Number Of Hypoglycemic Episodes Research Articles

Association of Fetal Catecholamines With Neonatal Hypoglycemia

Perinatal stress and fetal growth restriction increase the risk of neonatal hypoglycemia. The underlying pathomechanism is poorly understood. In a sheep model, elevated catecholamine concentrations were found to suppress intrauterine insulin secretion, followed by hyperresponsive insulin secretion once the adrenergic stimulus subsided. To determine whether neonates with risk factors for hypoglycemia have higher catecholamine concentrations in umbilical cord blood (UCB) and/or amniotic fluid (AF) and whether catecholamines are correlated with postnatal glycemia. In a prospective cohort study of 328 neonates at a tertiary perinatal center from September 2020 through May 2022 in which AF and UCB were collected immediately during and after delivery, catecholamines and metanephrines were analyzed using liquid chromatography with tandem mass spectrometry. Participants received postnatal blood glucose (BG) screenings. Risk factor for neonatal hypoglycemia. Comparison of catecholamine and metanephrine concentrations between at-risk neonates and control participants, and correlation of concentrations of catecholamines and metanephrines with the number and severity of postnatal hypoglycemic episodes. In this study of 328 neonates (234 in the risk group: median [IQR] gestational age, 270 [261-277] days; and 94 in the control group: median [IQR] gestational age, 273 [270-278] days), growth-restricted neonates showed increased UCB median (IQR) concentrations of norepinephrine (21.10 [9.15-42.33] vs 10.88 [5.78-18.03] nmol/L; P < .001), metanephrine (0.37 [0.13-1.36] vs 0.12 [0.08-0.28] nmol/L; P < .001), and 3-methoxytyramine (0.149 [0.098-0.208] vs 0.091 [0.063-0.149] nmol/L; P = .001). Neonates with perinatal stress had increased UCB median (IQR) concentrations of norepinephrine (22.55 [8.99-131.66] vs 10.88 [5.78-18.03] nmol/L; P = .001), normetanephrine (1.75 [1.16-4.93] vs 1.25 [0.86-2.56] nmol/L; P = .004), and 3-methoxytyramine (0.120 [0.085-0.228] vs 0.091 [0.063-0.149] nmol/L; P = .008) (P < .0083 was considered statistically significant). Concentrations of UCB norepinephrine, metanephrine, and 3-methoxytyramine were negatively correlated with AF C-peptide concentration (rs = -0.212, P = .005; rs = -0.182, P = .016; and rs = -0.183, P = .016, respectively [P < .017 was considered statistically significant]). Concentrations of UCB norepinephrine, metanephrine, and 3-methoxytyramine were positively correlated with the number of hypoglycemic episodes (BG concentration of 30-45 mg/dL) (rs = 0.146, P = .01; rs = 0.151, P = .009; and rs = 0.180, P = .002, respectively). Concentrations of UCB metanephrine and 3-methoxytyramine were negatively correlated with the lowest measured BG concentration (rs = -0.149, P = .01; and rs = -0.153, P = .008, respectively). Neonates at risk for hypoglycemia displayed increased catecholamine and metanephrine concentrations that were correlated with postnatal hypoglycemic episodes and lower BG levels; these results are consistent with findings in a sheep model that fetal catecholamines are associated with neonatal β-cell physiology and that perinatal stress or growth restriction is associated with subsequent neonatal hyperinsulinemic hypoglycemia. Improving the pathomechanistic understanding of neonatal hypoglycemia may help to guide management of newborns at risk for hypoglycemia.

The impact of the implementation of computerized insulin order sets for the control of hyperglycemia in hospitalized cardiac patients.

Glycemic control is crucial in managing hospitalized patients with type II diabetes (T2DM), and it presents as a clinical challenge in the cardiac population. Therefore, we aimed to evaluate the impact of computerized insulin order sets in T2DM hospitalized cardiac patients. A quasi-experimental, pre- and post-study design. We included T2DM patients who were hospitalized for at least 3 days. Patients undergoing cardiac surgery were excluded. The primary endpoint was the mean difference in random blood glucose level (BGL) before and after the implementation of insulin order sets. While the secondary endpoints were to compare the median differences in fasting BGLs and the number of hyperglycemic and hypoglycemic episodes during the first 7 days. The study consisted of three phases: pre-implementation, intervention and post-phase. In the intervention phase, insulin order sets were integrated into the electronic prescribing system, and education was provided to the cardiology department. The post-phase included the patient's post-implementations. A total of 194 patients were enrolled during the study period. The mean random BGL was 11.17 mmol/L, 95% CI, 10.6-11.7 in the pre-phase and 9.5 mmol/L, 95% CI, 9-1 -9.9 mmol/L in the post-phase (P < 0.001). The median fasting BGL was 9.2 mmol/L (7.4-11.8, IQR) in the pre-phase and 8.5 mmol/L (6.6-10.3, IQR) in the post-phase (P = 0.027). The number of hypoglycemic episodes was 24 in pre-phase and 33 in post-phase (P = 0.13). The use of computerized insulin order sets was associated with potential improvements in random and fasting glycemic control without increasing the risk of hyperglycemia or hypoglycemia.

