Implantable insulin pumps: diagnosis and management of decreased flow rates using radionuclide investigation.

The aim of this study was to develop a diagnostic procedure for pumping unit malfunction by radionuclide imaging (RI) and to validate the method by comparing the results with those obtained using more conventional methods. Fifteen radionuclide investigations were performed in 11 patients with intraperitoneal implantable insulin pumps. One mCi of 99 mTc in 1 ml isotonic sodium chloride was injected into the reservoir. The results based on catheter visualization and peritoneal accumulation were compared blindly to the efficacy of alkaline rinses and laparoscopic findings. In all RI stoppage cases except one alkaline rinses failed to restore flow. Where laparoscopy was performed, comparisons were concordant i.e. no outflow from the tip of the catheter. The RI images obtained were reproduced in vitro using a pump under normal flow conditions and complete proximal and distal catheter obstruction. RI is a safe, quick non invasive method which allows the location of the site of pump/catheter malfunction within a one step procedure and the prediction of the efficacy of sodium hydroxide rinses.

Feasibility of intraperitoneal insulin therapy with programmable implantable pumps in IDDM. A multicenter study. The EVADIAC Study Group. Evaluation dans le Diabète du Traitement par Implants Actifs.

OBJECTIVE: To report the overall French experience, obtained through the collaboration of seven centers (EVADIAC [Evaluation dans le Diabète du Traitement par Implants Actifs] register), on the safety, feasibility, and efficacy of intraperitoneal insulin therapy by programmable implantable pumps, using three different devices. RESEARCH DESIGN AND METHODS: This is a multicenter prospective study involving 224 type I diabetic patients implanted with a programmable implantable pump (cumulative follow-up: 353 patient-years; mean duration: 1.5 +/- 0.9 years [mean +/- SD]. The Infusaid and the Promedos devices are equipped with a side port and refilled with U100 insulin (Hoechst 21 PH); the Minimed pump is not equipped with a side port and is refilled with U400 insulin (Hoechst 21 PH). Metabolic data and adverse events were recorded in a central register run by EVADIAC. RESULTS: A total of 29 local pump-pocket events (8/100 patient-years) and 9 pump failures (2.5/100 patient-years) occurred. The major technical problems were 1) pump flow rate reduction related to insulin aggregates, reversible after alkaline rinsing of the pump, and 2) 47 catheter obstructions requiring laparoscopic or conventional surgery. Pump therapy was abandoned in only 11 patients. HbA1c (7.4 +/- 1.8 vs. 6.8 +/- 1.0%, P < 0.001), mean glycemia (8.7 +/- 1.5 vs. 7.8 +/- 1.0 mmol/l, P < 0.001), and blood glucose SDs (3.8 +/- 0.8 vs. 3.3 +/- 0.8 mol/l, P < 0.001) decreased significantly after 6 months and remained lower than baseline thereafter. CONCLUSIONS: Intraperitoneal insulin infusion using an implantable programmable pump is a feasible and relatively safe technique that may improve metabolic control and glycemic stability. Long-term studies, however, are needed to demonstrate whether or not the improvement in glycemic control could be sustained for several years.

A cost-benefit comparison of intensive diabetes management with implantable pumps versus multiple subcutaneous injections in patients with type I diabetes.

OBJECTIVE: To investigate if intraperitoneal (IP) insulin infusion via programmable implantable pumps is a potential alternative to subcutaneous (SC) insulin via multiple injections. RESEARCH DESIGN AND METHODS: We compared the cost-benefits of the two methods using a randomized, prospective, 6-month, crossover design in 10 adult type I diabetic patients. RESULTS: When judged on the last month of IP versus SC periods in the nine patients who completed the study, metabolic data showed better glycemic control (HbA1c: 7.2 +/- 0.2 IP vs. 8.5 +/- 0.7% SC, mean +/- SE, P = 0.02), reduced glycemic fluctuations (SD of capillary glucose values: 3.4 +/- 0.2 IP vs. 4.6 +/- 0.2 mM SC, P < 0.01), and fewer mild hypoglycemic events (5.7 +/- 2.0 IP vs. 10.0 +/- 3.1 events/month SC, P = 0.02). Quality of life, judged by Diabetes Control and Complications Trial questionnaires, was unaffected by pump therapy. Direct costs, including pump acquisition, implantation, and follow-up, were 2.6-fold higher with IP than with SC delivery. CONCLUSIONS: The implantable pump is more effective in the short term, equally accepted, but more costly than multiple injections and should be limited to patients with unsatisfactory glycemic control despite intensive diabetes management with SC insulin. In addition, longer-term, larger-scale, and comparative evaluation is required.

[Cost benefits of intensive insulin therapy using injections, external pumps and implantable pumps]. / Coût-bénéfice de l'insulinothérapie intensive par injections, pompe externe et pompe implantable.

Since feasibility is now proven, cost-efficacy of external sub-cutaneous (EXT) and implantable programmable (IMP) insulin pumps needs to be compared to those of intensified conventional insulin therapy (CONV). Only metabolic efficacy and short-term direct costs are easily evaluable. We (WHO-CSII Study) and others have shown that glycemic control and severe hypoglycemia risk are slightly improved, while ketoacidosis risk and costs are aggravated with EXT vs CONV. We (CEDIT Study) and others have shown that glycemic control, mild and severe hypoglycemic risks are improved, with no increase in ketoacidosis rates although a doubling in costs with IMP vs CONV. Rigid interpretation of the above data would limit indications of insulin pumps to patients experiencing frequent hypoglycemias while on intensified conventional insulin therapy.

