Real-time Continuous Glucose Research Articles

Does real time continuous glucose monitoring improve glycaemic control in patients with Wolfram syndrome and insulin dependent diabetes mellitus?

Does real time continuous glucose monitoring improve glycaemic control in patients with Wolfram syndrome and insulin dependent diabetes mellitus?

Real time continuous glucose monitoring in high-risk people with insulin-requiring type 2 diabetes: A randomised controlled trial.

To investigate the impact of real-time continuous glucose monitoring (rtCGM) on glycaemia in a predominantly indigenous (Māori) population of adults with insulin-requiring type 2 diabetes (T2D) in New Zealand. Twelve-week, multicentre randomised controlled trial (RCT) of adults with T2D using ≥0.2 units/kg/day of insulin and elevated glycated haemoglobin (HbA1c) ≥64 mmol/mol (8.0%). Following a 2-week blinded CGM run-in phase, participants were randomised to rtCGM or control (self-monitoring blood glucose [SMBG]). The primary outcome was time in the target glucose range (3.9-10 mmol/L; TIR) during weeks 10-12, with data collected by blinded rtCGM in the control group. Sixty-seven participants entered the RCT phase (54% Māori, 57% female), median age 53 (range 16-70 years), HbA1c 85 (IQR 74, 94) mmol/mol (9.9 [IQR 8.9, 10.8]%), body mass index (36.7 ± 7.7 kg/m2). Mean (±SD) TIR increased from 37 (24)% to 53 (24)% [Δ 13%; 95% CI 4.2 to 22; P = 0.007] in the rtCGM group but did not change in the SMBG group [45 (21)% to 45 (25)%, Δ 2.5%, 95% CI -6.1 to 11, P = 0.84]. Baseline-adjusted between-group difference in TIR was 10.4% [95% CI -0.9 to 21.7; P = 0.070]. Mean HbA1c (±SD) decreased in both groups from 85 (18) mmol/mol (10.0 [1.7]%) to 64 (16) mmol/mol (8.0 [1.4]%) in the rtCGM arm and from 81 (12) mmol/mol (9.6 [1.1]%) to 65 (13) mmol/mol (8.1 [1.2]%) in the SMBG arm (P < 0.001 for both). There were no severe hypoglycaemic or ketoacidosis events in either group. Real-time CGM use in a supportive treat-to-target model of care likely improves glycaemia in a population with insulin-treated T2D and elevated HbA1c.

Glycemic Variability and the Thickness of Retinal Layers in Cystic Fibrosis Patients with and without Cystic Fibrosis Related Diabetes

Purpose Patients with cystic fibrosis (CF) are at risk to develop CF related diabetes (CFRD) and subsequently even diabetic neuro- and/or vasculopathy. We sought to determine if there are typical signs of diabetes-related retinal alterations present in CF patients with preserved and impaired glycemic control. Methods During routine annual examination CF patients were offered an additional 7-day period of real time continuous glucose monitoring (rtCGM) and an ophthalmological examination including retinal optical coherence tomography (OCT). Patients were categorized according to the glycemic control, i.e. the results of an oral glucose tolerance test (OGTT) and rtCGM were taken into consideration. OCT data was analyzed by our previously published visual analysis software generating dedicated and spatially resolved deviation maps for visualization and quantification of differences in total retinal thickness and thickness of retinal nerve fiber layer (RNFL) as well as ganglion cell layer (GCL) in comparison to age-matched healthy controls and patients with either type 1 or type 2 diabetes mellitus. Results Results of the rtCGM and/or OGTT enabled discrimination between patients with normal glycemic control (CFNG; n = 6), with abnormal glycemic control (CFAG; n = 6) and overt CFRD (n = 4). OCT data indicates gradually increasing retinal thinning in all 3 groups, depending on the degree of glucose metabolism disorder compared to healthy controls. At the foveal region total retinal thickness and GCL thickness were significantly thinner in CFRD patients compared to CFNG patients (total retinal thickness: 260.4 µm (239.3–270.8) vs. 275.4 µm (254.3–289.5); GCL: 11.82 µm (11.16–15.25) vs. 17.30 µm (13.95–19.82); each p < 0.05). Conclusion Although we investigated a rather small number of patients, we obtained evidence that intraretinal neurodegenerative changes occur in each of our subgroups (CFNG, CFAG, CFRD). Beyond this, our results favor the detrimental role of additional diabetes, as the deviations from healthy controls were most pronounced in the CFRD group and are similar to those seen in patients suffering from type 1 or type 2 diabetes.

