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Introduction: While people with diabetes (PWD)'s experiences with their insulin delivery systems (IDS) are frequently reported in clinical trials, few real-world data exist on the subject. This study aimed to assess the real-world experience and satisfaction with IDS in PWD., Methods: This cross-sectional survey of PWD treated with tubed or tubeless insulin pumps, hybrid closed loop (HCL) systems, or multiple daily injections (MDI) for at least 3 months ran from 4 to 16 May 2023. The questionnaire containing bespoke questions and the Insulin Delivery System Rating Questionnaire (IDSRQ) satisfaction and interference subscales was answered by subscribers of the Aide aux Jeunes Diabétiques patient association and users of the MyDiabby Healthcare web platform., Results: Of 896 analysable respondents (552 children [age 10.7 ± 3.8 years, 46.9% female, all type 1] and 344 adults [age 43.1 ± 19.3 years, 61.9% female, 87.2% type 1]), HCL and pump users reported greater satisfaction with their IDS on the IDSRQ satisfaction subscale (HCL, 70.9 ± 17.7 [n = 208]; tubeless, 66.6 ± 19.1 [n = 272]; tubed, 64.1 ± 21.6 [n = 215]) than MDI users (53.1 ± 23.0 [n = 201]; all p < 0.001). Regarding the interference subscale, tubeless pumps (31.1 ± 24.8) performed similarly to HCLs (37.0 ± 25.5; p = 0.07) and significantly better than tubed pumps (38.6 ± 26.0; p < 0.001) and MDI (42.2 ± 24.3; p < 0.001). Furthermore, 84.6% of tubeless pump users would retain their style of pump for their ideal HCL, almost twice as often as tubed pump users., Conclusion: These results demonstrate a more positive person-reported experience with HCLs or tubeless pumps than with tubed pumps or MDI, primarily due to less interference with daily life, which most tubeless pump users would like to retain when transitioning to a HCL system. Overall, this pioneering study underscores the importance of patient preferences, providing valuable information for physicians prescribing IDS, and facilitating discussions about treatment options., Competing Interests: Declarations. Conflict of Interest: Jacques Beltrand has received speaker Honoraria from Abbott, Medtronic, Lilly, Sanofi Winthrop, Ypsomed, Merckx and Novo Nordisk and served on advisory board panels for Sanofi Winthrop, Medtronic, Insulet and Lilly. Pierre-Yves Benhamou. has received speaker honoraria from Abbott, Eli Lilly, Novo Nordisk and Sanofi, is chief medical officer for Diabeloop, and served on advisory board panels for Abbott, Dexcom, Insulet, LifeScan, Eli Lilly, Pharmasens, Novo Nordisk and Sanofi. Carine Choleau has no conflict of interest to declare. Ben Braithwaite has no conflict of interest to declare. Alice Bonin is an employee of Insulet France SAS. Jean-Pierre Riveline is an advisory panel member for Sanofi, MSD, Eli Lilly, Novo Nordisk, AstraZeneca, Abbott, Dexcom, Alphadiab, and Medtronic, and has received research funding and provided research support to Abbott, Air Liquide, Sanofi, and Novo Nordisk. Ethical Approval: This study was not subject to approval from a regulatory ethics committee, in accordance with article R1121-1 of the French Public Health Code. However, the questionnaire was reviewed by a French scientific committee of diabetes specialists. All procedures in this study complied with the laws and regulations regarding the management of personal information applicable in France, as well as the European General Data Protection Regulation. The study was conducted in accordance with the Guidelines for Good Pharmacoepidemiology Practices and the Declaration of Helsinki [8]. Informed Consent: Informed consent was obtained from all users (person with diabetes or their legal guardian, as appropriate) in the form of a non-opposition statement before showing the questionnaire, as required by article R1121-1 of the French Public Health Code. The information notice also stated that the overall results of the survey, which will be fully anonymized, will be available on the partners’ websites., (© 2024. The Author(s).)

