outpatient settings to determine glycemic trends and make appropriate medication recommendations. Disclosure R.G.Sgroi: None. S.Gumireddy: None. W.Tan: None. R.Kaplan: None. Y.Milambwe: None. L.H.Rosoph: None. D.A.Salama: None. C.R.Feher: None. N.J.Rennert: None.

Real-Time Continuous Glucose Monitoring in the Hospital: A Real-World Experience.

Glycemic control in the hospital setting is imperative for improving outcomes among patients with diabetes. Bedside point-of-care (POC) glucose monitoring has remained the gold standard for decades, while only providing momentary glimpses into a patient's glycemic control. Continuous glucose monitoring (CGM) has been shown to improve glycemic control in the ambulatory setting. However, a paucity of inpatient experience and data remains a barrier to US Food and Drug Administration (FDA) approval and expanded/non-research use in the hospital setting. Amid the COVID-19 pandemic, the FDA exercised its enforcement discretion to not object to the use of CGM systems for the treatment of patients in hospital settings to support COVID-19 health care-related efforts to reduce viral exposure of health care workers. Following this announcement, Scripps Health, a large not-for-profit health care system in San Diego, California, implemented CGM as the new "standard of care" (CGM as SOC) for glucose monitoring and management in the hospital. The present report serves to (1) detail the implementation procedures for employing this new SOC; (2) describe the patients receiving CGM as SOC, their glycemic control, and hospital outcomes; and (3) share lessons learned over two years and nearly 900 hospital encounters involving CGM. Here, we conclude that CGM is feasible in the hospital setting by using a dedicated diabetes care team and the CGM technology with remote monitoring.

Непрерывная подкожная инфузия инсулина в послеоперационном периоде коронарного шунтирования

Aim. To assess an efficacy of continuous glucose monitoring system (CGMS) combined with insulin pump therapy for perioperative glycemic control after coronary artery bypass grafting (CABG). Design. Prospective comparative study. Materials and methods. We used CGMS for 72 hours in 105 patients with coronary artery disease including 52 ones with diabetes mellitus type 2 (DM2). Patients with DM2 were divided into 2 subgroups: insulin pump therapy (subgroup 1) and bolus intravenous insulin according to in-hospital protocol (subgroup 2). We analyzed pro-inflammatory markers, adipokines and incidence of postoperative complications in one hour, 12 hours, 7 days and 1 year after CABG. Results. Insulin pump therapy ensured target glycemia in most cases (62.5%) while bolus intravenous insulin injection was followed by normal glucose level in 21.4% of patients (p = 0.003). Insulin pump therapy significantly decreased highly sensitive C-reactive protein after 12 hours (p = 0.0001), RANTES after 7 days (p = 0.035). In patients on insulin pump therapy the leptin level after 7 days was significantly lower than in the subgroup 2 (p = 0.039). There was a negative relationship between the leptin level after 7 days and the use of CGMS combined with insulin pump therapy (r = –0.73; p = 0.025). In patients on insulin pump therapy the adiponectin level after 1 year was significantly higher than in the subgroup 2 (p = 0.028). Insulin pump therapy decreased the incidence of postpericardiotomy syndrome (p = 0.03) and the period of hospitalization (p = 0.007), but there was no significant difference in the rate of complications in the long-term period. Conclusion. CGMS combined with insulin pump therapy is safe and effective for perioperative glycemic control, as well as decrease of the incidence of postpericardiotomy syndrome. Keywords: coronary artery disease, diabetes mellitus type 2, coronary artery bypass surgery, insulin infusion system.