Micro-3D printed Concanavalin A hydrogel based photonic devices for high-sensitivity glucose sensing

Concanavalin A (Con A)-based hydrogels have been widely studied in the field of glucose detection as Con A can selectively bond to glucose molecules. Many sensors have been proposed for detecting glucose using fluorescence or optical methods. However, these sensors suffer from limited sensitivity and fabrication issues. In this study, a label-free optical-fiber long-period grating-based glucose sensor is proposed. Con A-based UV-curable hydrogel was used as the sensing material, which can be rapidly prototyped using the micro-3D printing technique to realize microscale structures. Polymerized hydrogel grating structures patterned onto the fiber surface can periodically modulate the refractive index of the fiber modes affecting the resonant spectrum of the device. The structures swelled upon the addition of a glucose solution, which caused a wavelength shift in the transmission spectrum. The experiments showed that glucose-induced swelling/deswelling was reversible, and the wavelength versus glucose concentration was linear with a response sensitivity of 0.206 nm/mM over a wide range of 0–25 mM with high linearity (R2 = 0.998). The device works well at room temperature and has a short response time. It has significant potential for use in real time continuous glucose monitoring.

Glycaemic control and novel technology management strategies in pregestational diabetes mellitus.

Pregestational diabetes (PGDM) is an increasingly common and complex condition that infers risk to both mother and infant. To prevent serious morbidity, strict glycaemic control is essential. The aim of this review is to review the glucose sensing and insulin delivering technologies currently available for women with PGDM. We reviewed online databases for articles relating to technology use in pregnancy using a combination of keywords and MeSH headings. Relevant articles are included below. A number of technological advancements have improved care and outcomes for women with PGDM. Real time continuous glucose monitoring (rtCGM) offers clear advantages in terms of infants size and neonatal intensive care unit admissions; and further benefits are seen when combined with continuous subcutaneous insulin delivery (insulin pump) and algorithms which continuously adjust insulin levels to glucose targets (hybrid closed loop). Other advancements including flash or intermittent scanning CGM (isCGM) and stand-alone insulin pumps do not confer as many advantages for women and their infants, however they are increasingly used outside of pregnancy and many women enter pregnancy already using these devices. This article offers a discussion of the most commonly used technologies in pregnancy and evaluates their current and future roles.

Real-time continuous glucose monitoring improves glycemic control and reduces hypoglycemia: Real-world data

AimTo study the effect of real time continuous glucose monitor (RT-CGM) use on glycemic parameters in patients with diabetes mellitus (DM) in real world practice. MethodsWe retrospectively studied 91 adult subjects with DM who had been using Dexcom™ RT-CGM. Two consecutive hemoglobin A1c (HbA1c), both prior to and after at least 3 months of RT-CGM initiation, were collected. A total of 31 subjects completed a 5–14 day user blinded CGM using a Freestyle Libre™ prior to RT-CGM initiation. The first two week period following at least 3 months use of RT-CGM was analyzed for CGM metrics. ResultsA total of 51.6 % of subjects had T1DM, 34.1 % used continuous subcutaneous insulin infusion (CSII), and 62.6 % had DM for > 10 years. Both HbA1c obtained following RT-CGM initiation decreased significantly compared to baseline (8.11 + 1.47% vs 7.69 + 1.25 %; P = 0.002 & 8.16 + 1.51 % vs 7.62 + 1.06 %; P = 0.001). Subjects with baseline HbA1c > 7.0 % showed even more robust reduction in both HbA1c after RT-CGM initiation (8.74 + 1.24 % vs 7.99 + 1.22 %; P = 0.000 & 8.74 + 1.32 % vs 7.85 + 1.07 %; P = 0.001). On comparison of CGM metrics, there was a significant reduction in time spent in hypoglycemia (sugars < 70 mg/dl) including severe hypoglycemia (sugars < 54 mg/dl) after initiation of the RT-CGM (9.16 + 8.68 % vs 1.29 + 2.21 %; P = <0.001 & 4.58 + 5.43 % vs 0.28 + 0.58 %; P = <0.001). CoV of glucose was also decreased significantly (39.61 + 9.36 % vs 31.06 + 6.74 %; P = <0.001) with RT- CGM use. ConclusionRT-CGM use for at least 3 months in patients with DM results in meaningful HbA1c reductions with stable glycemic control without increasing the risk of hypoglycemia.

Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study

Adults with type 1 diabetes who are treated with multiple daily injections of insulin plus intermittently scanned continuous glucose monitoring (isCGM) can have suboptimal glucose control. We aimed to assess the efficacy of an advanced hybrid closed loop (AHCL) system compared with such therapy in this population. The Advanced Hybrid Closed Loop Study in Adult Population with Type 1 Diabetes (ADAPT) trial is a prospective, multicentre, open-label, randomised controlled trial that involved 14 centres in three European countries (France, Germany, and the UK). We enrolled patients who were at least 18 years of age, had a type 1 diabetes duration of at least 2 years, HbA1c of at least 8% (64 mmol/mol), and were using multiple daily injections of insulin plus isCGM (cohort A) or real time continuous glucose monitoring (cohort B) for at least 3 months. Here, only results for cohort A are reported. Participants were randomly allocated 1:1 to AHCL therapy or continuation of multiple daily injections of insulin plus continuous glucose monitoring for 6 months with an investigator-blinded block randomisation procedure. Participants and treating clinicians could not be masked to the arm assignment. The primary endpoint was the between-group difference in mean HbA1c change from baseline to 6 months in the intention-to-treat population using AHCL therapy and those using multiple daily injections of insulin plus isCGM. The primary endpoint was analysed using a repeated measures random-effects model with the study arm and period as factors. Safety endpoints included the number of device deficiencies, severe hypoglycaemic events, diabetic ketoacidosis, and serious adverse events. This study is registered with ClinicalTrials.gov, NCT04235504. Between July 13, 2020, and March 12, 2021, 105 people were screened and 82 randomly assigned to treatment (41 in each arm). At 6 months, mean HbA1c had decreased by 1·54% (SD 0·73), from 9·00% to 7·32% in the AHCL group and 0·20% (0·80) in the multiple daily injections of insulin plus isCGM from 9·07% to 8·91% (model-based difference -1·42%, 95% CI -1·74 to -1·10; p<0·0001). No diabetic ketoacidosis, severe hypoglycaemia, or serious adverse events related to study devices occurred in either group; two severe hypoglycaemic events occurred in the run-in phase. 15 device-related non-serious adverse events occurred in the AHCL group, compared with three in the multiple daily injections of insulin plus isCGM group. Two serious adverse events occurred (one in each group), these were breast cancer (in one patient in the AHCL group) and intravitreous haemorrhage (in one patient in the multiple daily injections of insulin plus isCGM group). In people with type 1 diabetes using multiple daily injections of insulin plus isCGM and with HbA1c of at least 8%, the use of AHCL confers benefits in terms of glycaemic control beyond those that can be achieved with multiple daily injections of insulin plus isCGM. These data support wider access to AHCL in people with type 1 diabetes not at target glucose levels. Medtronic International Trading Sàrl.

Accuracy of Real Time Continuous Glucose Monitoring during Different Liquid Solution Challenges in Healthy Adults: A Randomized Controlled Cross-Over Trial.

