Safety and glycemic outcomes of do-it-yourself AndroidAPS hybrid closed-loop system in adults with type 1 diabetes.

BACKGROUND: The aim of the study was to assess the safety and glycemic outcomes with the use of a Do-It-Yourself (DIY) Hybrid Closed-Loop (HCL) system based on the AndroidAPS application in type 1 diabetes (T1D). METHODS: Single-center clinical trial, with 3-week run-in and 12-week study period. DIY HCL system consisted of the Dana Diabecare RS insulin pump, Dexcom G5 continuous glucose monitoring system and AndroidAPS application. Primary outcome was safety: incidences of severe hypoglycemia, diabetic ketoacidosis, time spent in glycemia <54 mg/dl. Secondary endpoints included percentage of time in range (TIR) 70-180 mg/dl, time below 70 mg/dl, HbA1c, insulin requirements, and body weight. RESULTS: In total 12 subjects (5 men, 7 women) were enrolled, mean age 31.3±6.7, 95%CI(27.7-34.9) years, mean diabetes duration 16.1±5.7, 95%CI(13.0-19.2) years. No episodes of severe hypoglycemia or ketoacidosis were observed. Percentage of time spent in glycemia below 54mg/dl was not increased. Average sensor glycemia was lower in the study period than baseline (141.1 ± 8.4, 95%CI(136.3-145.9) vs. 153.3 ± 17.9, 95%CI(143.2-163.4), mg/dl p<0.001). TIR 70-180 mg/dl was improved by 11.3%, 95%CI(2.8%-19.8%) (from 68.0 ± 12.7 to 79.3 ± 6.4%, p<0.001), without increasing hypoglycemia time. The HbA1c level decreased by -0.5%, 95%CI(-0.9%--0.1%) (from 6.8 ± 0.5 to 6.3 ± 0.4%, p<0.001). Additionally, in the last 4 weeks of the study period participants significantly improved and showed TIR 70-180 mg/dl 82.1 ± 5.6%, 95%CI(78.9-85.3), time <54 mg/dl 0.30 (0.20-0.55)%, median 95%CI(0.1-0.7) and <70 mg/dl 1.90 (1.10-3.05)%, median 95%CI(0.7-3.2). The insulin requirement and body weight did not change in the study. CONCLUSIONS: The study revealed safety of the Do-It-Yourself HCL system AndroidAPS in adults with T1D, limited to well-controlled, highly selected and closely monitored patients. The use of AndroidAPS significantly improved HbA1c, time in range and average sensor glycemia without increasing hypoglycemia. As both patients and their medical team are gaining experience using the system over time, they improve glycemic control. TRIAL REGISTRATION: German Clinical Trials Register: no. DRKS00015439; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015439.

Characteristics of Selected Somatic and Motor Abilities of Youth Soccer Players with Diabetes Type 1 Treated with Insulin Pump Therapy.

Long-term insulin treatment can slow the growth process and decrease physical fitness level in children. In diabetic children, these two developments should be constantly monitored. The aim of the present study was to examine differences in somatic and physical fitness characteristics between soccer-training boys with type 1 diabetes and healthy boys of the same age (reference values based on Polish population norms for somatic and motor parameters). The participants were 94 boys (8-17 years), diagnosed with diabetes, who participated in soccer training on a regular basis and received routine medical care. The study involved (a) anthropometric and body composition measurements, (b) general motor ability assessments, and (c) comparison of those characteristics with the healthy Polish population. The diabetic boys were found to have lower levels of almost all somatic traits and motor abilities as compared with the healthy boys (p ≤ 0.05). Handgrip strength was a variable with the smallest difference between the two groups. The observed differences indicate the necessity to design an appropriate control and assessment system based on simple medical and fitness field tests for diabetic children and adolescents. It will allow optimizing advanced training as well as minimize health risks before, during, or after exercise.

Responses to Low- and High-Intensity Exercise in Adolescents with Type 1 Diabetes in Relation to Their Level of VO2 Max.

The purpose of this study was to investigate the influence of maximal oxygen uptake (VO2 max) on the glycemic changes during low and high intensity exercises in young type 1 diabetic patients. Twenty boys (age: 14.3 ± 1.6 years; height: 171.0 ± 11.3 cm; weight; 59.5 ± 12.8 kg) were divided into low-fit group (LFG, n = 10) and high-fit group (HFG, n = 10). According to the experimental design, participants performed three physical efforts (VO2 max test, mixed aerobic-anaerobic effort and aerobic effort) on the cycloergometer, during which real-time glycemia was measured. Mixed aerobic-anaerobic exercise demanded significantly smaller carbohydrate supplementation (0.2 ± 0.2 g/kg during exercise) than the aerobic test session (0.4 ± 0.3 g/kg during exercise). Moreover, patients with higher VO2 max had lower tendency for glycemic changes during the aerobic effort. The results of the current study suggest that young type 1 diabetic patients should perform different intensity activities using continuous glycemic monitoring system to avoid acute and chronic complications of the disease.

