Impact of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Randomised Multicentre Study.

INTRODUCTION: Telemonitoring in type 2 diabetes (T2D) is mainly based on glucose monitoring. A new type of connected device which routinely gathers data on weight, physical activity and food intake could improve patients' diabetes control. The main aim of this study was to assess the efficacy of an at-home interventional programme incorporating such devices and lifestyle education software on diabetes control, i.e., change in HbA1c, compared to standard care. METHODS: This multicentre study randomly assigned 282 people with T2D to either a telemonitoring group (TMG) or a control group (CG) for a 1-year intervention period. While routine follow-up was maintained in the CG, TMG subjects were provided with interactive lifestyle educational software (with artificial intelligence algorithms) and connected objects (blood glucose meters, scales and actimeters) for use in their own homes and were remotely monitored by their diabetologists. Changes in HbA1c were compared between groups using a mixed linear model. RESULTS: The mean HbA1c dropped from 7.8 ± 0.8% (62 mmol/mol) to 7.4 ± 1.0% (57 mmol/mol) in the TMG and from 7.8 ± 0.8% (62 mmol/mol) to 7.6 ± 1.0% (60 mmol/mol) in the CG, resulting in an intergroup difference of - 0.16 (p = 0.06) in favour of TMG, after adjustment for confounding factors. Within TMG, the decrease in HbA1c was greater in frequent users: - 0.23% (p = 0.03) in the case of connections to telemonitoring synthesis above the median and - 0.21% (p = 0.05) in the case of connections to tele-education software above the median compared to the CG. Significant weight loss was observed in the TMG but only in women (p = 0.01). FINDINGS: The EDUC@DOM telemonitoring and tele-education device did not highlight a significant decrease in HbA1c levels compared to routine management although a slight, albeit significant improvement in glycaemic control was observed in the frequent user subgroup as well as significant weight loss but only in women. A high level of satisfaction with the connected device was recorded amongst all participants. TRIAL REGISTRATION: This trial was registered in the Clinical Trials Database on September 27, 2013, under no. NCT01955031 and bears ID-RCB number 2013-A00391-44.

No more hypoglycaemia on days with physical activity and unrestricted diet when using a closed-loop system for 12 weeks: A post hoc secondary analysis of the multicentre, randomized controlled Diabeloop WP7 trial.

A post hoc analysis of the Diabeloop WP7 multicentre, randomized controlled trial was performed to investigate the efficacy of the Diabeloop Generation-1 (DBLG1) closed-loop system in controlling the hypoglycaemia induced by physical activity (PA) in real-life conditions. Glycaemic outcomes were compared between days with and without PA in 56 patients with type 1 diabetes (T1D) using DBLG1 for 12 weeks. After the patient announces a PA, DBLG1 reduces insulin delivery and, if necessary, calculates the amount of preventive carbohydrates (CHO). Daily time spent in the interstitial glucose range less than 70 mg/dL was not significantly different between days with and without PA (2.0% ± 1.5% vs. 2.2% ± 1.1%), regardless of the intensity or duration of the PA. Preventive CHO intake recommended by the system was significantly higher in days with PA (41.1 ± 35.5 vs. 21.8 ± 28.5 g/day; P < .0001), and insulin delivery was significantly lower (31.5 ± 10.5 vs. 34.0 ± 10.5 U/day; P < .0001). The time spent in hyperglycaemia and the glycaemic variation coefficient increased significantly on days with PA. In real-life conditions, the use of DBLG1 avoids PA-induced hypoglycaemia. Insulin adjustments and preventive CHO recommendation may explain this therapeutic benefit.

Medical therapy in patients with endogenous hypoglycaemia: Is euglycaemia achievable?