Determinants of Self-monitoring of Blood Glucose in Iranian Children and Adolescents with Type 1 Diabetes.

Type 1 diabetes mellitus (T1DM) is a prevalent chronic disease among children and adolescents, necessitating effective self-monitoring of blood glucose (SMBG) levels. Understanding the determinants and factors influencing SMBG behavior is crucial for optimizing diabetes management in this population. This study aimed to investigate the frequency of SMBG and identify the determinants influencing factors in children and adolescents with T1DM. This cross-sectional study was conducted in Tehran, Iran, and included 275 participants selected through simple random sampling from the Gabric Diabetes Education Association. The inclusion criteria comprised children and adolescents aged 3 - 18 years diagnosed with T1DM for at least 6 months who were using analog or neutral protamine Hagedorn (NPH) and regular insulin subcutaneously. Patients using insulin pumps were excluded. Data collection involved an online questionnaire covering demographic information (e.g., age, gender, educational status, and parental occupations) as well as clinical information (number of hypoglycemic episodes, hemoglobin A1C (HbA1C) levels, diabetes duration, insulin regimen, diabetes complications, glucose monitoring practices, hospitalizations, and behavioral characteristics). Statistical analyses, including descriptive statistics, correlation tests, and Poisson regressions, were performed using SPSS software (version 21). A significance level of P-value < 0.05 was considered statistically significant. The participants had a mean age of 10.00 ± 3.77 years, with 54.2% being males. Most of the participants (87.3%) were schoolchildren, and the mean age of diagnosis was 6.56 ± 3.73 years, with a mean duration of 44.72 ± 36.32 months. Anthropometric investigations revealed mean height, weight, and body mass index (BMI) values of 136.69 ± 21.11 cm, 37.45 ± 15.51 kg, and 18.31 ± 3.55 kg/m2, respectively. The majority of participants (93.5%) used insulin pens, and the mean daily insulin dosage was 35.34 ± 22.20 IU. Parents reported consistent glucose level monitoring in 64.7% of cases. The mean HbA1c level was 7.91 ± 1.58%. Factors such as the price and availability of glucometer strips influenced glucose level monitoring. In univariate analysis, only age and HbA1C levels showed a negative correlation; however, parents' consistent checking showed a positive correlation with the frequency of daily, weekly, or monthly glucose checking. This study underscores the significance of SMBG in children and adolescents with T1DM. The findings emphasize the critical role of price and availability of glucometers and strips in achieving standard care for T1DM patients.

Open source automated insulin delivery systems: experience of russian patients

Open source closed loop automated insulin delivery (CL-AID) systems are increasingly used in the treatment of diabetes. Not being officially approved, such systems are used by patients on their own initiative. Accordingly, the medical community has very little information about the treatment satisfaction and needs of patients that use these systems. We conducted an anonymous internet survey of Russian users of open source CL-AID systems. Ninety-five respondents reported using AndroidAPS (60%), FreeAPS X (16.6%), Loop (10.5%), FreeAPS (5.3%), OpenAPS (3.2%), and Omnia (2.1%). The duration of use of the systems ranged from 0.1 to 6 years (median 2.1 years). The mean HbA1c in users was 6.1% v.s. 7.3% on previous therapy. Most respondents reported an increase in Time in Range (88%), a decrease in the number of hypoglycemic episodes (73%), an improvement in the sleep quality (76%), general well-being (73%), social adaptation (56%) and self-confidence (69%), as well as a decrease in stress levels (56%) after switching to the systems. Ninety (94%) survey participants reported increase in the treatment satisfaction. The majority of respondents (68%) consider themselves advanced gadget users. However, 79% of them had technical difficulties when setting up the system for the first time, 46% had difficulty understanding the settings of the algorithm / program, and 35% spent a lot of effort studying the system. Support from the attending physician was reported by 27% of respondents, 35% noted the neutral attitude to the use of the system, and in 18% of cases the doctor was not aware of its use. All respondents, with the exception of two who found it difficult to answer, plan to continue using the system. Thus, from the patient's point of view, open source CL-AID systems have a positive effect on glycemic control and quality of life. The medical community should pay more attention to the needs of patients using these systems in treatment.

The effect of the modified fat-protein unit algorithm compared with that of carbohydrate counting on postprandial glucose in adults with type-1 diabetes when consuming meals with differing macronutrient compositions: a randomized crossover trial

BackgroundThe optimization of glucose control in type-1 diabetes is challenged by postprandial glycemic variability. This study aimed to compare the postprandial glycemic effects of carbohydrate counting and the modified fat-protein unit (FPU) algorithms following meals with different protein and fat emphases in adults with type-1 diabetes.MethodsThirty adults with type-1 diabetes aged 18 to 45 years participated in a randomized crossover trial. In a random order, participants consumed four test meals with equivalent energy and different macronutrient emphases on four separate mornings. The modified FPU algorithms and carbohydrate counting were used to determine the insulin dose for the test meals. A continuous glucose monitoring system was used to measured postprandial glycemia.ResultsCompared with carbohydrate counting, the modified FPU algorithm significantly decreased the late postprandial mean glucose levels (p = 0.026) in high protein-fat meals. The number of hypoglycemia episodes was similar between insulin dosing algorithms for the high protein-fat meals; hypoglycemic events were considerably higher for the modified FPU in the normal protein-fat meal (p = 0.042).ConclusionsThe modified FPU algorithm may improve postprandial glycemic control after consuming high protein-fat meals in adults with type-1 diabetes but may result in increased hypoglycemia risk when used with a normal protein-fat meal.