Continuous glucose monitoring (CGM) represents an integral of modern diabetes management, however, there is still a lack of sensor performance data when rapidly consuming different liquids and thus changing total body water. 18 healthy adults (ten females, age: 23.1 ± 1.8 years, BMI 22.2 ± 2.1 kg·m−2) performed four trial visits consisting of oral ingestion (12 mL per kg body mass) of either a 0.9% sodium chloride, 5% glucose or Ringer’s solution and a control visit, in which no liquid was administered (control). Sensor glucose levels (Dexcom G6, Dexcom Inc., San Diego, CA, USA) were obtained at rest and in 10-min intervals for a period of 120 min after solution consumption and compared against reference capillary blood glucose measurements. The overall MedARD [IQR] was 7.1% [3.3–10.8]; during control 5.9% [2.7–10.8], sodium chloride 5.0% [2.7–10.2], 5% glucose 11.0% [5.3–21.6] and Ringer’s 7.5% [3.1–13.2] (p < 0.0001). The overall bias [95% LoA] was 4.3 mg·dL−1 [−19 to 28]; during control 3.9 mg·dL−1 [−11 to 18], sodium chloride 4.8 mg·dL−1 [−9 to 19], 5% glucose 3.6 mg·dL−1 [−33 to 41] and Ringer’s solution 4.9 mg·dL−1 [−13 to 23]. The Dexcom G6 CGM system detects glucose with very good accuracy during liquid solution challenges in normoglycemic individuals, however, our data suggest that in people without diabetes, sensor performance is influenced by different solutions.

Development and Psychometric Assessment of a Manufacturer Independent Knowledge Questionnaire on Real Time Continuous Glucose Monitoring for insulin-treated People with Diabetes

Abstract Background To benefit from real-time continuous glucose monitoring (rtCGM), users need practical skills and in-depth knowledge to analyze the glucose data appropriately and adapt insulin therapy accordingly. To assess the user’s knowledge about rtCGM, a psychometric knowledge test was developed and evaluated. Method Experts on the use of rtCGM systems defined central knowledge contents in a Delphi process and developed a knowledge test comprising 40 multiple-choice items. For test-statistical review, people with insulin-treated diabetes and members of diabetes teams answered the knowledge test. Results The 122 diabetes team members (age 46 (11) years; mean (SD)) and the 111 people with insulin-treated diabetes (age 42 (14) years, diabetes duration 20 (14) years, users of insulin pumps 64 %, previous usage of rtCGM 38 %, HbA1c 8.0 % [95 % CI 7.7–8.3] (64 mmol/mol [60–67]) had different levels of experiences using rtCGM systems. The internal consistency (Cronbach’s alpha) of the knowledge test was 0.92 for the whole sample, for people with diabetes 0.94, and for diabetes team members 0.84. Item difficulty ranged between 0.12 and 0.88 in people with diabetes and between 0.27 and 0.97 among diabetes team members. On average, people with diabetes answered 24.1 (9.9) items correctly, diabetes team members 29.2 (5.2) (p &lt; 0.001); people with diabetes and previous rtCGM-experience had a higher knowledge compared to people without previous experience (29.2 (6.2) vs. 21.0 (10.4) (p = 0.001)). The quality of glucose control (measured by HbA1c) of the people with diabetes was significantly associated with the sum-score of the questionnaire (rho = –0.48, p &lt; 0.001). Conclusion The “rtCGM-Profi-Check” knowledge test provides high internal consistency, high selectivity, and content validity. It is suitable for objective, reliable, and valid assessment of the indispensable knowledge of people with diabetes to use different rtCGM systems successfully. The questionnaire is manufacturer-independent and is suitable to evaluate the needs and success of rtCGM education among persons with diabetes.