CONTEXT: While the only curative treatment for patients with endogenous hypoglycaemia related to inappropriate insulin or to insulin growth factor 2 (IGF2) secretion is surgery, medical treatment to normalize plasma glucose levels can be useful. OBJECTIVE: The aim of this prospective single centre study was to assess whether patients with endogenous hypoglycaemia, considered euglycaemic with medical treatments, experienced asymptomatic hypo- or hyperglycaemic excursions. PATIENTS AND METHODS: All patients with endogenous hypoglycaemia related to inappropriate insulin or to IGF2 secretion between 2012 and 2016 and considered normoglycaemic with medical treatment (absence of clinical hypoglycaemia and self-monitoring blood glucose in the normal range) were enroled and underwent a six-day continuous glucose monitoring (CGM) recording. RESULTS: Twenty-seven patients (inappropriate insulin secretion n = 25 and IGF2 secretion n = 2), treated with diazoxide (n = 16), somatostatin analogues (n = 7), glucocorticoids (n = 3) or a combination of these treatments (n = 1) were enroled. Twenty-five CGMs were analysed. CGM confirmed normoglycaemia in 11/25 patients (44%). Hypoglycaemias below 0.60 g/L were present in seven patients (28%) and were associated with hyperglycaemic excursions above 1.40 g/L in five patients. Seven patients (28%) had only hyperglycaemic excursions. Based on these results, treatment was modified in 14 patients (56%). CONCLUSION: Despite the disappearance of hypoglycaemia-related clinical symptoms and normalization of blood glucose self-monitoring data, 56% of the patients with endogenous hypoglycaemia treated with medical therapy experienced asymptomatic hypo- and/or hyperglycaemia. Continuous glucose monitoring could be a useful approach to reveal and prevent hypo- or hyperglycaemic excursions.

The Electronic Pharmaceutical Record: A new method for medication reconciliation.

RATIONALE, AIM, AND OBJECTIVE: There are several ways to establish an accurate medication list in the hospital admission medication reconciliation (MedRec). The challenge for MedRec lies in the availability, reliability, and completeness of the data used. In France, the Electronic Pharmaceutical Record (ePR) was developed to register each medication taken by ambulatory patients, primarily to make dispensation in community pharmacies safe. We evaluated the suitability of this tool in the MedRec when patients were admitted to the hospital. METHOD: We conducted a 6-month pilot study of 249 MedRec files from a hospital diabetology department. The analysis was supplemented by the ePR for any patient for whom this information was recorded. The study evaluated the ePR as a new MedRec tool, as well as the clinical impact (CI) of the new data collected. RESULTS: The ePR was contributory for 28% of the patients. Discrepancies were associated with polypharmacy, most of which had a CI = 1. Medication omission was the most frequently found discrepancy (72%), but self-medication (8%) and lack of medication adherence (9%) were also observed. CONCLUSION: This tool provided added value for reconciliation, as it quickly identifies regular medications, adherence, and self-medication behaviour. The ePR is essential for conducting a thorough MedRec.

DIABSAT Telemedicine Itinerant Screening of Chronic Complications of Diabetes Using a Satellite.

BACKGROUND: Health authorities recommend regular screening for the chronic complications of diabetes. The ENTRED * survey results show that insufficient screening is undertaken. The DIABSAT † program aims to improve care for diabetes patients in rural areas of the Midi-Pyrénées region, telemonitoring complications of diabetes through an itinerant screening service. METHODS: A vehicle was equipped with a satellite dish and medical equipment for screening ophthalmological, renal, vascular, and neuropathic damage and assessing the level of risk of diabetic foot ulceration. Onboard, a nurse performs some or all of the tests on patients who have had no diabetes review for over a year. The data are entered into a computer and transmitted by satellite for interpretation by designated specialists. The results are sent to patients, general practitioners (GPs), and diabetologists. RESULTS: Two hundred twenty-eight screening days were held in six departments of the Midi-Pyrénées between 2010 and 2013. 1,545 patients were screened: mean age 70.7 years, 55.8% men. 93.4% diagnosed with type 2 diabetes, mean duration 11.7 years. Recruitment was chiefly by health professionals (55%). 17-32% of tests detected pathologies: 18.7% diabetic retinopathy, 31.9% microalbuminuria, 17.2% lower limb arteriopathy, 28.3% peripheral neuropathy, and 28.2% high risk of foot ulceration (grade 2: 20.6% and grade 3: 7.6%). CONCLUSION: The large number of patients screened and the high rate of pathological results found, confirm telemonitoring viability and relevance. DIABSAT, a primary resource for healthcare professionals, improves healthcare access through its innovative organization and use of satellite technology.

ß-cell pancreatic dysfunction plays a role in hyperglycemic peaks observed after gastric bypass surgery of obese patients.