The role Time in range depending on the method of assessing glycemic control in diabetes: A review

Despite modern advances in diabetology, diabetes is a progressive non-communicable disease with the possible development of vascular complications, which is a global health problem. Therefore, maintaining optimal glycemic control is important for managing diabetes and preventing the development of acute and chronic complications of the disease. One of the parameters for assessing glycemic control is the indicator of time in the target range (Time in range TIR), calculated on the basis of data from continuous glucose monitoring (CGM), which is quite simple and convenient to calculate and use, and also has a proven connection with the development of micro- and macrovascular complications of diabetes. However, the main obstacle to the widespread use of TIR is the limited use of CGM systems. Therefore, of particular interest is the study of the derived indicator of the time in range of glycemia (derived TIR dTIR), obtained on the basis of self-monitoring of blood glucose. In this review, the issues of the relationship of TIR, dTIR with HbA1c levels, the development of micro- and macrovascular complications of diabetes type 1 and 2 are discussed, and the comparability of TIR and dTIR is analyzed.

Real-time continuous glucose monitoring systems in patients with type 1 diabetes. Expert group report

The beginning of the 21st century saw the arrival of continuous glucose monitoring systems (CGMS). For over a decade they were seen as an excellent tool providing data on the daily glucose profile patterns in patients with diabetes, but confined to research. Over 20 years ago hardly anyone expected CGMS to become an extremely useful device in everyday life with diabetes as the cost, the burdensome design and accuracy were at the time the main concerns. However, in the last few years CGMS has become available to the entire diabetic population, and it is affordable to many of them. During this time, the technology developed immensely, and patients can now use reliable systems to give them instant, online insight into their blood glucose excursions 24/7. Moreover, the accumulated evidence indicates that arming patients with knowledge of their current glucose value and the trends of its variability translates into significant improvement in overall glucose management. The patients who benefit most, as research data and clinical experience show, are those who are treated with insulin, in particular individuals with type 1 diabetes. Progress in glucose monitoring – the journey from measuring urine glucose through portable glucose meters to CGMS – has also changed the metrics that are used to assess metabolic control of diabetes. In recent years the concept of time in range (TIR) has been introduced, which is now being widely adopted into clinical guidelines and practice. In 2021 the use of real-time CMGS in patients with type 1 diabetes was recommended by the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) as a main tool for self-monitoring of blood glucose. The article is a state-of-the-art review presenting current evidence-based knowledge and views on the practical use of CGMS in this group of patients, with clinical implications and opportunities discussed in detail.

Newest Diabetes-Related Technologies for Pediatric Type 1 Diabetes and Its Impact on Routine Care: a Narrative Synthesis of the Literature.

Purpose of ReviewThis review aims to address the actual state of the most advanced diabetes devices, as follows: continuous subcutaneous insulin infusions (CSII), continuous glucose monitoring systems (CGM), hybrid-closed loop (HCL) systems, and “Do-it-yourself” Artificial Pancreas Systems (DIYAPS) in children, adolescents, and young adults. This review has also the objective to assess the use of telemedicine for diabetes care across three different areas: education, social media, and daily care.Recent FindingsRecent advances in diabetes technology after integration of CSII with CGM have increased the popularity of this treatment modality in pediatric age and shifted the standard diabetes management in many countries. We found an impressive transition from the use of CSII and/or CGM only to integrative devices with automated delivery systems. Although much has changed over the past 5 years, including a pandemic period that precipitated a broader use of telemedicine in diabetes care, some advances in technology may still be an additional burden of care for providers, patients, and caregivers. The extent of a higher rate of “auto-mode” use in diabetes devices while using the HCL/DIYAPS is essential to reduce the burden of diabetes treatment.SummaryMore studies including higher-risk populations are needed, and efforts should be taken to ensure proper access to cost-effective advanced technology on diabetes care.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40124-021-00248-7.

