Multicentre, randomised, controlled study of the impact of continuous sub-cutaneous glucose monitoring (GlucoDay) on glycaemic control in type 1 and type 2 diabetes patients.

AIM: This randomised study was designed to investigate the impact of continuous glucose monitoring (CGM) for 48h on glycaemic control with a 3-month follow-up in patients with type 1 (T1D) or type 2 (T2D) diabetes. METHODS: A total of 48 patients with poor glycaemic control (HbA(1c): 8-10.5%) underwent CGM for 48h using the GlucoDay((R)) system (A. Menarini Diagnostics), after which they were randomly assigned to treatment adjustments based on either their CGM profile (CGM group) or their usual self-monitoring of blood glucose (SMBG group). HbA(1c) measurement and 48-h CGM were repeated 3 months later. RESULTS: Altogether, 34 patients with either T1D (n=9) or T2D (n=25) completed the study; seven patients chose to leave the study, and seven patients in the CGM group were excluded because their baseline CGM graphs were not interpretable. HbA(1c) levels decreased significantly in the CGM group (n=14, -0.63+/-0.27%; P=0.023), but not in the controls (n=20, -0.28+/-0.21%; P=0.30). In T2D patients, the improvement associated with CGM vs SMBG was due to HbA(1c) decreases (mean: -0.63+/-0.34%; P=0.05 vs -0.31+/-0.29%; P=0.18, respectively). However, HbA(1c) did not change significantly with CGM in T1D patients. Comparisons of CGM data at baseline and after 3 months showed no significant changes in glucose control, glucose variability or hypoglycaemia. No major adverse events related to the GlucoDay system were reported. CONCLUSION: This is the first randomised study showing that CGM improves glycaemic control in patients with T2D.

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 (Hashimoto's 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.

What could be the reasons for giving up the implanted pump treatment?

The development of implanted insulin pump treatment has been particularly intense in France and French implanting centers joined to form an association called EVADIAC. The data collected by EVADIAC have clearly documented benefits as well possible problems with this treatment mode. In comparison with SC administration, intraperitoneal (IP) insulin infusion via an implanted pump achieves good metabolic control, improves long-term stability of diabetes and significantly reduces the risk of severe hypoglycemia. Problems can involve pump slowdown, catheter obstruction or local complication at the implantation site. With respect to the benefits, the rate of complications is highly acceptable. However, amongst the implanted diabetic patients, some elect to give up such a treatment mode. In a retrospective study we intended to examine their reasons for giving up this treatment. In our center, the patients who elected by themselves to give up the implanted pump account for 16% of all treated patients. This group of patients did not have, as compared to other implanted patients, less benefits nor more restrictions or incidents that could have impaired their well being. The reasons for giving up the implanted pump seem more often to be related to the refusal of a strict and institutional management linked to this treatment.

How and when to use an alternative site in self-monitoring of blood glucose.

Taking care of diabetic patients has considerably been improved for approximately fifty years both in the therapeutic field and in the glycaemia monitoring field. Prospective studies conducted on large cohorts have clearly shown the importance of taking optimal care of such patients in order to prevent the occurrence or aggravation of chronic diabetes-associated complications. However, despite the simplification of self-monitoring of blood glucose through technological developments, drawbacks, some of which are linked to the sampling site, the fingertip, still slow down the patients' compliance. The use of an alternative site seems to be one of the solutions to offer in order to improve their monitoring and hence, their metabolic control. The development of such a monitoring mode has been slowed down after revealing, in some studies, a probably physiological delay in the detection of glycaemia variations, at the level of the alternative sites. Despite such conflicting observations, interest of using such alternative sites is to be defined in self-monitoring. Beside fast glycaemia variations, it proved to be reliable.

[History, accuracy and precision of SMBG devices]. / Technologie et fiabilité de l'autosurveillance glycémique: historique et état actuel.

Self-monitoring of blood glucose started only fifty years ago. Until then metabolic control was evaluated by means of qualitative urinary blood measure often of poor reliability. Reagent strips were the first semi quantitative tests to monitor blood glucose, and in the late seventies meters were launched on the market. Initially the use of such devices was intended for medical staff, but thanks to handiness improvement they became more and more adequate to patients and are now a necessary tool for self-blood glucose monitoring. The advanced technologies allow to develop photometric measurements but also more recently electrochemical one. In the nineties, improvements were made mainly in meters' miniaturisation, reduction of reaction time and reading, simplification of blood sampling and capillary blood laying. Although accuracy and precision concern was in the heart of considerations at the beginning of self-blood glucose monitoring, the recommendations of societies of diabetology came up in the late eighties. Now, the French drug agency: AFSSAPS asks for a control of meter before any launching on the market. According to recent publications very few meters meet reliability criteria set up by societies of diabetology in the late nineties. Finally because devices may be handled by numerous persons in hospitals, meters use as possible source of nosocomial infections have been recently questioned and is subject to very strict guidelines published by AFSSAPS.