BACKGROUND: Early and intense hyperglycemic peaks are observed after Roux-en-Y gastric bypass (RYGB). OBJECTIVES: The aim of this observational study was to compare the ß-cell pancreatic function of patients with (PEAK) and without hyperglycemic peaks (NOPEAK). SETTING: Referral bariatric surgery center. METHODS: Insulin secretion rate, clearance, and sensitivity and ß-cell and rate sensitivities were computed after a 75-g oral glucose tolerance test in 42 patients who underwent RYGB. RESULTS: PEAK patients (n = 18; 30-min glycemia>10.4 mmol/L) did not differ from NOPEAK patients (n = 24) in their presurgery or weight loss characteristics. PEAK patients had significantly higher plasma concentrations of glucose and C-peptide than did NOPEAK patients, whereas insulin and glucagon-like peptide-1 concentrations did not differ. The insulin secretion rate and whole-body insulin clearance (208%) were significantly greater, but insulin sensitivity was significantly less (48%) in PEAK patients. Insulin secretion normalized to plasma glucose was significantly lower in PEAK patients, and the disposition index was reduced (35% to 41% of the values in NOPEAK patients). CONCLUSION: We conclude that RYGB reveals a series of dysfunctions leading to hyperglycemia in a subset of patients. In PEAK patients, an insufficient adaptation of ß-cell function to glycemia, an increased insulin clearance, and a decreased insulin sensitivity cumulated to contribute to hyperglycemic peaks.

Post-prandial hypoglycemia results from a non-glucose-dependent inappropriate insulin secretion in Roux-en-Y gastric bypassed patients.

BACKGROUND: After Roux-en-Y gastric bypass (RYGB), hypoglycemia can occur and be associated with adverse events such as intense malaise and impaired quality of life. OBJECTIVE: To compare insulin secretion, sensitivity, and clearance between two groups of patients, with or without hypoglycemia, after an oral glucose tolerance test (OGTT 75-g), and also to compare real-life glucose profiles within these two groups. SETTING: Bariatric surgery referral center. METHODS: This study involves a prospective cohort of 46 consecutive patients who complained of malaise compatible with hypoglycemia after RYGB, in whom an OGTT 75-g was performed. A plasma glucose value of lower than 2.8 mmol/L (50 mg/dl) between 90 and 120 min after the load was considered to be a significant hypoglycemia. The main outcome measures were insulin sensitivity, beta-cell function, and glycemic profiles during the test. Glucose parameters were also evaluated by continuous glucose monitoring (CGM) in a real-life setting in 43 patients. RESULTS: Twenty-five patients had plasma glucose that was lower than 2.8 mmol/L between 90 and 120 from the load (HYPO group). Twenty-one had plasma glucose that was higher than 2.8 mmol/L (NONHYPO group). The HYPO patients were younger, had lost more weight after RYGB, were less frequently diabetic before surgery, and displayed higher early insulin secretion rates compared with the NONHYPO patients after the 75-g OGTT, and they had lower late insulin secretion rates. The HYPO patients had lower interstitial glucose values in real life, which suggests that a continuum exists between observations with an oral glucose load and real-life interstitial glucose concentrations. CONCLUSIONS: This study suggests that HYPO patients after RYGB display an early increased insulin secretion rate when tested with an OGTT. CGM shows that HYPO patients spend more time below 3.3 mmol/L when compared with NONHYPO patients. This phenotype of patients should be monitored carefully after RYGB.

Glucose Profiles in Pregnant Women After a Gastric Bypass : Findings from Continuous Glucose Monitoring.

BACKGROUND: The diagnosis of gestational diabetes mellitus (GDM) usually requires an oral glucose tolerance test, but this procedure seems inappropriate after gastric bypass surgery (Roux-en-Y gastric bypass (RYGB)) due to specific altered glycemic responses. We aimed here at describing continuous glucose monitoring (CGM) profile of pregnant women after RYGB. METHODS: CGM was performed in 35 consecutive pregnant women after RYGB at 26.2 ± 5 weeks of gestation. RESULTS: After RYGB, pregnant women display high postprandial interstitial glucose (IG) peaks and low IG before and 2 h after meals. The postprandial IG peak is reached early, within 54 ± 9 min. The maximum IG values reach 205 mg/dl, and the percentage of time above 140 mg/dl (6.6 ± 7 %) is similar to what is described in GDM women. CONCLUSIONS: This study is the first to describe CGM profile in pregnant women after RYGB. CGM features are similar to those of non-pregnant post-RYGB patients, characterized by wide and rapid changes in postprandial IG, and high exposure to hyperglycemia. The exposure to hyperglycemia is similar to what is reported in GDM although the time to postprandial peak is shorter. CGM could be an additional useful approach to screen for glucose intolerance during pregnancy after RYGB.