Reliability of continuous glucose monitoring system in the inpatient setting

Aims/HypothesisHyperglycemia and hypoglycemia are associated with increased morbidity and mortality in the inpatient setting. Standard point of care capillary glucose testing (POCT) is commonly used in hospitalized patients to monitor their glucose levels. The goal of this study was to examine the relationships between the glucose readings obtained by a continuous glucose monitoring system (CGMS) (Freestyle Libre) and the capillary blood glucose results obtained by the inpatient glucose POCT meter (Accuchek Inform II) as well as between CGMS readings and the serum glucose values obtained by the hospital laboratory. Study participants had either primary or secondary diagnosis of diabetes mellitus and were admitted to non-critical units. We hypothesized that there exists an acceptable agreement between the capillary blood glucose results obtained by the inpatient glucose POCT meter (Accuchek Inform II) and the readings obtained by the CGMS (Freestyle Libre); and that there exists an acceptable agreement between the serum glucose levels and the glucose values obtained by the CGMS. MethodsThis was an Institutional Review Board approved prospective cohort study for the non– critical inpatient setting. Fifty-two hospitalized patients with diabetes were recruited. After informed consent was obtained, patients were instructed on the application and use of the CGMS. The data were assessed using a standard regression analysis and modified Bland Altman analysis. All analyses were conducted using SAS, release 3.8 Enterprise Edition (SAS Institute Inc., Cary, NC). ResultsFifty-two subjects recruited into the study represented a sample of convenience. There were a total of 467 AccuChek-Libre pairs, The regression analysis showed a negative bias between.Libre and AccuChek, R2 = 0.83, with Libre glucose readings on average being lower than those of AccuChek. Using Bland-Altman analysis, 42% of the 467 Libre-AccuChek pairs had a difference in glucose reading more than 15%. Mean absolute relative difference (MARD) between Libre and AccuChek was 15.6%; mean relative difference (MRD) between Libre and AccuChek was −11.4%.The regression analysis showed a negative bias between Libre and serum glucose, R2 = 0.89. Using Bland Altman analysis, 36% of the 44 Libre-serum pairs had a difference in glucose reading more than 15%. Mean absolute relative difference (MARD) between Libre and serum glucose was 13.2%; mean relative difference (MRD) between Libre and serum glucose was −12.5%.A review of the data pairs showed that 71/467 Accuchek-Libre pairs had one result that was either below 70 mg/dl or above 200 mg/dl (combined American Diabetes Association-ADA-, American College of Physicians-ACP- and American College of Endocrinology-AACE- goals). Thus 85%, of these pairs would have yielded results that engendered the same intervention (e.g. treatment for hypoglycemia or hyperglycemia). Likewise 5/45 Serum-Libre pairs had one result that was either below 70 mg/dl or above 200 mg/dl; thus 89% of these pairs would have yielded results requiring the same intervention. Conclusion/InterpretationThese findings confirm the existent literature and indicate acceptable agreement between the standard POCT and the CGMS as well as between serum glucose and the CGMS values. Because of the advantages of the CGMS over capillary blood glucose testing (reduced patient discomfort and reduced staff exposure to patients in isolation) CGMS use may be preferable to the current bedside capillary blood glucose testing in hospitalized patients with diabetes mellitus. As with other laboratory measures, clinical judgement needs to be exercised when the laboratory values are used to guide patient care.

Insulin protocol to control post-pancreatectomy diabetes

Diabetes is a disease by which blood glucose level is elevated by defects in insulin secretion or by resistance to insulin. As pancreatectomy inevitably results in the reduction of the total islet mass, the majority of clinicians tended to believe that pancreatectomy itself would immediately cause blood glucose elevation and subsequent diabetes development. In partial pancreatectomy surgery (distal pancreatectomy or PPPD), however, not all patients develop diabetes for at least a number of years after. This is because the remnant pancreatic islets can produce relatively enough amount of insulin to maintain blood glucose level. After this compensatory time period passes after partial pancreatectomy, the pancreas eventually undergoes atrophy after surgery and the insulin secretory function decreases in the remnant islet. This will lead to delayed development of diabetes after pancreatectomy. Under these situations, insulin injection together with oral anti-diabetic medication would be critical for controlling the blood glucose level. In contrast, patients who undergo total pancreatectomy will develop diabetes immediately after the surgery because of the absolute deficiency of insulin. In this situation, the patients will need a tightly-controlled, delicate insulin injection protocol with multiple subcutaneous insulin injections. Recently, with only a small patch applied to the body, continuous glucose monitoring system (CGMS) enables the reporting of the blood glucose level into the patient's smartphone every 1-5 minutes. The CGMS has gained popularity, is clinically helpful, and is even supported by the health insurance system for type 1 diabetes patients (the patients who undergoes total pancreatectomy can be categorized as type 1 diabetes by the Health Insurance Review System). In this lecture, I will be addressing the different glucose management protocols and/or methods in a variety of pancreatectomy cases and will also introduce the usefulness of CGMS for total pancreatectomy patients.