Switching from Multiple Insulin Injections to a Fixed Combination of Degludec and Liraglutide in Patients with Type 2 Diabetes Mellitus: Results from the Simplify Study After 6Months.

This study aimed to evaluate the effectiveness and safety of switching from basal bolus insulin treatment (BBIT) to a fixed combination of insulin degludec and liraglutide (IDegLira) in patients with type 2 diabetes mellitus (T2DM) who had preserved insulin secretion but inadequate glucose control. The study also aimed to assess the feasibility of implementing this therapeutic approach in common clinical practice settings. This was a non-randomized, open-label, multicenter, prospective, single-arm study involving 234 patients with T2DM who were receiving BBIT. Inclusion criteria were duration of diabetes mellitus > 60months, stable total daily dose of insulin (TDDI) ranging from > 20 to < 70IU/day (approx. > 0.3 to < 0.7IU/kg body weight/day), C-peptide levels > 10% above the lower limit, HbA1c levels > 7% and < 10% (Diabetes Control and Complications Trial), and body mass index > 25kg/m2. The primary endpoints were changes in glycated hemoglobin (HbA1c) and body weight at week 28 after treatment switching. Secondary endpoints included changes in the 7-point glycemic profile, hypoglycemia frequency, blood pressure, blood lipids, liver enzymes, insulin dose, and a patient questionnaire focusing on treatment satisfaction, concerns and impact on daily activities. A subgroup of 55 patients underwent continuous glucose monitoring (CGM) with the evaluation of CGM-derived parameters, such as time in range (TIR), time above range (TAR), time below range (TBR), hypoglycemia, and glucose variability. A significant decrease in HbA1c (8.6% vs. 7.6%; p < 0.0001) and body weight (97.8 vs. 94.0kg; p < 0.0001) was observed at week 28 after treatment switching. Significant improvements were also seen in all measurements of the 7-point glycemic profile (p < 0.0001), reduction in the number of hypoglycemia episodes per patient, and the proportion of patients with at least one hypoglycemia event (p < 0.001). Furthermore, there was a significant decrease in daily insulin dose (55.6 vs. 32.7IU/day; p < 0.0001), as well as improvements in blood pressure, blood lipids, and liver enzymes (gamma glutamyl transferase and alanine aminotransferase). The subgroup of patients who underwent CGM showed a significant increase in TIR (57.9% vs. 69.0%; p < 0.01) and a decrease in TAR (40.1% vs. 28.8%; p < 0.01), while TBR, hypoglycemia (number of episodes per patient and proportion of patients), and glucose variability did not change significantly. The results of this study suggest that switching from BBIT to IDegLira in patients with T2DM and preserved insulin secretion can simplify treatment without compromising glycemic control. The switch to IDegLira was associated with significant improvements in various glucose control parameters, including HbA1c, glycemic profile, hypoglycemia, insulin doses, and CGM-derived parameters TIR and TAR. Additionally, it led to significant reductions in body weight, blood pressure, lipid profile, and liver enzyme levels. Switching to IDegLira may be considered a safe and beneficial approach in clinical practice settings, offering metabolic and individual advantages.

Management of Glycemia during Acute Aerobic and Resistance Training in Patients with Diabetes Type 1: A Croatian Pilot Study

(1) Background: The increased risk of developing hypoglycemia and worsening of glycemic stability during exercise is a major cause of concern for patients with type 1 diabetes mellitus (T1DM). (2) Aim: This pilot study aimed to assess glycemic stability and hypoglycemic episodes during and after aerobic versus resistance exercises using a flash glucose monitoring system in patients with T1DM. (3) Participants and Methods: We conducted a randomized crossover prospective study including 14 adult patients with T1DM. Patients were randomized according to the type of exercise (aerobic vs. resistance) with a recovery period of three days between a change of groups. Glucose stability and hypoglycemic episodes were evaluated during and 24 h after the exercise. Growth hormone (GH), cortisol, and lactate levels were determined at rest, 0, 30, and 60 min post-exercise period. (4) Results: The median age of patients was 53 years, with a median HbA1c of 7.1% and a duration of diabetes of 30 years. During both training sessions, there was a drop in glucose levels immediately after the exercise (0'), followed by an increase at 30' and 60', although the difference was not statistically significant. However, glucose levels significantly decreased from 60' to 24 h in the post-exercise period (p = 0.001) for both types of exercise. Glycemic stability was comparable prior to and after exercise for both training sessions. No differences in the number of hypoglycemic episodes, duration of hypoglycemia, and average glucose level in 24 h post-exercise period were observed between groups. Time to hypoglycemia onset was prolonged after the resistance as opposed to aerobic training (13 vs. 8 h, p = NS). There were no nocturnal hypoglycemic episodes (between 0 and 6 a.m.) after the resistance compared to aerobic exercise (4 vs. 0, p = NS). GH and cortisol responses were similar between the two sessions, while lactate levels were significantly more increased after resistance training. (5) Conclusion: Both exercise regimes induced similar blood glucose responses during and immediately following acute exercise.