Aims: To estimate type 1 diabetes incidence in children in France and its evolution between 2010 and 2015, based on comprehensive medico-administrative databases., Methods: The algorithm built to identify new cases of type 1 diabetes selected children aged between 6 months and 14 years who had at least one hospital stay for diabetes, followed by their first insulin treatment, excluding children suffering from another form of diabetes. Age and sex specific annual incidence rates were estimated and time trend was analyzed using Poisson regression., Results: A total of 12 067 children were identified as newly diagnosed with type 1 diabetes and the annual incidence rates increased between 2010 and 2015 (from 15.4 [95% Confidence Interval: 14.7; 16.1] to 19.1 [18.3; 19.9] per 100 000 person-years), among boys and girls, and in each age group (4 and under, 5-9, 10-14 year olds). The annual rate of increase was 4.0% [3.4; 4.6]. This trend was not significantly different between each gender, and each age group., Conclusions: Valid database information on disease incidence is essential for healthcare planning and provides a valuable resource for health research. An increase of the incidence rate of type 1 diabetes in children was highlighted in both sexes and in all age groups., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Objective: To evaluate diabetes knowledge and skills (DKS) in adolescents (>10 year) with type 1 diabetes (T1D) and their parents, and its effect on glycemic control., Methods: A ready-to-use program and a standardized questionnaire comprising 50 true-false questions based on this program, were elaborated by a National Committee, to help dispensing education at diagnosis of T1D. The questionnaire was completed by 2933 T1D patients (49% girls, 51% boys; 14.1 ± 2.5 year), 2180 mothers and 798 fathers, in 115 pediatric centers. Associations between DKS score (number of correct answers), glycated hemoglobin (HbA1c) and sociofamilial characteristics were assessed., Results: DKS score increased with age, and was higher in girls than in boys and in mothers than in fathers; it correlated strongly between adolescents and their own parents; it was higher when adolescents had previously participated in diabetes camp and when parents had higher academic levels. HbA1c decreased significantly with parents' higher DKS score and academic level, and when both parents lived together. Mean adolescent DKS score was significantly higher in patients with HbA1c below 8% or 8.5% than for patients with HbA1c above these thresholds., Conclusion: A large survey in T1D children and adolescents and their parents showed associations between DKS and glycemic control, and the major role of sociofamilial factors., (© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Objectives: To further describe the changes in insulin therapy regimens and hemoglobin A1c (HbA1c) in children and adolescents with type 1 diabetes, and their associations with diabetes knowledge and quality of life., Research Design and Methods: The study included 4293 children and adolescents (12.9 ± 2.6 yr, diabetes >1 yr) attending AJD (Aide aux Jeunes Diabétiques) summer camps between 2009 and 2014. The distribution of insulin regimens and associations between HbA1c, therapeutic regimens, diabetes knowledge (AJD questionnaire), and Quality of Life (Ingersoll et Marrero, Hvidoere Study Group short version) were assessed., Results: The percentage of youth treated with insulin pumps increased up to about 45%, basal bolus stabilized around 40%, and other regimens decreased majorly. HbA1c was higher with premixed insulins only regimens (9.05 ± 2.43%), but there was no difference between pump (8.12 ± 1.09%), basal bolus (8.32 ± 1.33%) and two to three injections (8.18 ± 1.28%). Mean HbA1c decreased by 0.014% per year. The percentage of HbA1c <7.5% increased by 1.5% per year, and the percentages of HbA1c >9% or >10% decreased by 4 and 5.5%, changes being greater with the pump. HbA1c was weakly associated with diabetes knowledge, and strongly with general health perception and perception about diabetes., Conclusion: The percentage of children and adolescents with the highest risk of complications decreased markedly. The distribution of HbA1c better depicts the glycemic control in a population than the mean or the percentage of patients reaching the target (7.5%). HbA1c was more strongly associated with general health perception than with therapeutic regimens and diabetes knowledge., (© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Objective: To describe the changes in insulin therapy regimens of children and adolescents with type 1 diabetes over 10 yr and their correlation with hemoglobin A1c (HbA1c)., Research Design and Methods: The study included 7206 children and adolescents (age 12.8 ± 2.7 yr, more than 1 yr of diabetes duration) admitted in summer camps between 1998 and 2007 (707-896/yr). Based on injection times (breakfast, lunch, afternoon, dinner, bedtime) and insulin types (short, long and premixed; human or analog), 786 different therapeutic combinations were classified in six main types of regimens. The distribution of the different regimens and their correlation with HbA1c were evaluated as a function of year and age., Results: Over 10 yr, basal bolus increased from 13 to 52% and the pump from <1 to 13%, regimens with two to three injections per day decreased from 50 to 25%, those with only premixed insulins from 33 to 7%, and diverse regimens from 9 to 1%. HbA1c was significantly higher with premixed insulin only, but there were no differences between the other regimens throughout the follow-up. Mean yearly HbA1c (8.21-8.45%) did not show any significant decrease, but the percentage of patients with HbA1c > 9 and 10% decreased significantly, in those treated with two to three injections and the pump, not with basal bolus or premixed only regimens., Conclusion: A major trend in intensifying insulin treatment in children and adolescents with type 1 diabetes was accompanied by modest improvements in HbA1c. No insulin regimen has shown any better results, except over premixed insulins., (© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Objectives: This study aimed to evaluate the frequency of diabetic ketoacidosis (DKA) and its associated factors at the diagnosis of type 1 diabetes (T1D) in French children and adolescents prior to launching a public-health campaign of information to prevent DKA., Patients and Methods: Over a 1-year period, 1299 youngsters (aged < 15 years) were diagnosed with T1D at 146 paediatric centres in all regions of France. Age, gender, duration of symptoms, patient's pathway to diagnosis, clinical and biological signs, and family history of T1D were collected for each newly diagnosed patient. DKA was defined as pH < 7.30 or bicarbonate < 15 mmol/L, and severe DKA as pH < 7.10 or bicarbonate < 5 mmol/L., Results: At the time of diagnosis, 26% of the children were aged 0-5 years, 34% were 5-10 years and 40% were 10-15 years. The overall prevalence of DKA was 43.9% (0-5 years: 54.2%; 5-10 years: 43.4%; and 10-15 years: 37.1%) and 14.8% for severe DKA (0-5 years: 16.6%; 5-10 years: 14.4%; and 10-15 years: 13.9%; < 2 years: 25.3%). Severe DKA was more frequent when the child was hospitalized at the family's behest (26.6%) than when referred by a general practitioner (7.6%) or paediatrician (5.1%; 30.6%, 53.7% and 9.2%, respectively, by patients' age group). The frequency of DKA decreased to 20.1% (severe DKA: 4.4%) in families with a history of T1D. Multivariate analysis showed that age, pathway to diagnosis, duration of polyuria/polydipsia (< 1 week) and family history of T1D were associated with the presence of DKA, while pathway to diagnosis and family history of T1D were associated with severe DKA., Conclusion: DKA at the time of T1D diagnosis in children and adolescents is frequent and often severe. Patients' age, pathway to hospitalization and family history of diabetes were the main factors associated with DKA. These data suggest that a public-health campaign to prevent DKA at diagnosis can help reduce the frequency of DKA and also provide baseline data for evaluating the efficacy of such a campaign., (Copyright © 2014. Published by Elsevier Masson SAS.)