Blood glucose and subcutaneous continuous glucose monitoring in critically ill horses: A pilot study

This pilot prospective study reports the feasibility, management and cost of the use of a continuous glucose monitoring (CGM) system in critically ill adult horses and foals. We compared the glucose measurements obtained by the CGM device with blood glucose (BG) concentrations. Neonatal foals (0-2 weeks of age) and adult horses (> 1 year old) admitted in the period of March-May 2016 with clinical and laboratory parameters compatible with systemic inflammatory response syndrome (SIRS) were included. Glucose concentration was monitored every 4 hours on blood samples with a point-of-care (POC) glucometer and with a blood gas analyzer. A CGM system was also placed on six adults and four foals but recordings were successfully obtained only in four adults and one foal. Glucose concentrations corresponded fairly well between BG and CGM, however, there appeared to be a lag time for interstitial glucose levels. Fluctuations of glucose in the interstitial fluid did not always follow the same trend as BG. CGM identified peaks and drops that would have been missed with conventional glucose monitoring. The use of CGM system is feasible in ill horses and may provide clinically relevant information on glucose levels, but there are several challenges that need to be resolved for the system to gain more widespread usability.

Use of continuous glucose monitoring to improve glycemic management: A clinician's guide

AbstractAdoption of continuous glucose monitoring (CGM) technology in clinical practice has increased over the past few years with numerous studies demonstrating its benefit in persons with diabetes. In addition, the use of CGM systems is now recommended in multiple guidelines for diabetes care. Implementation of personal‐ and professional‐use CGM technology can facilitate patient‐centered discussions in clinical decision making and empower behavioral change. Pharmacists can incorporate CGM into diabetes management practices to help optimize therapy and overcome therapeutic inertia. This “how to” guide is written for pharmacists who are interested in integrating CGM into their clinical practice to improve care for those living with diabetes. It provides an overview of the different CGM systems available and describes the differences between personal‐ and professional‐use CGM to facilitate decision making for use in clinical practice. It also discusses considerations for use, candidates for coverage, billing for CGM services, data interpretation, and documentation. Lessons learned and advice for implementing into clinical practice are also provided.

Basics and use of continuous glucose monitoring (CGM) in diabetes therapy

Abstract Background For a long time, self-monitoring of blood glucose (SMBG) was widely viewed as the essential glucose measurement procedure in the therapy of insulin-treated people with diabetes. With increasing accuracy and simplified handling of continuous glucose monitoring (CGM) systems, this evolving technology challenges and at least partly replaces SMBG systems. Content Sensors of all currently available CGM systems measure glucose levels in the subcutaneous interstitial fluid for 6–14 days. The only available implantable sensor facilitates a measurement span of up to 6 months. Depending on the used system, glucose levels are either shown in real time (rtCGM systems) or after scanning (iscCGM systems). Functions such as alerts, alarms and trend arrows and data presentation encourage independent self-management of diabetes therapy. The high frequency of glucose data and the multitude of existing functions require an extensive training of people with diabetes and their caregivers. Summary CGM systems provide a much more detailed picture of glycemia in people with diabetes. Educated patients can use these data to react adequately to their glucose levels and therefore avoid hypoglycemic and hyperglycemic events. Studies showed that glycated hemoglobin (HbA1c) levels and hypoglycemic events can be significantly reduced by frequent use of CGM systems.