Assessment of changes in blood lactate levels in children and adolescents with type 1 diabetes during a football tournament (GoalDiab Study).

INTRODUCTION: Monitoring physical activity is a very important issue, especially in type 1 diabetes. One of the parameters assessing the intensity of exercise is the concentration of lactate in the blood. Aim of the study We assessed the intensity of PE and changes in lactate levels in children and adolescents with type 1 diabetes (T1D) during a football tournament. MATERIAL AND METHODS: We enrolled 141 participants, the results of 70 of whom were analyzed, playing in two age categories: 10-13 and 14-17 years. Lactate levels were measured in the capillary blood before and after matches. Blood lactate of 4 mmol/l (Onset Blood Lactate Accumulation OBLA) was used as parameter indicating the prevalence of anaerobic metabolic changes. RESULTS: The median lactate level was 1.8 mmol/l before and 4.4 mmol/l after matches (p < 0.001). The increase in lactate levels was higher in the older age category (4.3 vs. 1.8, p = 0.001) and was independent on gender (3.2 vs. 2.1, p = 0.597), personal insulin pump vs insulin pen use (3.0 vs. 1.5, p = 0.145) or training in a sports club (1.4 vs. 3.0, p = 0.084). A positive correlation was noted between increased lactate levels and age (Rs = 0.253, p = 0.034). 61% of the participants exceeded lactate levels ≥ 4 mmol/l. In univariate logistic regression analysis age was a significantly associated with lactate level ≥ 4 mmol/l [OR = 1.45 (1.08-1.95)] independent of HbA1c, gender, treatment method and training in a sports club. CONCLUSIONS: PE intensity levels during football matches were found to be mixed aerobic-anaerobic. Increases in lactate levels were greater in the older subjects independently on the assessed factors.

Impact of factory-calibrated Freestyle Libre System with new glucose algorithm measurement accuracy and clinical performance in children with type 1 diabetes during summer camp.

BACKGROUND: Factory-calibrated intermittently-scanned Continuous Glucose Monitoring (isCGM) device FreeStyle Libre (FSL) has recently received improvements in its glucose tracking algorithm and calibration procedures, which are claimed to have improved its accuracy. OBJECTIVE: To compare the accuracy of two generations of 14-days FSL devices (A in 2016, B in 2019) to self-monitored blood glucose measurements (SMBG) in children with type 1 diabetes in real-life conditions during a summer camp. MATERIALS AND METHODS: Two largely independent groups of youth with type 1 diabetes took part in summer camps. In 2016 they used FSL-A, in 2019 FSL-B. On scheduled days, participants performed supervised 8-point glucose profiles with FSL and SMBG. The accuracy vs SMBG was assessed with mean absolute relative difference (MARD) and clinical surveillance error grid (SEG). RESULTS: We collected 1655 FSL-SMBG measurement pairs from 78 FSL-A patients (age 13 ± 2.3 years old; HbA1c: 7.6 ± 0.8%) and 1796 from 58 in FSL-B group (age 13.8 ± 2.3 years old, HbA1c: 7.5 ± 1.1%)-in total 3451 measurements. FSL-B displayed lower MARD than FSL-A (11.3 ± 3.1% vs 13.7 ± 4.6%, P = .0003), lower SD of errors (20.2 ± 6.7 mg/dL vs 24.1 ± 9.6 mg/dL, P = .0090) but similar bias (-7.6 ± 11.8 mg/dL vs -6.5 ± 8 mg/dL, P = .5240). Both FSL-A and FSL-B showed significantly higher MARD when glycaemia was decreasing >2 mg/dL/min (FSL-A:22.3 ± 18.5%; FSL-B:17.9 ± 15.8%, P < .0001) compared with stable conditions (FSL-A: 11.4 ± 10.4%, FSL-B:10.1 ± 9.1%) and when the system could not define the glycaemic trend (FSL-A:16.5 ± 16.3%; FSL-B:15.2 ± 14.9%, P < .0001). Both generations demonstrated high percentage of A-class and B-class results in SEG (FSL-A: 96.4%, FSL-B: 97.6%) with a significant shift from B (decrease by 3.7%) to A category (increase by 3.9%) between generations (FSL-A: 16/80.4%; FSL-B:12.3/85.3%, P = .0012). CONCLUSION: FSL-B demonstrated higher accuracy when compared to FSL-A However, when glycemia is decreasing or its trend is uncertain, the verification with a glucose meter is still advisable.