Objective: Carbohydrate counting is the most difficult component of functional insulin therapy. We thus designed a tool to facilitate carbohydrate counting of meals., Research Design and Methods: The tool consists of an illustrated directory (16 x 10 cm, 119 pages) presenting 389 pictures of food, classified in 12 categories (breads, fruits, vegetables, etc.). For each photo, the name and mode of preparation of the foods are given, with the weight of the illustrated portion and its carbohydrate content as a multiple of 5 g. During the first phase of the study (3 days a week for 12 weeks), twelve patients with type 1 diabetes completed a precise food diary using a list and weight of all consumed foods. We were thus able to determine, for each of three meals (breakfast, lunch and dinner), the variability of their carbohydrate content. During the second phase of the study (2 weeks), the patients were given the possibility of using the illustrated food directory. We asked them first to estimate, from the photos, the global carbohydrate content of their meals, and then to weigh each food. This allowed us to calculate the true carbohydrate content of the meals from nutritional tables., Results: During the first phase, the carbohydrate contents of breakfast, lunch and dinner were 67 +/- 29, 72 +/- 30 and 74 +/- 30 g, respectively (mean +/- SD, n = 12). For a given patient, the variability in the carbohydrate content of each meal was expressed by its standard deviation (SD). For the 12 patients, this variability was 18+/-+ 8, 25+/-+ 8 and 27+/-+ 11 g, respectively, for breakfast, lunch and dinner, and represented on the average about one-quarter of the total carbohydrate content. During the second phase, carbohydrate content, estimated by the patients using the illustrated food directory, correlated well with the retrospective evaluation based on nutritional tables (y = 0.95 x + 5 g, r2 = 0.8 ; n = 12, 235 meals)., Conclusion: This new illustrated food repertory allows accurate evaluation of the highly variable carbohydrate content of meals, and could thus facilitate functional insulin therapy.