"Out of the box" solution for skin problems due to glucose-monitoring technology in youth with type 1 diabetes: real-life experience with fluticasone spray.

Use of a continuous glucose-monitoring system (CGMS) in the management of type 1 diabetes (T1D) may cause local skin irritation. To examine the effects of fluticasone propionate aqueous nasal solution (nsFP), sprayed topically prior to CGMS insertion among youth with T1D. This is a case series observational report, including real-life 6-month follow-up data from one pediatric diabetes center. All patients suffering from local skin irritation due to CGMS adhesives were offered prevention form skin irritation by spraying 2 puffs of nsFP on the skin area prior to adhesion of CGMS. Data were collected from their charts after 6months. Outcome measures included the difference in degree of skin irritation, number of days of CGMS use, BMI SDS, mean glucose, and HbA1c, prior to use and during 6months after use. Twelve patients used nsFP prior to CGMS insertion, mean age 8.6 ± 4.9years and 66.7% males. Ten patients, median age 6.1years (5.3-9.5) and 56% males, continued using nsFP for a mean of 0.56 ± 0.11years, with no recurrence of local irritation nor dermatitis to same adhesive material. No differences were found before and after use of nsFP in CGMS mean glucose 180mg/dl (153-202) versus 165mg/dl (150-192). BMI SDS was slightly higher 0.44 (- 0.9-1.2) versus 0.25 (- 0.47-1.06), P = 0.05. This small-scale, single-site description of a simple intervention by nsFP and favorable outcome provides valuable insight for a simple solution for skin irritation and dermatitis in the pediatric population with T1D.

376-P: Type 2 Diabetes Individuals Are at High Risk of Continuous Glucose Monitoring Detected Hypoglycemia Regardless of Degree of Metabolic Control

Type 2 diabetes patients, especially those with poor metabolic control or treated with oral hypoglycemic agents (OHA) only are often regarded as being at lower risk of hypoglycemia than type 1 diabetes subjects. We used continuous glucose monitoring system (CGMS) in 69 type 2 diabetes individuals (mean [±SD] age 63±9 years, duration of diabetes 12±7 years, BMI 31.8±5.2 kg/m2, HbA1c 8.4±0.7%, 74% treated with insulin ± OHA, 26% - treated with OHA only, including sulfonylureas) to assess the hypoglycemia prevalence. Each patient underwent blinded CGMS (iPro2, Medtronic) for 5.8±0.8 days, duration of the time spent at blood glucose (BG) <70 mg/dl was determined and expressed as a percentage of total CGMS use time (T hypo). Clinically statistical hypoglycemia (CSH) episodes defined as BG <54 mg/dl lasting >15 minutes were also recorded. Overall, hypoglycemia was detected in 28 (40.6%) patients, including five treated with OHA only. T hypo ranged from 1 to 15% (6.1±4.7%), and was twice as long in insulin treated individuals than in those on OHA only (8.8±5.1 vs. 4.2±3.6; p<0.05). 57% of all patients experiencing hypoglycemia (including two treated with OHA only) had at least one episode of nocturnal CSH, with BG as low as 40 mg/dl, and none was symptomatic. To assess the relationship between hypoglycemia risk and degree of metabolic control the study subjects were divided into two subgroups: with good (n=29; HbA1c 7.2±0.6, range 6-8%) and poor (n=40; HbA1c 9.6±0.8, range 9-12%) metabolic control. Hypoglycemia was recorded in 37.9 and 42.5%, nocturnal hypoglycemia - in 54.5 and 58.8% of subjects from each group, and T hypo was 6.7±4.9 and 5.7±4.6%, respectively (p>0.05). In conclusion, 40% of type 2 diabetes individuals experience hypoglycemia when assessed with CGMS for 5-6 days, with majority having asymptomatic nighttime events. Importantly, the high prevalence of CGMS detected hypoglycemia was not related to the degree of metabolic control of diabetes. Disclosure E. Szymanska-Garbacz: None. A. Borkowska: None. L. Czupryniak: None.