Physiological Characteristics of Type 1 Diabetes Patients during High Mountain Trekking.

In this study, the aim was to provide observational data from an ascent to the summit of Mount Damavand (5670 meters above sea level (m.a.s.l), Iran) by a group of people with type 1 diabetes (T1DM), with a focus on their physiological characteristics. After a 3-day expedition, 18 T1DM patients, all treated with personal insulin pumps, successfully climbed Mount Damavand. Information was collected on their physiological and dietary behaviors, as well as medical parameters, such as carbohydrate consumption, glucose patterns, insulin dosing, and the number of hypo- and hyperglycemic episodes during this time frame. The participants consumed significantly less carbohydrates on day 3 compared to day 1 (16.4 vs. 23.1 carbohydrate units; p = 0.037). Despite this, a gradual rise in the mean daily glucose concentration as measured with a glucometer was observed. Interestingly, the patients did not fully respond to higher insulin delivery as there was no significant difference in mean daily insulin dose during the expedition. There were more hyperglycemic episodes (≥180 mg/dL) per patient on day 3 vs. day 1 (p < 0.05) and more severe hyperglycemic episodes (>250 mg/dL) per patient on days 2 (p < 0.05) and 3 (p < 0.05) vs. day 1. In summary, high mountain trekking is feasible for T1DM patients with good glycemic control and no chronic complications. However, some changes in dietary preferences and an observable rise in glucose levels may occur. This requires an adequate therapeutic response.

Nighttime Hypoglycemia in Children with Type 1 Diabetes after one Day of Football Tournament.

The aim of the study was to investigate factors related to the occurrence of nighttime hypoglycemia after a football tournament in children with type 1 diabetes mellitus. The multicenter study (GoalDiab study) included 189 children and adolescents with type 1 diabetes mellitus, from 11 diabetes care centers in Poland. Hypoglycemia was defined according to the International Hypoglycemia Study Group Statement. We analyzed the data of 95 participants with completed protocols with regards to nighttime hypoglycemia (82% male), aged 11.6 (9.8-14.2) years, diabetes duration 5.0 (2.0-8.0) years. There were 47 episodes of nighttime Level 1 hypoglycemia (≤3.9 mmol/L). Occurrence of clinically important Level 2 hypoglycemia (<3.0 mmol/L) during a game period was positively associated with nighttime hypoglycemia (≤3.9 mmol/L) incident (Odds Ratio=10.7; 95% Confidence Interval: 1.1-100.2; p=0.04). Using Continuous Glucose Monitoring was negatively associated with the occurrence of nighttime hypoglycemia (≤3.9 mmol/L) compared with using glucose meters or Flash Glucose Monitoring (Odds Ratio=0.31; 95% Confidence Interval: 0.12-0.83; p=0.02). The occurrence of clinically important hypoglycemia related to physical activity is associated with the occurrence of hypoglycemia during the night. Continuous Glucose Monitoring is negatively associated with nighttime hypoglycemia after a day of competition.

Physical workload and glycemia changes during football matches in adolescents with type 1 diabetes can be comparable.

AIMS: To analyze physical performance and diabetes-related outcomes in adolescents with type 1 diabetes (T1DM) during two semi-competitive football matches utilising precise physical activity monitoring. METHODS: The study was conducted during an annual summer camp for adolescents with T1DM. After physical examination and glycated hemoglobin measurement, 16 adolescent players completed Cooper's 12-min running test and, in the following days, took part in two football matches while wearing heart rate (HR) monitors coupled with global positioning system (GPS) tracking. RESULTS: Both matches were comparable in terms of covered distances, number of sprints, achieved velocities and heart rate responses. During both games, capillary blood lactate increased significantly (Match 1: 1.75 ± 0.16-6.13 ± 1.73 mmol/l; Match 2: 1.77 ± 0.18-3.91 ± 0.63 mmol/l, p = 0.004). No significant differences in blood glucose were observed between the matches (p = 0.83) or over each match (p = 0.78). Clinically significant hypoglycemia (< 54 mg/dl) occurred in two children during the first match. None of the players experienced severe hypoglycemia. Despite similar workloads, players consumed significantly less carbohydrates during Match 2 [median difference: - 20 g (25-75%: - 40 to 0), p = 0.006]. CONCLUSIONS: HR monitoring and GPS-based tracking can effectively parameterize physical activity during a football match. In T1DM patients, exercise workload and glycemic changes during similar matches are comparable, which provides an opportunity to develop individual recommendations for players with T1DM.