Background: Diabetic type 1 patients are often advised to use dose adjustment guidelines to calculate their doses of insulin. Conventional methods of measuring patients' adherence are not applicable to these cases, because insulin doses are not determined in advance. We propose a method and a number of indicators to measure patients' conformance to these insulin dosing guidelines., Methods: We used a database of logbooks of type 1 diabetic patients who participated in a summer camp. Patients used a guideline to calculate the doses of insulin lispro and glargine four times a day, and registered their injected doses in the database. We implemented the guideline in a computer system to calculate recommended doses. We then compared injected and recommended doses by using five indicators that we designed for this purpose: absolute agreement (AA): the two doses are the same; relative agreement (RA): there is a slight difference between them; extreme disagreement (ED): the administered and recommended doses are merely opposite; Under-treatment (UT) and over-treatment (OT): the injected dose is not enough or too high, respectively. We used weighted linear regression model to study the evolution of these indicators over time., Results: We analyzed 1656 insulin doses injected by 28 patients during a three weeks camp. Overall indicator rates were AA = 45%, RA = 30%, ED = 2%, UT = 26% and OT = 30%. The highest rate of absolute agreement is obtained for insulin glargine (AA = 70%). One patient with alarming behavior (AA = 29%, RA = 24% and ED = 8%) was detected. The monitoring of these indicators over time revealed a crescendo curve of adherence rate which fitted well in a weighted linear model (slope = 0.85, significance = 0.002). This shows an improvement in the quality of therapeutic decision-making of patients during the camp., Conclusion: Our method allowed the measurement of patients' adherence to their insulin adjustment guidelines. The indicators that we introduced were capable of providing quantitative data on the quality of patients' decision-making for the studied population as a whole, for each individual patient, for all injections, and for each time of injection separately. They can be implemented in monitoring systems to detect non-adherent patients.

Over the past decade, several continuous glucose monitoring systems have been developed, representing remarkable technological achievements. Most of the systems monitor glucose invasively in the subcutaneous tissue. It is important to realize that there are discrepancies between blood and interstitial glucose concentration, which (1) may impact the quality of the system calibration and thereby the accuracy of the data, (2) may jeopardize the specificity and the sensitivity of hypoglycaemic alarms based on these systems and (3) must be considered in the design of closed-loop insulin delivery systems. The aim of this review is to make the point that the challenge of developing a continuous glucose monitoring system is not only technological, but must also take into account the physiology of glucose in alternate sites where it is sensed.

Background: Day-to-day glucose variability may cause difficulty for patients trying to adjust their insulin dosages and for healthcare providers when they have to make recommendations. The aim of this research was to evaluate the frequency of high variability in a population of diabetic children and adolescents attending summer camp., Methods and Results: The mean of the daily differences (MODD) in glucose concentrations was calculated from continuous glucose monitoring (CGM) over five consecutive days in 6 diabetic patients. This index was correlated to the MODD calculated from pre-meal and bedtime blood glucose (BG) measurements (r=0.87). We used the MODD calculated on these four BG measurements for five consecutive days to evaluate day-to-day glucose variability in 100 young diabetic patients treated with glargine and ultrarapid analogue insulin. Only one child had a MODD value lower than 36mg/dl, considered a threshold for high day-to-day variability, and 94 children had a MODD value higher than 45mg/dl. The median value was 78mg/dl. The expected positive correlation between the MODD and its standard deviation (r=0.32, P<0.01) suggested that the greater the day-to-day variability, the more variable the variability across five consecutive days., Conclusions: The estimation of MODD from four pre-meal BG values correlated to that from CGM, and may represent a simple index of day-to-day glycaemic variability. High day-to-day glucose variability in glucose profile is frequently observed in diabetic children attending summer camp.

Background: Insulin treated diabetic patients often do not adjust their insulin doses. We developed a method to provide a quantitative and qualitative assessment of this behavior., Methods: Fourteen patients provided logbook pages of their self-monitoring of blood glucose (SMBG) data and insulin doses. We compared the actual decisions of patients in real-life to what they would decide on the same SMBG, as an a posteriori exercise. We also compared these decisions and those proposed by 6 diabetologists on the same sets of data to the recommendations made by HumaLink, an automated insulin dosage system., Results: 1) Patients in real-life modified their insulin doses least often. However, given a chance to make these decisions a posteriori, they modified their insulin doses more often. HumaLink proposed changes even more often, and diabetologists were the most aggressive in changing insulin doses. 2) The decisions proposed by the patients in real-life or a posteriori and by the diabetologists were compared to the recommendations made by HumaLink, using a decisions analysis grid (DAG). For these three groups, full disagreement with HumaLink (patient or physician increases while HumaLink decreases and the opposite) was observed for less than 5% of the cases. 3) By comparison to HumaLink, patient decisions seemed guided by the desire to avoid hypoglycemia. By contrast, decisions by diabetologists seemed often to be guided by the desire to avoid hyperglycemia., Conclusion: These methods provide an objective evaluation of insulin dose adjustments by patients with diabetes and may be useful to assess the effectiveness of educational programs.