Impact of Carbohydrate Content and Glycemic Load on Postprandial Glucose After Roux-en-Y Gastric Bypass.

BACKGROUND: Abnormal glucose profiles have been described after Roux-en-Y gastric bypass (RYGB) with intense postprandial hyperglycemic peaks in some but not all the patients. The underlying mechanisms of these anomalies are not totally understood. OBJECTIVE: The aim of this study is to determine whether or not the composition of the meal impacts the existence and maximum interstitial glucose (IG) concentration, measured under real-life conditions. DESIGN: Retrospective cohort. SETTING: Referral bariatric surgery left. METHODS: Continuous glucose monitoring (CGM) and meal composition were recorded for at least 3 days on an outpatient basis in 56 patients after RYGB. The presence of postprandial peaks defined by IG above 140 mg/dl, the maximum postprandial IG, the carbohydrate content, and the glycemic load of the meals were analyzed. RESULTS: Thirty-two patients had a hyperglycemic peak (PEAK), and 24 did not (NO PEAK). The average max IG was 159.6 ± 33.0 mg/dl in PEAK individuals and 111.8 ± 13.0 mg/dl in NO PEAK. Age was significantly higher in PEAK, but no other parameter was different between the two groups, including meal composition. In the PEAK patients, in multivariate analyses, carbohydrate content in model one and glucose load in model two explained respectively 50 and 26 % of maximum IG variance. For each gram of ingested carbohydrates, interstitial glucose increased by 1.68 mg/dl. CONCLUSIONS: Following a gastric bypass, under real-life conditions, irrespective of the carbohydrate content of the meal, some patients develop postprandial hyperglycemic peaks, whereas others do not. In patients with postprandial hyperglycemic peaks, the maximum IG depends on the carbohydrate content of the meal.

Effect of Nutritional Intervention on Food Choices of French Students in Middle School Cafeterias, Using an Interactive Educational Software Program (Nutri-Advice).

OBJECTIVE: To evaluate the impact of interactive Nutri-Advice kiosks on children's nutritional skills and their ability to apply it to food choices in a middle school cafeteria menu (food choice competencies). DESIGN: Quasi-experimental design; pre/post-test. SETTING: Freestanding interactive computer terminals (kiosks) were installed in three middle schools in Toulouse, France. PARTICIPANTS: A total of 580 children were enrolled into the study (mean age, 13 ± 1 years). INTERVENTION: Each child's physiological profile was stored in a personal barcode card. During 1 school year, once a day, each child could access the kiosk with this card, trying to find the most balanced meal according to his or her profile and the food available on the cafeteria menu. MAIN OUTCOME MEASURES: Children's food choice competency changes and body mass index z-score were evaluated. ANALYSIS: Significance of change in food choice competencies (postintervention vs baseline) was examined using paired t test. RESULTS: Across the study, children chose significantly less cheese and pastry or desserts, and significantly more starchy food and dairy, and tended to choose fruits and vegetables more often. Body mass index z-score decreased significantly during the period. CONCLUSIONS AND IMPLICATIONS: Personalized nutrition counseling through an interactive device has the potential to improve the food choice competencies of children.

Increased risk of OGTT-induced hypoglycemia after gastric bypass in severely obese patients with normal glucose tolerance.