61-LB: Continuous Glucose Monitoring (CGM) in ICU Patients during COVID-19: A Pilot Study

Objective: During the COVID 19 pandemic, the FDA approved emergency authorization of Real Time Continuous Glucose Monitoring (RT-CGM) for inpatient use. The objective of this study was to evaluate the safety of RT-CGM use. Methods: Blood Glucose (BG) data were collected from the electronic medical record and the Dexcom system on 165 patients treated on DEXCOM CGM from June to December using a preapproved protocol. Retrospective chart review was performed on 60 patients on vasopressors and dialysis. Analysis included glycemic control, hypoglycemia rate, and correlation between finger stick (FS) and RT-CGM BG. Pearson's correlation coefficients (PCC) and MARD were calculated. Strong correlation was defined as a PCC value of > 0.7. Results: Of the > 300,000 BG readings from DEXCOM, 81 % were between 70-180 mg/dl;12 % between 180-250mg/dl;and 5% were > 250 mg/dl. The incidence of hypoglycemia was low, 0.8% values being between 55 - 69 mg/dL and 0.5% being < 55 mg/dL. Of the 2016 readings used for correlation, the PCC between FS and RT-CGM glucose was 0.838 with a MARD of 14%. PCC was 0.798 for patients on vasopressors and 0.79 for dialysis Patients. Conclusions: In this preliminary study, Dexcom CGM utilization was safe with a low incidence of hypoglycemia and good correlation to FS blood glucose. CGM utilization decreased the frequency of FS for most patients, and was well accepted by the clinical team.

Cost-effectiveness of real time continuous glucose monitoring to target glucose control in preterm infants

The optimal management of glucose levels in critical care remains an area for research due to the problems of balancing the risks of hyperglycemia versus hypoglycemia. This paper reports the first economic evaluation of real time continuous glucose monitoring to guide the clinical management of preterm infants, based on evidence from the REACT trial. Bivariate regression of costs (£, 2016-17 prices) and cases of adequate glucose control, with multiple imputation of missing data, was conducted. When the economic evaluation was restricted to the first week of life, real time continuous glucose monitoring was associated with increased costs and a statistically significant increase in adequate glucose control. When the assessment was performed over a time horizon extending to 36 weeks’ corrected gestational age, real time CGM was dominant in health economic terms, i.e. associated with lower costs and better outcomes. These results largely remained robust to a range of sensitivity analyses and sub-group analyses designed to address uncertainty and heterogeneity surrounding the cost-effectiveness outcomes. This study suggests that the use of real time continuous glucose monitoring in preterm infants is associated with a high probability of cost-effectiveness.

Adjustment of Insulin Therapy: New Insights from Continuous Glucose Monitoring

Diabetes management technology has advanced dramatically in recent decades, particularly real time continuous glucose monitoring (rtCGM) systems. A recent meta-analysis showed that rtCGM can reduce HbA1c by around 0.3% compared to standard care, and prevent hypoglycemia. In the CGM era, new treatment targets such as time in range should be considered in conjunction with HbA1c. One study using rtCGM demonstrated an increase of time in range compared to conventional treatment. rtCGM presents current glucose concentration data, as well as the direction and rate of change in glucose level every 1 to 5 minutes. This information enables development of new insulin dosing algorithms. This fine-tuning of insulin therapy should be based on healthy eating behavior. Furthermore, as the patient is the center of diabetes management patient education is needed regarding how this new technology can improve glucose management. This manuscript summarizes the utility of rtCGM for insulin adjustment. Keywords: Ambulatory glucose profile; Continuous glucose monitoring system; Education; Insulin therapy

Enabling equality of employment with insulin treated diabetes in safety‐critical occupations

Enabling equality of employment with insulin treated diabetes in safety‐critical occupations

852-P: Is Real-Time CGM Superior to Flash Glucose Monitoring? Results of the Type 1 Diabetes CORRIDA Randomized Control Trial