Fear of hypoglycemia and associated factors in hospitalized patients with type 2 diabetes: a cross‑sectional study

The present cross-sectional survey was performed to assess the prevalence and factors associated with fear of hypoglycemia (FoH) in hospitalized patients with type 2 diabetes (T2D). Between July and December 2020, 494 patients with T2D were evaluated via structured questionnaires containing sociodemographic information, clinical information, and the Fear of Hypoglycemia-15 scale (FH-15). Patients were divided into the FoH and non-FoH groups according to the FH-15 score. Univariate and multivariate logistic regression analyses were performed to determine factors associated with FoH. Variables with P values < 0.1 in the univariate model were included in the multivariate model. In this study, the prevalence of FoH was 17.4% (86/494). 247 (50.0%) patients experienced hypoglycemic episodes in the past year, and 15 (3.0%) patients experienced severe hypoglycemic episodes in the past year. The mean age was 60.04 ± 11.71 years old, and female patients accounted for 39.9% of the sample. The item with the highest average FH-15 scores was: how often are you afraid of having hypoglycemia while alone? Multivariate logistic regression analysis indicated that living alone (OR 2.48; 95% CI 1.20–5.14; P = 0.015), number of hypoglycemic episodes in the past year (OR 1.06; 95% CI 1.03–1.10; P < 0.001), number of severe hypoglycemic episodes in the past year (OR 2.61; 95% CI 1.20–5.69; P = 0.016), and duration of insulin use (OR 1.06; 95% CI 1.02–1.10; P = 0.006) were associated with FoH. The prevalence of FoH in hospitalized patients with T2D was high. FoH was associated with living alone, number of hypoglycemic episodes in the past year, number of severe hypoglycemic episodes in the past year, and duration of insulin use. These findings can contribute to early decision-making for preventing, identifying, and improving FoH in patients with T2D. In the future, interventions aimed at reducing FoH to improve the harmful effects of FoH are necessary, such as increasing diabetes-related knowledge and skills, increasing social support, reducing psychological fear, and minimizing risks for hypoglycemic episodes.

Influence of resistant starch resulting from the cooling of rice on postprandial glycemia in type 1 diabetes

IntroductionCarbohydrates are one of the macronutrients which have the most substantial influence on glycemic response. The cooling of rice after cooking causes retrogradation of starch, which becomes a non-absorbable product in the human digestive tract.Aim of the studyThis study aimed to assess whether cooling of rice affects postprandial glycemia in subjects with type 1 diabetes.Materials and methodsThe study included 32 patients with type 1 diabetes. Each participant of the study consumed two standardized test meals consisting of long-grain white rice. One of the test meals was served immediately after preparation, and another was cooled for 24 h at 4 °C after preparation and reheated before being served. Postprandial glycemia was measured for 3 h using the FreeStyle Libre flash glucose monitoring system for each patient.ResultsAfter consumption of the test meal containing rice subjected to the cooling process when compared to fresh rice, a significantly lower value of maximum glycemia (11 vs. 9.9 mmol/L, p = 0.0056), maximum glycemic increase (2.7 vs. 3.9 mmol/L, p < 0.0001), areas under the glycemic curve (135 vs. 336 mmol/L * 180 min, p < 0.0001) and significantly shorter time to peak (35 vs. 45 min, p = 0.031) was observed. There was a significantly higher number of hypoglycemic episodes among the patients after consuming test meals with cooled rice compared to fresh ones during 180 min of observation (12(38) vs. 3(9), p = 0.0039).ConclusionsConsumption of rice subjected to the cooling process results in a lower increase of postprandial blood glucose in subjects with type 1 diabetes. At the same time it increases the risk of postprandial hypoglycemia using a standard insulin dose.

Structured self-monitoring of blood glucose is associated with more appropriate therapeutic interventions than unstructured self-monitoring: A novel analysis of data from the PRISMA trial

AimsTo investigate the relationship between single therapeutic interventions and indicatorsofglycemic control in the PRISMA trial, a large study comparing the effects of intensive structured SMBG (ISM) vs. active control (AC) in non-insulin-treated type 2 diabetes (T2D). MethodsInformation was collected at four time points, corresponding to months 3, 6, 9, and 12 and visits 2, 3, 4, and 5, respectively. Data on therapeutic interventions, HbA1c levels and the number of hypoglycemic episodes at each visit were analyzed. ResultsIntensification of drug therapy occurred in 20.3% vs. 15.6%, and no change in 71.8% vs. 78.7% of visits for the ISM and AC groups, respectively. On the other hand, de-intensification and redistribution of drugs and/or drug dose occurred in a similar proportion of visits. Intensification of drug therapy in both groups was associated with significant reductions in HbA1c vs. the previous visit, while de-intensification of therapy led to a significant increase in HbA1c in the AC group only. Conclusions. Our data strongly support that structured SMBG has clinical value in reducing HbA1c in non-insulin-treated T2D and suggest that this clinical benefit may be mediated by more appropriate and timely changes in drug therapy.