BACKGROUND: Hypoglycemic episodes are described after bariatric surgery. OBJECTIVE: To report the prevalence of hypoglycemia after a 75 g oral glucose load (OGTT) after Roux-en-Y gastric bypass (RYGB) and adjustable gastric banding (LAGB), and to identify predicting factors. SETTING: Bariatric surgery referral center. METHODS: Prospective cohort of 351 consecutive patients before and 12 months after bariatric surgery, on whom an OGTT was performed. The main outcome measure was postchallenge hypoglycemia (PCHy), defined as a 120 minute plasma glucose value<2.8 mmol/L (50.4 mg/dL). RESULTS: Only patients with an RYGB presented with PCHy. It occurred in 23 patients or a prevalence of 10.4% after an RYGB. The OR was 25.5 (95% CI 3.4-191; P<.001) compared with before surgery. Patients with PCHy after surgery had a lower glycated hemoglobin (HbA1c), and a lower 2-hour postchallenge value before surgery. Before surgery, patients with normal glucose tolerance had an increased risk of PCHy after surgery (OR 8.6, 95% CI 2.0-37.6; P< .001). CONCLUSIONS: The prevalence of OGTT-induced hypoglycemia is increased 25.5 times, 12 months after an RYGB. This is not observed after a gastric banding.

Relationship between markers of insulin resistance, markers of adiposity, HbA1c, and cognitive functions in a middle-aged population-based sample: the MONA LISA study.

OBJECTIVE: To determine the relationship between markers of insulin resistance (fasting insulin and homeostasis model assessment of insulin resistance), markers of adiposity (BMI, waist circumference, and body fat), HbA1c, and cognitive performances in a middle-aged population-based sample free of diabetes. RESEARCH DESIGN AND METHODS: Our study sample consisted of 1,172 people aged 35-64 years (49% women), free of diabetes, and recruited between 2005 and 2007 in the MONA LISA survey. Cognitive functions (memory, attention, and processing speed) were evaluated by neuropsychological tests: word-list learning test, digit symbol substitution test (DSST), word fluency test, and Stroop Test. Multiple logistic regressions were used to estimate the relationship between cognitive performance and metabolic markers. We serially adjusted for age, sex, education, and occupational status (model A), additionally for income, smoking, alcohol consumption, sedentarity, and psychotropic substance use (model B), and finally, included variables linked to the metabolic syndrome (hypertension, dyslipidemia, vascular disease, and C-reactive protein) and depression (model C). RESULTS: Elevated markers of adiposity were associated with poor cognitive performance in tests evaluating processing speed. The probability of being in the lowest quartile of each test was nearly doubled for participants in the upper quartile of BMI, compared with those in the lowest one [BMI, adjusted odds ratio (OR) 2.18, P = 0.003 (DSST), and OR 2.09, P = 0.005 (Stroop Test)]. High HbA1c was associated with poor cognitive performance in DSST (adjusted OR 1.75, P = 0.037). Waist circumference was linked to poor cognitive performance in men but not in women. CONCLUSIONS: Poor cognitive performance is associated with adiposity and hyperglycemia in healthy middle-aged people.

["Local" or "mobile" screening for diabetic retinopathy in general practice by non-mydriatic digital cameras? about the Diabetes Midi-Pyrénées network activity between 2005 and 2010]. / Dépistage "fixe" ou "itinérant" de la rétinopathie diabétique par rétinographe non mydriatique? A propos du bilan d'activité du réseau Diabète Midi-Pyrénées entre 2005 et 2010.

Fundus photographs using non-mydriatic digital cameras for diabetic retinopathy screening have been studied in France during the past 10 years. Nevertheless, the different screening modalities have not been compared. The main goal of this study was to compare patient recruitment with two different screening modalities, and secondarily to compare diagnostic effectiveness and cost. A retrospective study analyzed data from the Diabetes Midi Pyrenees Network in 2005 and between 2006 and 2010. In 2005, a vehicle with digital camera traveled through a rural department in order to screen diabetic patients whose last fundus examination was performed greater than 1 year previously. Between 2006 and 2010, general practitioners sent their diabetic patients whose last fundus examination was performed greater than 1 year previously to a "local" screening site. In the two cases, fundus photographs were made by trained operator at screening site and analyzed by an ophthalmologist. The "mobile" screening recruited 698 patients, and the "local" screening 345 patients. Patients recruited by "mobile" screening were older than those recruited by "local" screening. They were preferentially men and suffered from diabetes from far longer The diagnostic performance of "local" screening was 26.8%, and it was 28.6% for "mobile" screening (p = 0.47). The cost of screening was higher for "mobile" screening: 116 Euro against 61 Euro for "local" screening. "Mobile" screening could allow more patient recruitment than "local" screening when geographic and demographic constraints are more important.

