Vincent Melki

The Diabeo Software Enabling Individualized Insulin Dose Adjustments Combined With Telemedicine Support Improves HbA1c in Poorly Controlled Type 1 Diabetic Patients A 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study)

OBJECTIVE To demonstrate that Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support significantly improves HbA1c in poorly controlled type 1 diabetic patients. RESEARCH DESIGN AND METHODS In a six-month open-label parallel-group, multicenter study, adult patients (n = 180) with type 1 diabetes (>1 year), on a basal-bolus insulin regimen (>6 months), with HbA1c ≥8%, were randomized to usual quarterly follow-up (G1), home use of a smartphone recommending insulin doses with quarterly visits (G2), or use of the smartphone with short teleconsultations every 2 weeks but no visit until point end (G3). RESULTS Six-month mean HbA1c in G3 (8.41 ± 1.04%) was lower than in G1 (9.10 ± 1.16%; P = 0.0019). G2 displayed intermediate results (8.63 ± 1.07%). The Diabeo system gave a 0.91% (0.60; 1.21) improvement in HbA1c over controls and a 0.67% (0.35; 0.99) reduction when used without teleconsultation. There was no difference in the frequency of hypoglycemic episodes or in medical time spent for hospital or telephone consultations. However, patients in G1 and G2 spent nearly 5 h more than G3 patients attending hospital visits. CONCLUSIONS The Diabeo system gives a substantial improvement to metabolic control in chronic, poorly controlled type 1 diabetic patients without requiring more medical time and at a lower overall cost for the patient than usual care.

Improvement of HbA1c and Blood Glucose Stability in IDDM Patients Treated With Lispro Insulin Analog in External Pumps

OBJECTIVE To compare the efficacy of the short-acting insulin analog lispro (LP) with that of regular insulin in IDDM patients treated with an external pump. RESEARCH DESIGN AND METHODS Thirty-nine IDDM patients (age, 39.4 ± 1.5 years; sex ratio, 22M/17W; BMI, 24.4 ± 0.4 kg/m2; diabetes duration, 22.5 ± 1.6 years) who were treated by external pump for 5.1 ± 0.5 years were involved in an open-label, randomized, crossover multicenter study comparing two periods of 3 months of continuous subcutaneous insulin infusion with LP or with Actrapid HM, U-100 (ACT). Boluses were given 0–5 min (LP) or 20–30 min (ACT) before meals. Blood glucose (BG) was monitored before and after the three meals every day. RESULTS The decrease in HbA1c was more pronounced with LP than with ACT (−0.62 ± 0.13 vs. −0.09 ± 0.15%, P = 0.01). BG levels were lower with LP (7.93 ± 0.15 vs. 8.61 ± 0.18 mmol/l, P < 0.0001), particularly postprandial BG levels (8.26 ± 0.19 vs. 9.90 ± 0.20 mmol/l, P < 0.0001). Standard deviations of all the BG values (3.44 ± 0.10 vs. 3.80 ± 0.10 mmol/l, P = 0.0001) and of postprandial BG values (3.58 ± 0.10 vs. 3.84 ± 0.10 mmol/l. P < 0.02) were lower with LP. The rate of hypoglycemic events defined by BG < 3.0 mmol/l did not significantly differ between LP and ACT (7.03 ± 0.94 vs. 7.94 ± 0.88 per month, respectively), but the rate of occurrences of very low BG, defined as BG < 2.0 mmol/l, were significantly reduced with LP (0.05 ± 0.05 vs. 0.47 ± 0.19 per month, P < 0.05). At the end of the study, all but two (95%) of the patients chose LP for the extension phase. CONCLUSIONS When used in external pumps, LP provides better glycemic control and stability than regular insulin and does not increase the frequency of hypoglycemic episodes.

Practical implementation, education and interpretation guidelines for continuous glucose monitoring: A French position statement

The use by diabetes patients of real-time continuous interstitial glucose monitoring (CGM) or the FreeStyle Libre® (FSL) flash glucose monitoring (FGM) system is becoming widespread and has changed diabetic practice. The working group bringing together a number of French experts has proposed the present practical consensus. Training of professionals and patient education are crucial for the success of CGM. Also, institutional recommendations must pay particular attention to the indications for and reimbursement of CGM devices in populations at risk of hypoglycaemia. The rules of good practice for CGM are the precursors of those that need to be enacted, given the oncoming emergence of artificial pancreas devices. It is necessary to have software combining user-friendliness, multiplatform usage and average glucose profile (AGP) presentation, while integrating glucose and insulin data as well as events. Expression of CGM data must strive for standardization that facilitates patient phenotyping and their follow-up, while integrating indicators of variability. The introduction of CGM involves a transformation of treatment support, rendering it longer and more complex as it also includes specific educational and technical dimensions. This complexity must be taken into account in discussions of organization of diabetes care.

Indication, organization, practical implementation and interpretation guidelines for retrospective CGM recording: A French position statement.

AIM The benefits of retrospective continuous glucose monitoring (retroCGM) recording have been widely explored in clinical studies, and many diabetes physicians routinely use this examination. However, the method of interpretation of CGM recordings has never been precisely described. METHOD An expert French panel of physicians met for two days to discuss several aspects of retroCGM use and to produce a position statement. RESULTS The guidelines cover the indications for retroCGM, the general organization and practical implementation of CGM recordings, a description of the different devices available and guidelines for the interpretation of retroCGM recordings. CONCLUSION This consensus document should help clinicians in the proper use of retroCGM.