MON-134 Use of CGMS for Evaluating Hypoglycemia in Non-Diabetic Patients

Introduction: Continuous Glucose Monitoring System (CGMS), is a tool for measuring blood glucose (BG) levels in patients with Diabetes Mellitus (DM). Post-prandial Hypoglycemia (PPH) is a known complication of Roux-en-Y gastric bypass (RYGB). We present two cases of PPH following RYGB, confirmed by CGMS. Case 1: 70-year-old non-diabetic male, with RYGB 20 yrs. ago, presented with episodes of tremors, generalized weakness and blurring of vision, lasting about 10-15 min, occurring after eating simple carbohydrate foods. Onset and duration of episodes were unclear. In clinic, a POCT BG was 40 mg/dl with symptoms after eating doughnuts prior to the visit. VS- BP 122/58 Sitting, BP 108/57 Standing, P 87/m, Wt. 70.9 kg, BMI 22.mkg/m². Labs: BG 74 mg/dL, Sulphonylurea screen-negative, Cortisol AM 15.4 ug/dL, ACTH 23 pg/mL, C-Peptide 1.31 ng/mL (nl 0.81 - 3.85), Fasting Insulin 4.5 mIU/L (nl 0.0 - 24.9), IGF-I 76 ng/mL (nl 41 - 279), IGF-II 299 ng/mL (nl 267 - 616), BOH-butyrate 0.377 mmol/L (nl 0.020 - 0.270); IA-2 Ab <0.8U/mL (nl <0.8 U/mL). CGMS for 15 days-multiple episodes of PPH. Patient was advised to follow high protein, low carbohydrate diet, later started with Acarbose therapy. CGMS was repeated 3 months later, with marked reductions in PPH. Case 2: 32-year-old male, with RYBG 5 years ago, resulting in 150 lbs. weight loss, presented to clinic for progressive episodes of hypoglycemia. He did not test BG on a regular basis, but when tested occasionally in the morning, reported BG were 90-199 mg/dl, unless he skipped a bedtime snack. Patient reported having one episode when he woke up in the middle of the night “jittery and sweaty,” and BG was 37 mg/dl. His symptoms resolved after juice. He reports not being able to eat large meals and has been eating frequent small meals. He noted symptoms of hypoglycemia, when he eats simple carbohydrates. He also reported some high BG levels (170-180 mg/dl) although he is not previously known to have DM. VS-BP 115/67, HR 67; no orthostasis; Wt 287 lbs, BMI 45. Kg/m². POCT Glucose 64, Fasting Labs: BG 86 mg/dL, HbA1C 5.8%, C-Peptide 1.48 ng/mL, BOH-butyrate 0.7 mmol/L, Cortisol AM 12.2 ug/dL, Insulin Fasting 8.0 mIU/L, Proinsulin 2.4 pmol/L (nl ≤8.0), Insulin Antibody <0.4U/mL (nl 0.0-0.4 U/mL). CGMS for 2 weeks demonstrated repeated PPH and nocturnal hypoglycemia. Diet changes were recommended. Discussion: CGMS compared to blood glucose monitoring, is more efficacious in recording hypoglycemic events, especially if hypoglycemia occurs between testing times, or in usual settings like PPH. Current guidelines recommend use of CGMS in DM patients with hypoglycemic unawareness, nocturnal hypoglycemia, postprandial hyperglycemia. In our cases, CGMS was proven to be effective in diagnosing PPH in RYBG patients. CGMS is also an efficient device to measure therapeutic responses and avoiding hypoglycemia, as well as improving quality of life.