This paper describes the current approaches towards the development of continuous glucose monitoring system, in which glucose is measured either in blood or in the subcutaneous tissue. These systems may be used as a glycemic holter, or to display continuously the changes in glucose level, to trigger an alarm in case of hypoglycemia, or of risk of hypoglycemia, or finally to pave the way to the development of an artificial beta cell.

Due to the lag between sugar intake and the beginning of recovery from hypoglycemia, it is necessary to intervene in an anticipatory way if one wants to prevent, not only detect, hypoglycemia. This article presents the principle of a hypoglycemia prevention system based on risk assessment. The risk situation can be defined as the moment when the system estimates that the glucose concentration is expected to reach a hypoglycemia threshold in less than a given time (e.g., 20 min). Since there are well-known discrepancies between blood and interstitial glucose concentrations, the aim of this experimental study performed in nondiabetic rats was first to validate this strategy, and second to determine whether it can work when the glucose concentration is estimated by a glucose sensor in subcutaneous tissue rather than in blood. We used a model of controlled decrease in blood glucose concentration. A glucose infusion, the profile of which mimicked the appearance of glucose from an intragastric load, was administered either when hypoglycemia was detected or on the basis of risk recognition. Despite the lag between the beginning of the load and that of the increase in blood glucose concentration, which was in all experiments 15-20 min, hypoglycemia was fully prevented without overshoot hyperglycemia in the groups of rats in which the glucose load was started when the hypoglycemia risk was detected, on the basis of either blood or interstitial glucose concentration. This was, of course, not the case when the same glucose load was infused at the detection of the hypoglycemia threshold.

The calibration of a continuous glucose monitoring system, i.e. the transformation of the signal I(t) generated by the glucose sensor at time (t) into an estimation of glucose concentration G(t), represents a key issue. The two-point calibration procedure consists of the determination of a sensor sensitivity S and of a background current I(o) by plotting two values of the sensor signal versus the concomitant blood glucose concentrations. The estimation of G(t) is subsequently given by G(t) = (I(t)-I(o))/S. A glucose sensor was implanted in the subcutaneous tissue of nine type 1 diabetic patients during 3 (n = 2) and 7 days (n = 7). For each individual trial, S and I(o) were determined by taking into account the values of two sets of sensor output and blood glucose concentration distant by at least 1 h, the procedure being repeated for each consecutive set of values. S and I(o) were found to be negatively correlated, the value of I(o) being sometimes negative. Theoretical analysis demonstrates that this phenomenon can be explained by the effect of measurement uncertainties on the determination of capillary glucose concentration and of sensor output.

Unlabelled: Calibration, i.e. the transformation in real time of the signal I(t) generated by the glucose sensor at time t into an estimation of glucose concentration G(t), represents a key issue for the development of a continuous glucose monitoring system., Objective: To compare two calibration procedures. In the one-point calibration, which assumes that I(o) is negligible, S is simply determined as the ratio I/G, and G(t) = I(t)/S. The two-point calibration consists in the determination of a sensor sensitivity S and of a background current I(o) by plotting two values of the sensor signal versus the concomitant blood glucose concentrations. The subsequent estimation of G(t) is given by G(t) = (I(t)-I(o))/S., Research Design and Methods: A glucose sensor was implanted in the abdominal subcutaneous tissue of nine type 1 diabetic patients during 3 (n = 2) and 7 days (n = 7). The one-point calibration was performed a posteriori either once per day before breakfast, or twice per day before breakfast and dinner, or three times per day before each meal. The two-point calibration was performed each morning during breakfast., Results: The percentages of points present in zones A and B of the Clarke Error Grid were significantly higher when the system was calibrated using the one-point calibration. Use of two one-point calibrations per day before meals was virtually as accurate as three one-point calibrations., Conclusion: This study demonstrates the feasibility of a simple method for calibrating a continuous glucose monitoring system.