High glycemic variability assessed by continuous glucose monitoring after surgical treatment of obesity by gastric bypass.

BACKGROUND: Obesity surgery elicits complex changes in glucose metabolism that are difficult to observe with discontinuous glucose measurements. We aimed to evaluate glucose variability after gastric bypass by continuous glucose monitoring (CGM) in a real-life setting. METHODS: CGM was performed for 4.2 ± 1.3 days in three groups of 10 subjects each: patients who had undergone gastric bypass and who were referred for postprandial symptoms compatible with mild hypoglycemia, nonoperated diabetes controls, and healthy controls. RESULTS: The maximum interstitial glucose (IG), SD of IG values, and mean amplitude of glucose excursions (MAGE) were significantly higher in operated patients and in diabetes controls than in healthy controls. The time to the postprandial peak IG was significantly shorter in operated patients (42.8 ± 6.0 min) than in diabetes controls (82.2 ± 11.1 min, P = 0.0002), as were the rates of glucose increase to the peak (2.4 ± 1.6 vs. 1.2 ± 0.3 mg/mL/min; P = 0.041). True hypoglycemia (glucose <60 mg/dL) was rare: the symptoms were probably more related to the speed of IG decrease than to the glucose level achieved. Half of the operated patients, mostly those with a diabetes background before surgery, had postprandial glucose concentrations above 200 mg/dL (maximum IG, 306 ± 59 mg/dL), in contrast to the normal glucose concentrations in the fasting state and 2 h postmeal. CONCLUSIONS: Glucose variability is exaggerated after gastric bypass, combining unusually high and early hyperglycemic peaks and rapid IG decreases. This might account for postprandial symptoms mimicking hypoglycemia but often seen without true hypoglycemia. Early postprandial hyperglycemia might be underestimated if glucose measurements are done 2 h postmeal.

Usefulness of continuous glucose monitoring for the diagnosis of hypoglycemia after a gastric bypass in a patient previously treated for type 2 diabetes.

Hypoglycemia is rare after a gastric bypass and can be taken for a dumping syndrome. There is no report in the literature of the contribution of continuous glucose monitoring to the diagnosis of hypoglycemia in these circumstances. The present case report shows that continuous glucose monitoring can be a useful tool for the diagnosis and the management of such episodes. Continuous glucose monitoring revealed hypoglycemic episodes in free living circumstances that were not present during 72-h fasting. These episodes followed wide hyperglycemic swings. No such episode resumed over 8 months after specific dietary advices and treatment by 50 mg TID of acarbose. Because hypoglycemia can be difficult to diagnose from dumping syndrome, continuous glucose monitoring is a very useful tool revealing the episodes in free living circumstances and can be used to monitor the treatment success.

Predictive factors for posttransplant diabetes mellitus within one-year of liver transplantation.

INTRODUCTION: The aims of our single-center study were to identify whether pretransplant diabetes had an impact on patient survival and, secondly, the predictive factors for development of new-onset diabetes mellitus (NODM) (as defined by American Diabetes Association/World Health Organization). PATIENTS AND METHODS: One hundred seventy-nine consecutive adult orthotopic liver-transplant patients were included in this study. Immunosuppression was based on calcineurin inhibitors with steroids, with or without mycophenolate mofetil, and with or without induction therapy. To evaluate the predictive factors for NODM, donor and recipient pre- and posttransplant data were included. RESULTS: At transplantation, 38 patients had diabetes (group I), and the 141 nondiabetic patients constituted group II. In group I, paternal history of diabetes was more frequent (P=0.03), as was length of exposure to smoking (P=0.03), higher pretransplant glycemia (P<0.001), and shorter cold-ischemia (P=0.027) compared with group II. Pretransplant diabetes in group I resulted in a mortality rate of 39.5% at 1 year compared with 19.1% in group II (P=0.009). In group II, in multivariate analysis, independent predictive factors for NODM at M12 were pretransplant glycemia (P=0.037), alcohol-induced end-stage liver disease (P=0.04), and cumulative steroid dose within 1-year posttransplant (P=0.05). CONCLUSION: Of the independent predictive risk factors for NODM, only steroid dose is modifiable, emphasizing the need for individualized immunosuppression.