Self-measurement of Blood Glucose and Continuous Glucose Monitoring - Is There Only One Future?

Monitoring glycaemic control in patients with diabetes has evolved dramatically over the past decades. The introduction of easy-to-use systems for self-monitoring of blood glucose (SMBG) utilising capillary blood samples has resulted in the availability of a wide range of systems, providing different measurement quality. Systems for continuous glucose monitoring (CGM) – used mainly in patients with type 1 diabetes (T1D) – were made possible by the development of glucose sensors that measure glucose levels in the interstitial fluid (ISF) in the subcutaneous tissue of the skin. CGM readings might not correspond exactly to SMBG measurement results taken at the same time, especially during rapid changes in either blood glucose or ISF glucose levels. The mean absolute relative difference is the most popular method used for characterising the measurement performance of CGM systems. Unlike the International Organization for Standardization 15197:2013 criteria for SMBG systems, no accuracy standards for CGM systems exist. Measurement quality of CGM systems can vary based on several factors, limiting their safety and effective use in managing diabetes. Patients have to be trained adequately to make safe and efficient use of CGM systems (like with SMBG systems). Also, systems for CGM must be evaluated in terms of patient safety and the ability to provide accurate measurements regardless of the fluctuation of glucose levels. As new technological advancements in glucose monitoring are essential for improved management options of diabetes, such as automated insulin dosing systems, there is a need for a critical view of all such developments. It is likely that both, SMBG and CGM systems, will play important future roles in the treatment of diabetes.

Utilité de la mesure en continu de la glycémie chez les patients diabétiques de type 2

Management of type 1 and type 2 diabetes mellitus is getting complex with the apparition of new treatments, but also new technologies. Among these, continuous glucose monitoring systems (CGMS) lead to a better glycemic control and less hypoglycemia in type 1 diabetic patients. Studies are scarce in type 2 diabetes but also seem to show a benefit, particularly in patients using insulin. Nevertheless, type 2 diabetic patients taking advantage of CGMS must be better defined. In any case, a multidisciplinary approach to the use of CGMS and interpretation of data is warranted.

SPECTRUM.

Optimal usage of continuous glucose monitoring (CGM) requires adequate training of the users. Providing patients with a CGM system without such a training usually doesn't lead to the intended improvement in metabolic control. In Germany we developed a structured training program ("SPECTRUM") to ensure a high quality standard for the use of CGM systems. This program is suitably for patients of all age groups and is applicable to all CGM systems and all forms of insulin therapy. A curriculum was also developed so that training centers with less experience with CGM could become capable of offering comprehensive CGM training. We believe that usage of such a program can be an important step forward in achieving more widespread acceptance and use of CGM systems. Translations in other languages and evaluation with a controlled clinical trial are planned.

Test-retest reliability of a continuous glucose monitoring system in individuals with type 2 diabetes.

This study determined the test-retest reliability of a continuous glucose monitoring system (CGMS) (iPro™2; Medtronic, Northridge, CA) under standardized conditions in individuals with type 2 diabetes (T2D). Fourteen individuals with T2D spent two nonconsecutive days in a calorimetry unit. On both days, meals, medication, and exercise were standardized. Glucose concentrations were measured continuously by CGMS, from which daily mean glucose concentration (GLU(mean)), time spent in hyperglycemia (t(>10.0 mmol/L)), and meal, exercise, and nocturnal mean glucose concentrations, as well as glycemic variability (SD(w), percentage coefficient of variation [%cv(w)], mean amplitude of glycemic excursions [MAGEc, MAGE(ave), and MAGE(abs.gos)], and continuous overlapping net glycemic action [CONGA(n)]) were estimated. Absolute and relative reliabilities were investigated using coefficient of variation (CV) and intraclass correlation, respectively. Relative reliability ranged from 0.77 to 0.95 (P<0.05) for GLU(mean) and meal, exercise, and nocturnal glycemia with CV ranging from 3.9% to 11.7%. Despite significant relative reliability (R=0.93; P<0.01), t(>10.0 mmol/L) showed larger CV (54.7%). Among the different glycemic variability measures, a significant between-day difference was observed in MAGEc, MAGE(ave), CONGA6, and CONGA12. The remaining measures (i.e., SD(w), %cv(w), MAGE(abs.gos), and CONGA1-4) indicated no between-day differences and significant relative reliability. In individuals with T2D, CGMS-estimated glycemic profiles were characterized by high relative and absolute reliability for both daily and shorter-term measurements as represented by GLUmean and meal, exercise, and nocturnal glycemia. Among the different methods to calculate glycemic variability, our results showed SD(w), %cv(w), MAGE(abs.gos), and CONGAn with n ≤ 4 were reliable measures. These results suggest the usefulness of CGMS in clinical trials utilizing repeated measured.