Insulinemic and glycemic indexes of six starch-rich foods taken alone and in a mixed meal by type 2 diabetics.

The glycemic index concept neglects the insulin secretion factor and has not been systematically studied during mixed meals. Six starch-rich foods were tested alone and in an isoglucido-lipido-protidic meal in 18 NIDDs and compared with a glucose challenge. These test meals were randomly assigned using a three factor experiment design. All three tests contained 50 g carbohydrate; mixed meals were adjusted to bring the same amount of fat (20 g), protein (24 g), water (300 mL), and calories (475 kcal) but not the same amount of fiber. Whatever the tested meals, foods elicited a growing glycemic index hierarchy from beans to lentils, rice, spaghetti, potato, and bread (mean range: 0.21 +/- 0.12-92 +/- 0.12, p less than 0.001). Mixing the meals significantly increased the insulinemic indexes (p less than 0.05) and introduced a positive correlation between glycemic and insulinemic indexes (n = 6, r = 0.903; p less than 0.05). The glycemic index concept remains discriminating, even in the context of an iso-glucido-lipido-protidic meal. Insulinemic indexes do not improve discrimination between foods taken alone in type 2 diabetics: they only discriminate between foods during mixed meals, similarly to glycemic indexes.

Lifestyle, metabolic control and social implications of pump therapy in 54 routine type I diabetic patients.

Our aims were to evaluate the clinical and social implications of continuous subcutaneous insulin infusion (CSII) in ordinary type 1 diabetics, followed on a routine basis using a simple (Mill Hill) or a more complex (Microject MC20, Ames) pump. Fifty four type 1 diabetics were studied during 2 randomized periods of 4 months, one of conventional treatment (CT) (2 to 3 injections/day, self blood glucose (BG) monitoring) and the other of CSII. Each period was preceded by a 5 day training course. We studied clinical parameters, metabolic control (daily values of BG strips, urine analysis, insulin reactions, HbA1c), and acceptability of the treatment to the patient and their relatives. We also recorded all their unexpected phone-calls, consultations and admission to hospital. Thirty-four patients the initial cohort, completed the study, 7 dropped-out, 9 interrupted CSII, mainly because of skin problems and 4 refused to revert back to CT. During CSII, patients noted slight disturbance of sleep (30%), sexual activity (68%), and the wearing of clothes (26%). The main concern was with moderate skin problems (71%) whereas the main advantages were dietary liberalization, reduced numbers of insulin reactions and an improved feeling of well being. The type of pump used did not affect the results. Though acceptability was good in every patient trying the pump, it was better in those who asked to keep the pump after the trial (p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Sucrose or honey at breakfast have no additional acute hyperglycaemic effect over an isoglucidic amount of bread in type 2 diabetic patients.

Exclusion of simple sugars from the diabetic diet is not always followed by patients and may not even be as crucial as was hitherto thought. We tested three types of mixed breakfasts (400 kcal, 50 g HCO) including an isoglucidic amount either of white bread (30 g), honey (20 g) or sucrose (15 g), at the critical morning period i.e. for breakfast, in a group of 21 Type 2 (non-insulin-dependent) diabetic patients (6 well- and 15 badly controlled). Mean plasma glucose and insulin levels were comparable on the three occasions: respectively with bread, sucrose and honey, peak glucose values were 18 mmol/l, 17.7 mmol/l and 17.5 mmol/l in the uncontrolled group versus 13.9 mmol/l, 12.8 mmol/l and 12.7 mmol/l in the well-controlled group. Peak insulin values were 33.6 mU/1,34.0 mU/l and 36.3 mU/l (p greater than 0.05) in uncontrolled patients against 57.5 mU/l, 54.8 mU/l and 52.5 mU/l in well-controlled subjects (p greater than 0.05). The mean increment in peak plasma glucose values for the three breakfasts was as follows: 6.9 mmol/l, 6.3 mmol/l and 6.2 mmol/l for the uncontrolled group against 7.2 mmol/l, 5.9 mmol/l and 6.2 mmol/l in well-controlled subjects; the mean increment in peak plasma insulin levels was 21.8 mU/l,22.0 mU/l and 24.2 mU/l in the controlled group versus 38.2 mU/l, 32.0 mU/l and 34.7 mU/l in the well-controlled subjects, all values being non-significantly different (p greater than 0.05). We conclude that, in acute conditions, simple sugars have no additional hyperglycaemic effect over an isoglucidic amount of bread in well-and in badly controlled Type 2 diabetic patients, even at breakfast.

Sucrose taken during mixed meal has no additional hyperglycaemic action over isocaloric amounts of starch in well-controlled diabetics.

The hyperglycaemic effect of 20 g sucrose taken at the end of a regular mixed meal by diabetic patients was measured in six adult type 1 diabetics, C-peptide negative, controlled by the artificial pancreas, and twelve adult type 2 diabetics, with fasting plasma glucose levels below 7.2 mmol/l (130 mg/100 ml) and post-prandial plasma glucose levels below 10.0 mmol/l (180 mg/100 ml), treated by diet alone or with glibenclamide and/or metformin. All the patients were given on consecutive days, in random order, two mixed meals of grilled meat, green beans, and cheese, as well as a cake made either of rice, skimmed milk, and saccharine (meal A) or rice, skimmed milk, and 20 g sucrose (meal B). The meals contained equal amounts of calories and of carbohydrate. There was no difference between the meals in plasma glucose curves and plasma insulin or insulin infusion rate variations whether in peak values, peaking times, or areas under the curves, in either group of patients. Sparing use of sucrose taken during mixed meals might help well-controlled diabetic patients to comply with their daily dietary prescription while maintaining good blood glucose control.