Background: The trial aim was to compare the efficacy of real-time and intermittently-scanned continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control. Methods: In this randomized study, adults with T1D and normal hypoglycemia awareness (GOLD score Results: Sixty adults with T1D (age 38±13 years, HbA1c 7.8±1.1% [62±12 mmol/mol]) were randomized to rtCGM (n=30) or isCGM (n=30). All participants completed the study. Time in hypoglycemia ( Conclusion: rtCGM was superior to isCGM in preventing hypoglycemia and improving time in range in T1D adults with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management. Disclosure J. Soupal: Advisory Panel; Self; Abbott. Consultant; Self; Medtronic, Roche Diabetes Care. Speaker’s Bureau; Self; Dexcom, Inc. A. Haskova: None. G. Grunberger: Research Support; Self; Medtronic. L. Petruzelkova: None. C. Parkin: Consultant; Self; Abbott, CeQur Corporation, Dexcom, Inc., DreaMed Diabetes, Novo Nordisk Inc., Onduo, Roche Diabetes Care, Valeritas, Inc. J. Skrha: Advisory Panel; Self; Boehringer Ingelheim International GmbH. Speaker’s Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp. L. Radovnicka: None. E. Horova: None. M. Prazny: Speaker’s Bureau; Self; Novartis Pharmaceuticals Corporation, Roche Diabetes Care. Other Relationship; Self; Abbott, Boehringer Ingelheim International GmbH, Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi, Teva Pharmaceutical Industries Ltd. Funding 15-26705A (Program RVO-VFN00064165)

1390-P: Fetal Growth Acceleration Is Still Common in Well-Controlled Pregnant Women with Type 1 Diabetes Using Real-Time Glucose Monitoring

Introduction: Glycemic control has a major effect on fetal growth in women with type 1 diabetes mellitus (DM1), worse control leading to increased growth (large for gestational age (LGA) or very large for gestational age (VLGA) fetus). Currently, we aim at strict control (at least HbA1c ≤ 48 mmol/mol) before and during pregnancy. Real Time Continuous Glucose Monitoring (RTCGM) offers new ways to achieve this. We performed a retrospective chart review of pregnancy outcomes in DM1 to assess outcome and CGM-data in well-controlled women with DM1. Methods: Forty-eight pregnancies in 25 women were identified between 2016-2019; 19 women with a singleton pregnancy met the inclusion criterion of HbA1c ≤ 48 mmol/mol in 1st and 3rd trimester; 8 women had insufficient CGM-data.; CGM could be analysed in 11 women. LGA was defined as fetal weight &amp;gt; 90th and VLGA &amp;gt; 97.7th percentile. CGM-data were studied during 4 periods: 4-8 weeks gestation, 18-22 weeks, 30-34 weeks and last 8 days before delivery. Target range 3.5-7.8 mmol/L. Time in range (TIR), time below range (TBR) and time above range (TAR) were calculated. Results: In the 19 women with adequate control, LGA (LGA and VLGA) in 36.8%; simple LGA 15.7%, VLGA 21.1%. There were no congenital malformations. Women with VLGA child were significantly older (p&amp;lt;0.03), had higher BMI (p&amp;lt;0.02) and longer duration of DM1 (p&amp;lt;0.02). In women with normal growth fetus, LGA or VLGA, Time In Range (TIR) was 64.1%, 63.6% and 58.5%; Time Above Range (TAR): 24.4, 34.4 and 39.6%; Time Below Range: 4.0, 2.2 and 2.1%. Conclusion: Our data show that current implementation of advanced technology was associated with mean TIR below recommended level of &amp;gt;70% and TAR above recommended level (&amp;lt;25%). Prevalence of LGA and VLGA was still increased. Adaptation of care and counselling re needed for improvement in outcome with technology. Disclosure H.W. de Valk: None. L. Oosterwijk: None. K. Kaasjager: None.

Real time continuous glucose monitoring in neonatal intensive care

Hypoglycaemia and hyperglycaemia are common in infants requiring intensive care and are associated with worse clinical outcomes. However, glucose levels are taken infrequently, and there remains controversy regarding optimal management. In adults and children continuous glucose monitoring (CGM) is now established as an important adjunct to caring for patients at risk from dysglycaemia. This technology is also increasingly providing insights into glucose regulation in the newborn, demonstrating significant periods of clinically silent hypoglycaemia and hyperglycaemia. This baseline data will be important to allow the significance of glucose dysregulation on long-term outcomes to be assessed. Small studies have also shown the potential for CGM to safely support targeting of glucose control in preterm infants, and a large multicentre trial is ongoing. Current technology is not specifically designed for use in NICU, but with rapid technological developments, CGM holds promise for the future care of babies in NICU.