Factors associated with glycemic control in adult type 1 diabetes patients treated with insulin pump therapy.

Continuous subcutaneous insulin infusion (CSII) by insulin pump seems to improve glycemia and quality of life as compared to conventional insulin therapy in type 1 diabetes (T1DM). However, while many T1DM subjects achieve excellent glycemic control, some others cannot reach recommended goals. In a retrospective analysis, we searched for factors associated with glycemic control in T1DM patients treated with insulin pump therapy. Data from 192 patients (133 women and 59 men) treated with personal insulin pumps at the Department of Metabolic Diseases, University Hospital, Krakow, Poland were analyzed. Sources of information included medical records, memory read-outs from insulin pumps and data from glucose meters. Univariate, multivariate linear and logistic regression analysis for the association with hemoglobin A1c (HbA1c) level were performed. The mean age of the subjects was 28.9 (±11.2) years, the mean duration of T1DM-14.6 (±7.6) years, mean body mass index-23.5 (±3.1) kg/m2. The mean HbA1c level in the entire study group was 7.4% (57 mmol/mol). In the multivariate linear regression analysis, HbA1c correlated with the mean number of daily blood glucose measurements, number of hypoglycemic episodes per 100 blood glucose measurements, age at the examination, and continuous glucose monitoring system use. Multivariate logistic regression analysis for reaching the therapeutic target of HbA1c<7.0% (53 mmol/mol) showed that the independent predictors of achieving this goal included the same four variables. In a large clinical observation, we identified that patient-related and technological factors associated with glycemic control in adult pump-treated T1DM subjects.

Parental sleep quality and continuous glucose monitoring system use in children with type 1 diabetes

To compare sleep quality and sleep-wake patterns in parents of children with type 1 diabetes before routine use of the continuous glucose monitoring system (CGMS) and while using it. Thirteen parents completed the Pittsburg Sleep Quality Index (PSQI), a 7-day sleep diary, and wore an actigraph (a wristwatch-size motion detector) during the night for 1week before pediatric use of CGMS and 4-8weeks after initiating routine use of the CGMS. Mean age of parents (ten mothers, three fathers) was 39 (range 32-47) years; mean age of children was 9.3years (range 5.5-16.5years); mean disease duration was 3.4 (range 0.6-11.2) years. PSQI total score demonstrated similar quality of sleep with and without use of the CGMS (4.6 and 4.9, respectively, p=0.45). Six of the 13 parents reported severe sleep problems (PSQI≥5) with and without the CGMS. The sleep diary indicated a greater number of awakening episodes during CGMS use than without the CGMS (1.6 and 1, respectively, p=0.03), and actigraphy documented an increase in the number of wake bouts (22.9 and 19.7, p=0.03) as well as in total wake time (48.3 and 42.2min, p=0.03) during CGMS use as compared with the period prior to CGMS use. Although self-perception of sleep quality remained unchanged, CGMS use appeared to affect actual parental sleep continuity somewhat negatively. This should be made clear to parents who may hold expectations of improvement in sleep quality following initiation of CGMS use.