Search

Type 2 diabetes is a chronic progressive disease with increasing drug demands. It is comprised of a hereditary ß-cell dysfunction, (ßCD), insulin resistance (IR), and chronic systemic inflammation (CSI), which can be present with different degrees of severity. We have tested an alternative approach to the common drug escalation programs. DET (De-Escalation Treatment), temporary, multi-drug intervention targets to improve ß-Cell function and reverse disease progression. A personalized drug combination for a three-month treatment is determined based on a biomarker panel consisting of classic and new biomarkers. 22 patients (8 women, 14 men, age: 62±8 yrs., disease duration: 12±7 yrs., HbA1c: 7.8 %, BMI: 33.2±2.4 kg/m², treatment with 1 or 2 oral drugs) were treated with follow-up periods of up to 12 years. DET consisted of low doses each of basal insulin to address ßCD, treatment of IR (exercise and/or pioglitazone), a drug to reduce CSI (diet, GLP-1, or SGLTII) and a hypoglycemic intervention (metformin, or DPP-IV). The DET approach was well tolerated (nausea: 4 cases, edema: 1 case). All patients experienced a normalization or pronounced improvement of glycemic control without report of hypoglycemia. Mean HbA1c after 3 months was 5.9±0.4 %. Intact proinsulin decreased from 9.3±2.1 pmol/L to 2.3±0.6 pmol/L, adiponectin improved from 3.4±1.2 to 8.6±2.4 mg/dL, and mean body weight decreased by 2.4±1.1 kg (all: p11 years). Regeneration of ß-cell function by means of DET resulted in a temporary stop of chronic disease progression. A formal prospective clinical study to investigate the practicability of this approach in routine clinical practice is currently ongoing. Disclosure A. Pfützner: Consultant; Self; LifeCare, Inc., Novo Nordisk A/S. Research Support; Self; CNOGA Medical, Esperion Therapeutics, Inc. Speaker’s Bureau; Self; Sanofi-Aventis. A. Manessis: Research Support; Self; Novo Nordisk Inc., Sciema GmbH. L. Do: Research Support; Self; Sciema GmbH. M. Hanna: None. Funding Diabetes Treatment Centers International

Regular blood glucose self-testing is considered to be the most painful procedure during daily treatment routine for patients with diabetes mellitus. This pilot study was undertaken to evaluate the performance of TensorTip CoG, a non-invasive glucose monitoring device (NI-CoG, CNOGA Medical, Israel) on glycemic control and daily measurement aspects in patients with type 1 and type 2 diabetes. The study was performed with 6 type 1 patients (T1D: 3 male/3 female, age: 43±16 years, HbA1c: 8.0±0.5%), and 15 type 2 patients (T2D: 8 male/7 female, 62±6 years, 7.2±1.3%). The participants used the NI-CoG device at home after an initial standardized meal experiment to evaluate device performance in comparison to a standard reference method (YSI Stat2300 plus). In addition, HbA1c was assessed and a treatment satisfaction questionnaire was completed after a period of three months of home use. During the meal experiment, NI-CoG showed good accuracy (mean bias: 15.3%; consensus error grid: 100% in zones A and B). A trend for HbA1c improvement was seen in both groups over 3 months (T1D: -0.22%, T2D: -0.1%, n.s.). Patients reported to measure more frequently, and to feel more comfortable with the non-invasive measurement procedure. Use of the device in the study initiated the general desire to switch to the new device also for daily routine use. The non-invasive TensorTip device was shown to increase the frequency of glucose testing and to have a positive impact on patients' perception of the measurement procedure. There was also an initial trend for improvements of glycemic control within the first three months of use in this pilot study. Disclosure A. Pfützner: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Consultant; Self; Lifecare. Speaker's Bureau; Self; Berlin-Chemie AG. Research Support; Self; Boehringer Ingelheim GmbH. A. Lier: None. S. Ramljak: None. F. Demircik: None.