378-P: Human Voice Is Modulated by Hypoglycemia and Hyperglycemia in Type 1 Diabetes

Anecdotal evidence suggests that high pitched voice may be a clinical symptom of hypoglycemia. We conducted a pioneer study aiming at assessing voice variables during hypoglycemia and hyperglycemia. We recruited 10 non-smoking individuals with type 1 diabetes (4 women, 6 men; mean [±SD] age 40.2±10.4 years, diabetes duration 21.4±9.9 years, HbA1c 8.0±1.8%) who were using real time continuous glucose monitoring system (rt-CGM, Guardian Connect, Medtronic) for mean 5.2±0.6 days in controlled hospital setting. At regular intervals during normoglycemia and additionally at blood glucose &amp;lt;70 mg/dl or &amp;gt;200 mg/dl each patient was instructed to record with a professional voice recorder (LS-14, Olympus) a standardized sentence and the sound of vowel ‘a’ for 3 seconds. The voice samples (n=177) were analyzed against CGMS data with the DiagnoScope software (DiagNova, Wroclaw, Poland). Number of fundamental PERiods (PER), time of fundamental PERiods (PERTime), fundamental frequency (F0), energy (E), amplitude of fundamental frequency (AF0), indicator of voiced/phonation probability (Voiced), simple voice quality (SimpleQ), relative average perturbation (RAP), shimmer (Shimm), amplitude perturbation quotient (APQ), four formant frequencies (F1-F4), harmonic perturbation quotients (HPQ), residual to harmonic ratio (R2H), unharmonic to harmonic ratios (U2H), subharmonic to harmonic ratio (S2H), noise to harmonics ratio (NHR), 1st to 4th harmonic to all energy ratio (Fx1-Fx4) were analyzed. In women during hypoglycemia E, AF0, Voiced, F1, F4, R2H, Fx3, Fx4, while in hyperglycemia - RAP and F2 were significantly altered when compared to normoglycemia. In men in hypoglycemia the differences were found in PER, PERTime, Voiced, SimpleQ, Shimm, APQ, F2, U2H, S2H, Fx2, NHR, while in hyperglycemia - PERTime, F1, HPQ, U2H, Fx2 (all p&amp;lt;0.05). We report for the first time that hypoglycemia and hyperglycemia modulate human voice. This phenomenon may offer potential for early detection and prevention of hypoglycemia. Disclosure L. Czupryniak: None. E. Sielska-Badurek: None. A. Niebisz: None. M. Sobol: None. M. Kmiecik: None. K. Jedra: None. E. Szymanska-Garbacz: None. K. Niemczyk: None. Funding Polish Ministry of Science and Higher Education

Comprehensive Analysis of the Real Lifestyles of T1D Patients for the Purpose of Designing a Personalized Counselor for Prandial Insulin Dosing.

Post-prandial hyperglycemia is still a challenging issue in intensified insulin therapy. Data of 35 T1D patients during a four-week period were analyzed: RT-CGM (real time continuous glucose monitoring) record, insulin doses, diet (including meal photos), energy expenditure, and other relevant conditions. Patients made significant errors in carbohydrate counting (in 56% of cooked and 44% of noncooked meals), which resulted in inadequate insulin doses. Subsequently, a mobile application was programmed to provide individualized advice on prandial insulin dose. When using the application, a patient chooses only the type of categorized situation (e.g., meals with other relevant data) without carbohydrates counting. The application significantly improved postprandial glycemia as normoglycemia was reached in 95/105 testing sessions. Other important findings of the study include: A high intake of saturated fat (median: 162% of recommended intake); a low intake of fiber and vitamin C (median: 42% and 37%, respectively, of recommended intake); an increase in overweight/obesity status (according to body fat measurement), especially in women (median of body fat: 30%); and low physical activity (in 16/35 patients). The proposed individualized approach without carbohydrate counting may help reach postprandial normoglycemia but it is necessary to pay attention to the lifestyle habits of T1D patients too.