Continuous Blood Glucose Monitoring Increases Vigorous Physical Activity Levels and Is Associated With Reduced Hypoglycemia Avoidance Behavior In Youth With Type 1 Diabetes.

The primary goal of this study was to explore physical activity (PA) levels, hypoglycemia fear scores and hypoglycemia episodes according to insulin administration and blood glucose monitoring methods in youth with type 1 diabetes (T1D). A self-administered questionnaire was completed by 28 children and 33 adolescents with T1D, and their PA was assessed. Hypoglycemia episodes, fear of hypoglycemia scores, insulin therapy (pump vs. injection) and blood glucose monitoring (continuous blood glucose monitors [CGMs] vs. blood glucose meters) methods are reported in the present work. There were no significant differences in the number of hypoglycemic episodes, child hypoglycemia fear survey behavior or total scores, or any components of the PA profile between youth using injections and those using a pump. However, these variables differed significantly when compared according to blood glucose monitoring method (CGMs vs. blood glucose meters): 41.2 vs. 81.8, p<0.01; 1.03 ± 0.05 vs. 2.6 ± 0.63, p<0.01; 1.09 ± 0.43 vs. 2.94 ± 0.22, p<0.01; and 222 ± 18 vs. 49 ± 11, p<0.01 (for total time in vigorous PA in minutes per week), respectively. CGM use correlated significantly with VPA levels (β=0.6; p=0.04). Higher VPA levels were associated with higher child hypoglycemia fear survey behavior scores (β=0.52; p=0.04). The latter correlates negatively with the number of episodes of hypoglycemia in the past 12 months in all category groups. The type of insulin injection was not associated with more activity in youth with T1D. In contrast, CGM use may be associated with increased vigorous PA among T1D youth. Those with higher hypoglycemia fear survey behavior scores engaged in more VPA and had fewer hypoglycemia episodes. Although CGM use ensures continuous monitoring of glycemia during exercise, increasing hypoglycemia avoidance behavior is still a necessary part of exercise management strategies in active youth with T1D.

98-LB: Diabeloop DBL4K Hybrid Closed-Loop System Improves Time-in-Range without Increasing Time-in-Hypoglycemia in Children Aged 6–12 Years

Introduction: The DBLG1 Hybrid Closed-Loop system improves time in range and glycemic control in adults. However, the efficacy and safety of the system had not yet been evaluated in children. Objective: of this study is to evaluate the non-inferiority of the DBL4K (Diabeloop for Kids) hybrid closed-loop system (Kaleido pump + Dexcom G6 = CL) compared to a Dexcom G6 sensor augmented pump (open loop = OL) in prepubescent children. Materials and Methods: Multicenter open-label randomized controlled trial in 3 pediatric diabetology centers, 2 of which are French. The CL and OL are allocated for 4 days in hospital, followed by 6 weeks at home for the French centers. Results: Seventeen patients (mean age: 8.3+/- 1.6 years) were included for evaluation at 6 weeks at home between March and December 2019. The percentage of time spent in range (0.7-1.8 g/L) was significantly higher in the CL group during the 6 weeks at home (66.19% in CL vs. 58.68% in OL, p&amp;lt;0.001). The percentage of time spent in hypoglycemia (&amp;lt;0.7 g/L) was significantly lower in the CL group (2.62% in CL vs. 5.24% in OL, p&amp;lt;0.0001) as well as the number of hypoglycemic episodes (25.51 in CL vs. 48.16 in OL, p&amp;lt;0.0001). The coefficient of variation of blood glucose is significantly lower in CL group (31.85% in CL vs. 36.36% in OL, p&amp;lt;0.001). No events of ketoacidosis or severe hypoglycemia were recorded. Conclusions: The DBL4K Closed-Loop System is suitable for prepubescent children. It is not inferior to sensor augmented pump therapy in children. Just as in adults it improves the time in range while decreasing the time spent in hypoglycemia. It could allow for better long-term glucose control in children with diabetes. Disclosure D. Kariyawasam: None. C. Morin: None. K. Casteels: None. C. Le Tallec: None. C. Godot: None. A. Sfez: None. N. Garrec: None. M. Polak: Other Relationship; Self; AMMTeK. G. Charpentier: Other Relationship; Self; Diabeloop. S. Franc: Advisory Panel; Self; Diabeloop SA. Board Member; Self; Novo Nordisk. Research Support; Self; Merck Sharp &amp; Dohme Corp. Stock/Shareholder; Self; Diabeloop SA. Other Relationship; Self; Abbott Diabetes. J. Beltrand: None.