Preliminary Evaluation of a New Semi-Closed-Loop Insulin Therapy System Over the Prandial Period in Adult Patients With Type 1 Diabetes The WP6.0 Diabeloop Study

Objective: There is room for improvement in the algorithms used in closed-loop insulin therapy during the prandial period. This pilot study evaluated the efficacy and safety of the Diabeloop algorithm (model predictive control type) during the postprandial period. Methods: This 2-center clinical trial compared interstitial glucose levels over two 5-hour periods (with/without the algorithm) following a calibrated lunch. On the control day, the amount of insulin delivered by the pump was determined according to the patient’s usual parameters. On the test day, 50% or 75% of the theoretical bolus required was delivered, while the algorithm, informed of carbohydrate intake, proposed changes to insulin delivery every 15 minutes using modeling to forecast glucose levels. The primary endpoint was percentage of time spent at near normoglycemia (70-180 mg/dl). Results: Twelve patients with type 1 diabetes (9 men, age 35.6 ± 12.7 years, HbA1c 7.3 ± 0.8%) were included. The percentage of time spent in the target range was 84.5 ± 20.8 (test day) versus 69.2 ± 33.9% (control day, P = .11). The percentage of time spent in hypoglycemia < 70 mg/dl was 0.2 ± 0.8 (test) versus 4.4 ± 8.2% (control, P = .18). Interstitial glucose at the end of the test (5 hours) was 127.5 ± 40.1 (test) versus 146 ± 53.5 mg/dl (control, P = .25). The insulin doses did not differ, and no differences were observed between the 50% and 75% boluses. Conclusion: In a semi-closed-loop configuration with manual priming boluses (25% or 50% reduction), the Diabeloop v1 algorithm was as successful as the manual method in determining the prandial bolus, without any exposure to excessive hypoglycemic risk.

Continuous intraperitoneal insulin infusion does not increase the risk of organ-specific autoimmune disease in type 1 diabetic patients: results of a multicentric, comparative study

AIM The purpose of this national multicenter prospective study by the French EVADIAC group was to investigate the possibility that continuous intraperitoneal insulin infusion using an implanted pump (CIpii) increases the risk of autoimmune disease in type 1 diabetic patients as it increased anti-insulin immunogenicity. METHODS Prevalence of clinical (Hashimotos disease, hyperthyroidism, gastric atrophic disease and vitiligo) and subclinical (presence of anti-thyroperoxidase antibodies, anti-intrinsic factor antibodies, abnormal TSH levels) autoimmune diseases was estimated by comparing two groups of patients already treated by either CIpii (n=154) or external pump (CSII) (n=121) for an average of 6 years. Incidence of autoimmune disease was determined by comparing the same measurements one year after inclusion. RESULTS No significant difference was observed for the total prevalence of clinical and subclinical auto-immune thyroid and gastric di-seases (35.6% and 3.2% respectively in the CIpii group versus 40.4% and 2.6% in the CSII group). No significant difference for the incidence of clinical and subclinical auto-immune diseases was observed: 7.2% and 0% in CIpii and 7.3% and 1.7% in CSII. CONCLUSION As previously shown AIA (anti-insulin antibodies) levels were higher in CIpii than in CSII (32.9% vs 20.2%, P<0.0001) but no correlation was observed with either clinical or subclinical autoimmune disease. This large-scale study eliminates the possibility that CIpii increases the risk of autoimmune disease.

O50 L’utilisation prolongée de la mesure continue du glucose améliore l’équilibre glycémique chez des patients diabétiques de type 1 en traitement intensifié

Introduction La mesure continue du glucose (MCG) ameliore l’equilibre glycemique des patients diabetiques de type 1 (DT1) dans des etudes de 3 a 6 mois. L’objectif de cette etude est d’evaluer l’impact de deux modalites d’utilisation prolongee de la MCG sur l’equilibre glycemique. Patients et methodes Etude d’un an, multicentrique randomisee en ouvert et en 3 bras, chez 178 patients DT1 en traitement intensifie par injections multiples ou pompe et mal equilibres (HbA1c>8%). Deux modalites d’utilisation de la MCG (Freestyle Navigator, Abbott) (G1 : utilisation ad libitum, G2 : utilisation sur prescription graduee en fonction des resultats) sont comparees a l’utilisation de l’autosurveillance glycemique conventionnelle (G3 : controle). Le critere principal de jugement est la variation d’HbA1c entre le debut et la fin de l’etude. Resultats L’HbA1c s’ameliore de facon similaire dans les 2 groupes intervention, et de facon significative par rapport au groupe controle (G1 vs G3 : - 0,52%, p = 0,0006, G2 vs G3 : - 0,47%, p = 0,0008, G1+G2 vs G3 : - 0,50%, p Conclusion La MCG au long cours est associee a un meilleur controle glycemique chez les patients DT1 sous traitement intensifie. L’observance au port du capteur est determinante dans ce resultat. Travail realise avec le soutien de l’AFD (bourse de recherche) et d’Abbott (mise a disposition des capteurs).