Assessment of Safety and Glycemic Control During Football Tournament in Children and Adolescents With Type 1 Diabetes-Results of GoalDiab Study.

PURPOSE: To assess glycemic control and safety of children and adolescents with type 1 diabetes participating in a 2-day football tournament. METHODS: In total, 189 children with type 1 diabetes from 11 diabetes care centers, in Poland, participated in a football tournament in 3 age categories: 7-9 (21.2%), 10-13 (42.9%), and 14-17 (36%) years. Participants were qualified and organized in 23 football teams, played 4 to 6 matches of 30 minutes, and were supervised by a medical team. Data on insulin dose and glycemia were downloaded from personal pumps, glucose meters, continuous glucose monitoring, and flash glucose monitoring systems. RESULTS: The median level of blood glucose before the matches was 6.78 (4.89-9.39) mmol/L, and after the matches, it was 7.39 (5.5-9.87) mmol/L (P = .001). There were no episodes of severe hypoglycemia or ketoacidosis. The number of episodes of low glucose value (blood glucose ≤3.9 mmol/L) was higher during the tournament versus 30 days before: 1.2 (0-1.5) versus 0.7 (0.3-1.1) event/person/day, P < .001. Lactate levels increased during the matches (2.2 [1.6-4.0] mmol/L to 4.4 [2.6-8.5] mmol/L after the matches, P < .001). CONCLUSIONS: Large football tournaments can be organized safely for children with type 1 diabetes. For the majority of children, moderate mixed aerobic-anaerobic effort did not adversely affect glycemic results and metabolic safety.

Assessment of Exercise Capacity in Children with Type 1 Diabetes in the Cooper Running Test.

Regular physical activity increases lifespan for those with type 1 diabetes. However, disease-related barriers may deter children from exercise and affect their fitness. This study examined the safety of the Cooper test concerning diabetes-related acute complications in children with type 1 diabetes and their fitness. Blood glucose was recorded before and 0, 30, 60 min after the test. The covered distances were transformed to z-scores based on the national charts. Body mass index, body fat percentage and glycated hemoglobin were measured. The run was completed by 80 individuals (45% boys, age 13.6±2.1 years; diabetes duration 6.3±3.5 years). During the follow-up 11 children reached glucose alert values (3-3.9 mmol/L), 3 presented clinically significant hypoglycemia (<3 mmol/L), none experienced severe hypoglycemia. The covered distance was 1914±298 m, not significantly different from the reference population (z-score -0.12±0.71 vs 0, p=0.12). The study participants were more overweight than general pediatric population in terms of body mass index (z-score 0.48±0.94 vs 0, p<0.001) and body fat percentage (z-score: 0.37±0.85 vs 0, p<0.001). In conclusion, the Cooper test can be safely used in children with diabetes to assess their physical capacity. Youth with type 1 diabetes present fitness similar to healthy children but exhibit increased body mass index and adiposity.

Safe Completion of a Trail Running Ultramarathon by Four Men with Type 1 Diabetes.

In this brief report, we describe the feat of four men with type 1 diabetes mellitus (T1DM) who decided to take part in a mountain ultramarathon in Bieszczady, Poland on May 27, 2016. Before participating in the competition, they asked two diabetologists for a consultation and to assist in diabetic control during the marathon. The aim of the study was to assess the metabolic safety in people with T1DM during extreme physical exertion in a mountain ultramarathon. All subjects were treated with continuous subcutaneous insulin infusion. The marathon route was 82 km, and the sum of the climbs and descents was 3235 and 3055 m, respectively. Diabetologists controlled glucose levels using a glucometer, plasma lactate levels, and ketones in the capillary blood. In addition, they monitored the intake of carbohydrates and fluids. Clinical tests were performed at the three checkpoints (at 32, 49, and 66 km) during the race and after completing the race (at 82 km). This study shows that extreme physical exertion by a person with type 1 diabetes is possible. All subjects avoided severe hypoglycemia by significantly reducing their insulin dose and consuming additional carbohydrates. Such actions, despite the occurrence of hyperglycemia >250 mg/dL did not result in ketoacidosis. Safe participation in mountain ultramarathons by people with type 1 diabetes can be achieved if they undertake appropriate physical and diabetologic preparation.

Flash Glucose Measurements in Children with Type 1 Diabetes in Real-Life Settings: To Trust or Not to Trust?