HbA1c Is Not Potent Glucose Control Assessment Tool in Type 2 Diabetes Patients Treated With Insulin

Abstract Glycated haemoglobin (HbA1c) is used for defining of glucose control in diabetic patients nevertheless its insufficiency to present overall control in some specific cases. Continuous Glucose Monitoring (CGM) is usually used for adjustment of insulin doses but the derived data are helpful for exact glucose control. We assess the potency of HbAc for defining of real glucose control in subgroup of type 2 diabetes patients treated with different insulin regimens. We studied 54 diabetic patients (33 men, 21 women; age 60.23±5.99 years, disease duration 12.64±5.02 years) - 33 with type 2 diabetes on pre-mixed insulin, 21 with type 2 on multiple insulin injection (MII). Patients performed multiple daily blood glucose measurements of fasting and prandial blood glucose for three months period. HbA1c was measured and CGM by using iProTM for seven days was performed at the end of this period. In pre-mixed insulin treated group and in intensified regimen group, moderate positive correlation was found between HbA1c and mean blood glucose derived from CGM (7.64±1.40% and 7.69±1.23%, respectively 7.64±1.48mmol/l and 7.60±1.30mmol/l), with r1=0.642 (p&amp;lt;0.01) and r2=0.570 (p&amp;lt;0.05). Even lower was correlation between HbA1c and time-in-range (r1=0.431 and r2 =0.401). There were no correlations between HbA1c and percentage of time spent below the target and number of hypoglycemic episodes in each group. Same trend of correlations was found comparing HbA1c and mean BG level in eight-point profile. Based on HbA1c assessment 36.36% of patients on premixed insulin, 19.05% of type 2 patients on MII were with good control. After estimation of results from SMBG these percentage were respectively 28.14% and 12.11%. CGM defined 27.27% of patients on premixed insulin, 13.80% of type 2 patients on MII as well controlled. We conclude that in insulin treated type 2 patients HbA1c gives relative information about overall control with no precise presenting of glucose fluctuations and out-of-range values of blood glucose with no information about hypoglycemic episodes. Nevertheless, short observed period CGM data could give much information that is comparable to three months blood glucose measurement and could replace the use of HbA1c for assessment of overall control. Reference: (1) Chehregosha H, et al. Diabetes Ther. 2019; 10, 853–863 (2) Beyond A1c Writing Group. Diab Care. 2018; 41: e92-e94 (3) Hirsch I et al. Diabetes Tech Ther 2017, 19 (3): S38-S48

Evidence generation for postprandial Insulin administration for better management of diabetes in noncritically iII patients

Introduction: Previously, premeal sliding scale insulin regimen was used to control sugar levels in hospitalized type-2 diabetes patients. However, the now recommended basal-bolus regimen also failed to show any substantial advantage over the traditional sliding scale regimen in the latest Cochrane review. Methodology: In this retrospective cohort study, data were collected from two groups of patients who received basal with premeal bolus regimen and those who received modified sliding scale regimen (basal with both pre- and lower dose postprandial insulin by sliding scale). The data collected were analyzed to compare the mean reduction in blood glucose level, number of hypoglycemic episodes, and mean hospital stay among the two groups. Results: A total of forty patients were included in the study. Twenty received basal with both pre- and postprandial insulin correction by sliding scale and other twenty received basal insulin with postmeal bolus correction regimen. The mean hospital stay in sliding scale with postprandial insulin correction was 3.9 ± 2.2 days, and in other group, it was 6.1 ± 4.47 days. Two out of twenty patients in the sliding scale with postprandial insulin group, whereas six out of twenty patients in the other group had hypoglycemic events. Conclusion: Basal with both pre- and postmeal (low dose) insulin by sliding scale might be an answer to the concerns of faster attainment of euglycemia in hospitalized type-2 diabetes patients with minimal risk of hypoglycemia. We plan a prospective study with a larger sample size to substantiate the evidence.

Continuous glucose monitoring for the prevention of morbidity and mortality in preterm infants.