Comparison of flash glucose monitoring with real time continuous glucose monitoring in children and adolescents with type 1 diabetes treated with continuous subcutaneous insulin infusion

AimsIn 2016 intermittently scanned continuous glucose monitoring (isCGM) became the first reimbursed CGM system in Belgium. Many children with type 1 diabetes (T1D) treated with multiple daily injections as well as with continuous subcutaneous insulin infusion (CSII) switched from self-monitoring of blood glucose to isCGM to monitor their treatment. In 2017 the Enlite® real-time CGM (rtCGM) system was reimbursed enabling its use with the Minimed® 640G insulin pump with integrated SmartGuard technology. In this study we compared the metabolic control during CSII with isCGM with that during rtCGM. Patient’s satisfaction and side effects of the rtCGM system were also evaluated. Methods20 children with T1D, aged 5–16 years, were included. Metabolic control during the last month of isCGM use was compared to that during the 3rd and 6th month of rtCGM. ResultsThree patients stopped early rtCGM mainly due to calibration burden. The HbA1c level and the mean glucose value in the other patients did not change after switching to the rtCGM system. Glucose variability was smaller (46.2% vs 38.4% and 36.4%, p = 0.000). Time in hypoglycemia (<70 mg/dl) was lower (7.4% vs 1.6% and 1.5%, p = 0.000). The main patient inconvenience was the sensor calibration. ConclusionsOur data show that during Enlite® rtCGM with the Minimed® 640G pump system glucose variability was smaller and the patients spent less time in hypoglycemia than during isCGM. The need for timely calibrations is considered as the main drawback of the system.

The use of real time continuous glucose monitoring or flash glucose monitoring in the management of diabetes: A consensus view of Italian diabetes experts using the Delphi method

Until recently, in Italy, the use of continuous glucose monitoring (CGM) systems has been limited, but is now rapidly increasing, including the so-called real-time CGM (rtCGM) and the intermittently viewed CGM (iCGM), also called Flash Glucose Monitoring (FGM). These technologies overcome many of the limitations of self-monitoring of blood glucose (SMBG) by fingerprick and allow to go beyond HbA1c to check glucose control in diabetes. However, standardized protocols for applying and interpreting rtCGM and FGM data are lacking. In this paper, we delineate a consensus amongst Italian diabetes physicians on the attributes of rtCGM and FGM technologies, and introduce a consistent approach for their use by Italian healthcare professionals. Most experts consider rtCGM and FGM as two separate categories of interstitial subcutaneous fluid (ISF) sensing technologies, and see them as superior to SMBG. Furthermore, there is strong consensus that rtCGM and FGM reduce hypoglycemia risk, increase the amount of time in the target glucose range and augment treatment satisfaction. However, there is still no agreement on the indication of the FGM for subjects who suffer asymptomatic hypoglycemia. Consensus on the role of education in initiating and optimizing use of rtCGM/FGM and about the interpretation of glucose trends was near unanimous, whereas no consensus was reached on the statement that there are no disadvantages/risks of rtCGM/FGM. Some issues remain in rtCGM/FGM management: a) risk of excessive correction of high or low glucose; b) risk of alert fatigue leading to alert silencing or rtCGM termination; c) allergic reaction to the adhesive keeping rtCGM or FGM sensors in place. The panel almost unanimously agreed that sensor accuracy depends on multiple variables, that alarm setting should be individualized, and that global glycemic profile represent an useful tool in interpreting glucose data. More clinical studies and a wider use of these devices will increase the efficacy and effectiveness of continuous glucose monitoring in Italy.