BACKGROUND AND AIMS: To evaluate the clinical accuracy of a flash glucose monitoring device FreeStyle Libre (FSL) among children with type 1 diabetes in real-world settings during a summer camp. MATERIALS AND METHODS: During a summer camp, children with type 1 diabetes (n = 79, aged 8-18 years) were provided with FSLs for 12 days. On days 3, 7, and 11 of the study, they underwent supervised glucose testing at 8 timepoints. Glycemia was estimated by using FSL and measured with a personal glucometer within a period of 2 min. The glucose trend arrows were recorded. RESULTS: The study was completed by 78 children (median: age 12.8 years, diabetes duration 5.8 years, HbA1c 58.5 mmol/mol). Mean absolute relative difference (MARD) between the FSL and the glucometer was 13.5% ± 12.9%. FSL was the most accurate in stable glycemic conditions: MARD 11.4% ± 10.4%, less accurate when glycemia was falling >2 mg/(dL·min) [0.111 mmol/(L·min)-MARD 22.6% ± 18.6%; P < 0.001 vs. stable conditions] and when the device could not determine the glucose trends (16.5% ± 16.3%, P = 0.01 vs. stable conditions). The FSL demonstrated lower accuracy during the day than the night [MARD 14.9% ± 14% vs. 11.2% ± 10.6%, P < 0.0001]. Out of 1655 data pairs of glucometer and FSL, using the Surveillance Error Grid methodology we determined that 80.36% of FSL readings were associated with no clinical risk, 18.73% with slight risk and only one high-risk measurement was detected. CONCLUSION: FSL is accurate in children, but its accuracy depends on the glucose trend. Results flagged by the rapid fall flag and "trend undetermined" should be verified by blood glucose measurements.

Type 1 Diabetes at High Altitude: Performance of Personal Insulin Pumps and Patient Metabolic Control.

High-altitude trekking can expose people to extreme environmental conditions, like low temperatures and hypobaric hypoxia. Such extreme conditions make it more difficult for people with type 1 diabetes mellitus (T1DM) to maintain glycemic control. Intensive blood glucose monitoring using either glucose meters or continuous systems is imperative in these cases. In this observational study, we report metabolic control of T1DM patients and the performance of various insulin pumps at high altitude. All 19 patients with T1DM included in this study participated in the final step of the "5000 meters above sugar level" initiative, which involved trekking Damavand Mountain to an altitude of 5670 meters above sea level. We found that all pump models worked well without any disruption and no cases of diabetes decompensation or severe hypoglycemia occurred. Therefore, healthy, physically fit, and experienced individuals with T1DM should not be discouraged from participating in mountain trekking activities, as modern personal insulin pumps work well at high altitudes.

High-intensity Exercise in Men with Type 1 Diabetes and Mode of Insulin Therapy.

The purpose of this study was to evaluate the impact of high intensity exercise on glucose levels and risk of metabolic decompensation in males with type 1 diabetes (T1D), depending on the method of insulin administration. The study comprised 29 males (aged 25.3±5.1 years; duration of diabetes 10.3±3.2 years) treated with continuous subcutaneous insulin infusion (CSII) or multiple daily insulin injections (MDI). Treadmill exercise test was performed twice in each patient until subjective exhaustion as maximum according to the Borg scale. All the patients achieved ≥85% of the maximal heart rate. Distance during the test was 4 500±1 400 m and 4 473±1 559 m in the MDI and CSII groups, respectively, which was achieved in 31±8 min. During the test and in the 6 h after, no clinically significant episodes of hypoglycemia occurred. Mean glucose levels did not exceed 10 mmol/L in most patients. The risk of the composite endpoint (hypoglycemia<3.8 mmol/L, hyperglycemia≥16.6 mmol/L, ketones≥0.6 mmol/L, and lactate>2.2 mmol/L) was higher in patients treated with MDI than CSII (OR3.75, 95%CI:1.22-11.52, p=0.02). In conclusion, planned high intensity physical effort in men with well-controlled T1D is metabolically safe. CSII shows greater metabolic advantage over MDI during and after high intensity exercise in men with T1D.

[Proposals for therapeutic decisions according to glucose trends in patients with type 1 diabetes]. / Propozycje decyzji terapeutycznych w zaleznosci od trendów glikemii u pacjentów z cukrzyca typu 1.

Nowadays, self-management of diabetes is more and more often based on continuous and flash glucose monitoring systems. In addition to measuring current glucose levels, both systems provide blood glucose levels from the past few hours in the form of a graph, as well as an indication of glucose trends via arrows. This information adds a new dimension to the self-management of diabetes, and should result in the modification of diabetes therapy. The paper presents proposals for modifications of treatment decisions based on glucose trends in patients with type 1 diabetes. By considering glucose trends, it is hoped that glycemic variability and numbers of hypoglycemia and hyperglycemia episodes will be reduced.