Preterm infantsare susceptible tohyperglycemia andhypoglycemia, conditions which may lead to adverse neurodevelopment. The use of continuous glucose monitoring devices(CGM) might help keeping glucose levels in the normal range, and reduce the need for blood sampling. However, the useof CGM might be associated with harms in the preterm infant. Objective one: to assess the benefits and harms of CGM alone versus standard method of glycemic measure in preterm infants. Objective two: to assess the benefits and harms of CGM with automated algorithm versus standard method of glycemic measure in preterm infants. Objective three: to assess the benefits and harms of CGM with automated algorithm versus CGM without automated algorithm in preterm infants. We adopted the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 9), in the Cochrane Library; MEDLINE via PubMed (1966 to 25September 2020); Embase (1980 to 25September 2020); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to 25September 2020). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials. Randomized controlled trials (RCTs) and quasi-RCTs in preterm infants comparing: 1)the use ofCGMversus intermittent modalities to measure glycemia (comparison 1); orCGM associated with prespecified interventions to correct hypoglycemiaor hyperglycemia versus CGM without such prespecified interventions(comparison 2). We assessed the methodological quality of included trials using Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria (assessing randomization, blinding, loss to follow-up, and handling of outcome data). We evaluated treatment effects using a fixed-effect model with risk ratio (RR) for categorical data and mean, standard deviation (SD), and mean difference (MD) for continuous data. We used the GRADE approach to assess the certainty of the evidence. Four trials enrolling 138 infants met our inclusion criteria. Investigators in three trials (118 infants) comparedthe use ofCGM to intermittent modalities (comparison one); however one of these trialswas analyzedseparately because CGMwas used as a standalone device, without being coupled to a control algorithm like in the other trials. A fourth trial (20infants) assessed CGM with an automated algorithm versus CGM with a manual algorithm. None of the four included trials reported the neurodevelopmental outcome, i.e. the primary outcome of this review. Within comparison one, the certainty of the evidence on the use of CGM on mortality during hospitalization is very uncertain (typical RR 3.00,95% CI 0.13 to70.30; typical RD 0.04, 95% CI -0.06to 0.14; 50 participants; 1 study; very low certainty). The number of hypoglycemic episodes was reported in two studies with conflicting data. The number of hyperglycemic episodes was reported in one study(typical MD -1.40,95% CI -2.84to 0.04; 50 participants; 1 study). The certaintyof the evidence was very low for all outcomesbecause of limitations in study design, and imprecision of estimates. Threestudiesareongoing. There is insufficient evidence to determine if CGM improves preterm infant mortality or morbidities. Long-term outcomeswerenot reported. Clinical trials are required to determine the most effective CGM and glycemic management regimens in preterm infants before larger studies can be performed to assess the efficacy of CGMfor reducing mortality, morbidity and long-term neurodevelopmental impairments.The absence of CGM labelled for neonatal use is still a major limit in its use as well as the absence of dedicated neonatal devices.

Personality Traits, Metabolic Control and the Use of Insulin Pump Functions in Adults With Type 1 Diabetes: An Observational Single-Visit Study

IntroductionWhile a few studies have assessed the association between personality and metabolic outcomes in children and adolescents with type 1 diabetes (T1DM), there have been none in adults or in subjects treated with insulin pumps, and hypoglycaemic episodes have not been considered in these studies. The aim of this observational single-visit study was to assess the association between personality traits and metabolic control, hypoglycaemic episodes and insulin pump use in adult T1DM patients.MethodsData were obtained from 52 adults with T1DM treated in a tertiary care centre (no complications or comorbidities; aged 27 ± 8 years; diabetes duration of 12.8 ± 6.8 years; treated with insulin pumps for 6.3 ± 0.4 years). “Big Five” personality traits (neuroticism, extraversion, openness, agreeableness and conscientiousness) were assessed using the NEO-Five Factor Inventory questionnaire. Data on HbA1c, blood glucose levels, frequency of glucose testing, the number of hypoglycaemic episodes (< 3.9 mmol/l), basal and prandial insulin doses, and the number and types of boluses in the last 14 days were obtained from the insulin pumps and glucometers.ResultsThe mean levels of the assessed parameters were: HbA1c 7.2 ± 1.2% (55.0 ± 13.1 mmol/mol), episodes of hypoglycaemia 7.0 (3.00–9.75) and glucose tests per day 7.3 ± 3.9. All personality traits showed average intensity. None of the traits were associated with HbA1c, glycaemia, number of glucose tests, or number or kind of insulin boluses. Conscientiousness was the only factor associated with the incidence of hypoglycaemia in both univariate (r = + 0.46, p < 0.001) and multivariate (β = + 0.41, p < 0.001) analyses.ConclusionsDespite results reported for children and adolescents, personality traits of adult patients with T1DM were not essential for metabolic control assessed by HbA1c or for the use of insulin pump functions; however, higher conscientiousness may be related to more frequent hypoglycaemic episodes. Extrinsic factors should be searched as more relevant for metabolic control and proper use of very expensive insulin pump therapy.

Anticipation of Historical Exercise Patterns by a Novel Artificial Pancreas System Reduces Hypoglycemia During and After Moderate-Intensity Physical Activity in People with Type 1 Diabetes.

Objective: Physical activity is a major challenge to glycemic control for people with type 1 diabetes. Moderate-intensity exercise often leads to steep decreases in blood glucose and hypoglycemia that closed-loop control systems have so far failed to protect against, despite improving glycemic control overall. Research Design and Methods: Fifteen adults with type 1 diabetes (42 ± 13.5 years old; hemoglobin A1c 6.6% ± 1.0%; 10F/5M) participated in a randomized crossover clinical trial comparing two hybrid closed-loop (HCL) systems, a state-of-the-art hybrid model predictive controller and a modified system designed to anticipate and detect unannounced exercise (APEX), during two 32-h supervised admissions with 45 min of planned moderate activity, following 4 weeks of data collection. Primary outcome was the number of hypoglycemic episodes during exercise. Continuous glucose monitor (CGM)-based metrics and hypoglycemia are also reported across the entire admissions. Results: The APEX system reduced hypoglycemic episodes overall (9 vs. 33; P = 0.02), during exercise (5 vs. 13; P = 0.04), and in the 4 h following (2 vs. 11; P = 0.02). Overall CGM median percent time <70 mg/dL decreased as well (0.3% vs. 1.6%; P = 0.004). This protection was obtained with no significant increase in time >180 mg/dL (18.5% vs. 16.6%, P = 0.15). Overnight control was notable for both systems with no hypoglycemia, median percent in time 70-180 mg/dL at 100% and median percent time 70-140 mg/dL at ∼96% for both. Conclusions: A new closed-loop system capable of anticipating and detecting exercise was proven to be safe and feasible and outperformed a state-of-the-art HCL, reducing participants' exposure to hypoglycemia during and after moderate-intensity physical activity. ClinicalTrials.gov NCT03859401.

Reduced Rates of Hypoglycemia in Type 1 or Type 2 Diabetes After Switching to Insulin Degludec: Results from the Italian Cohort of the ReFLeCT Study

IntroductionTo evaluate in an Italian real-world setting the safety and effectiveness of insulin degludec 100 units/mL, given once daily in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) after switching from other basal insulins.MethodsReFLeCT was a multicenter, prospective, observational study conducted across seven European countries which involved adult patients whose physician planned to switch their medication from basal insulin to insulin degludec. The primary outcome was the change in the number of hypoglycemic episodes before and after the switch to insulin degludec. Results are expressed as 12-month follow-up/baseline incidence rate ratios (IRRs) with 95% confidence intervals (95% CIs).ResultsThe Italian cohort of the ReFLect study comprised 148 patients with T1DM and 311 patients with T2DM. In patients with T1DM, the switch to insulin degludec was associated with significantly lower rates of overall (IRR 0.69, 95% CI 0.57–0.82), non-severe (IRR 0.72, 95% CI 0.60–0.85), and nocturnal hypoglycemia (IRR 0.46, 95% CI 0.31–0.69). Following the switch, hemoglobin A1c (HbA1c) levels decreased significantly by 0.35% (95% CI − 0.50 to − 0.20), with no significant changes in fasting plasma glucose (FPG) and basal insulin dose. Body weight increased by 0.83 kg (95% CI 0.16–1.50). In patients with T2DM, significant reductions in the rates of overall (IRR 0.40, 95% CI 0.29–0.55), non-severe (IRR 0.47, 95% CI 0.34–0.63), and nocturnal hypoglycemia (IRR 0.27, 95% CI 0.09–0.86) were documented. HbA1c and FPG decreased significantly by 0.45% (95% CI − 0.58 to − 0.31) and 0.90 mmol/L (95% CI − 1.21 to − 0.59], respectively, with no significant changes in basal insulin dose or body weight. Treatment satisfaction significantly improved in both diabetes types.ConclusionIn Italian routine clinical practice, switching from other basal insulins to insulin degludec reduced the total episodes of hypoglycemia and improved glycemic control and treatment satisfaction in patients with T1DM and T2DM.Trial RegistrationClinicalTrials.gov NCT02392117.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-020-00936-5) contains supplementary material, which is available to authorized users.

Use of Personal Continuous Glucose Monitoring Device Is Associated With Reduced Risk of Hypoglycemia in a 16-Week Clinical Trial of People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion.

Continuous glucose monitoring (CGM) has the potential to promote diabetes self-management at home with a better glycemic control as outcome. Investigation of the effect of CGM has typically been carried out based on randomized controlled trials with prespecified CGM devices on CGM-naïve participants. The aim of this study was to investigate the effect on glycemic control in people using their personal CGM before and during the trial. Data from the Onset 5 trial of 472 people with type 1 diabetes using either their personal CGM (n = 117) or no CGM (n = 355) and continuous subcutaneous insulin infusion in a 16-week treatment period were extracted. Change from baseline in glycated hemoglobin A1c (HbA1c), number of hypoglycemic episodes, and CGM metrics at the end of treatment were analyzed with analysis of variance repeated-measures models. Use of personal CGM compared with no CGM was associated with a reduction in risk of documented symptomatic hypoglycemia (event rate ratio: 0.82; 95% CI: 0.69-0.97) and asymptomatic hypoglycemia (event rate ratio: 0.72; 95% CI: 0.53-0.97), reduced time spent in hypoglycemia (P = .0070), and less glycemic variability (P = .0043) without a statistically significant increase in HbA1c (P = .2028). Results indicate that use of personal CGM compared with no CGM in a population of type 1 diabetes is associated with a safer glycemic control without a statistically significantly deteriorated effect on HbA1c, which adds to the evidence about the real-world use of CGM, where device type is not prespecified, and users are not CGM naïve.

Quality improvement project for improving inpatient glycaemic control in non-critically ill patients admitted on medical floor with type 2 diabetes mellitus

A significant number of patients admitted to the medical floor have type 2 diabetes mellitus (DM). Lack of a standardised inpatient hyperglycaemia management protocol leads to improper glycaemic control adding...