Background: Pain-free assessment of the glucose information required for treatment monitoring is one of the most desired unmet medical needs in insulin treated patients with type 1 diabetes. TensorTip CoG, is a non-invasive tissue glucose monitoring device (NI-CoG) with an additional built-in invasive glucose meter (Inv-CoG), which operates based on optical methods in the near-infrared and visible wavelength range. Here we report about the results obtained from type 1 patients in the course of two clinical studies. Methods: The data from 6 patients with type 1 diabetes (3 male/3 female, age: 43±16 years, HbA1c: 8.0±0.5%), who had participated in a standard meal study experiment, and the results from 29 type 1 patients, who had participated in a system accuracy evaluation in accordance with ISO15197:2015 (13 male/16 female, age: 42±14 years, HbA1c: 7.5±0.5%) were combined for this analysis. Results: The meal study patients (n = 66 data points) and the ISO study patients (n = 29) showed good agreement of the NI-CoG predicted tissue glucose with the capillary reference method (YSI Stat2300 plus). Mean absolute relative difference (values >100 mg/dL) was calculated to be 13.3% (mean absolute difference for values Conclusions: The results of this new non-invasive glucose prediction device are encouraging for routine use in patients with type type 1 diabetes. This non-invasive technology has reached an accuracy level for glucose prediction that is comparable to the results published for needle sensors working for flash or continuous glucose monitoring. Disclosure A. Pfützner: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Consultant; Self; Lifecare. Speaker's Bureau; Self; Berlin-Chemie AG. Research Support; Self; Boehringer Ingelheim GmbH. F. Demircik: None. A. Lier: None. S. Ramljak: None.

Insulin has to be kept at 4-8° C (∼ 39°F to 47°F) until use and once opened, is supposed to be stable for 28 to 30 days at room temperature. Exposure to extreme cold or heat leads to insulin degradation in a very short time with loss of glucose-lowering efficacy. ViVi-Cap (TempraMed Inc.) is a reusable storage device, which is available for all existing disposable pen devices in the U.S. and EU. It works without external power supply requirements based on an ultra-high vacuum insulation and an additional heat consumption by a calorimetry-based phase-change technology. Five disposable insulin pens (FlexPen, Insulin aspart) were kept for one week under extreme temperature conditions for 5 days (each day: 8 h at 50 °C and 16 h at 22 °C) either without protection, in a frio device (freshly prepared each day) and in the ViViCap. Samples were taken every day and insulin degradation was determined in accordance with U.S. pharmacopoia by appropriate HPLC methods for insulin aspart, and high and low molecular weight degradation molecules. Each experiment was performed in triplicate. Insulin aspart without protection was shown to have more than 2% impurities already after one day (Frio: 2 days, ViViCap: >5 days). High molecular weight products appeared in measurable quantities after two days without protection (Frio: 3 days, ViViCap > 5 days, p ViVi-Cap was superior to the other tested conditions with respect to stabilizing insulin aspart during storage under extreme temperature conditions. The device provides an easy to use solution for maintaining insulin efficacy under daily life conditions. Disclosure A. Pfützner: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Consultant; Self; Lifecare. Speaker's Bureau; Self; Berlin-Chemie AG. Research Support; Self; Boehringer Ingelheim GmbH. R. Nagar: Stock/Shareholder; Self; TempraMed Ltd.. W. Reeh: None.

Insulin lispro, an insulin analog recently developed particularly for mealtime therapy, has a fast absorption rate and a short duration of action. We compared insulin lispro and regular human insulin in the mealtime treatment of 1,008 patients with IDDM. The study was a 6-month randomized multinational (17 countries) and multicenter (102 investigators) clinical trial performed with an open-label crossover design. Insulin lispro was injected immediately before the meal, and regular human insulin was injected 30–45 min before the meal. Throughout the study, the postprandial rise in serum glucose was significantly lower during insulin lispro therapy. At the endpoint, the postprandial rise in serum glucose was reduced at 1 h by 1.3 mmol/l and at 2 h by 2.0 mmol/l in patients treated with insulin lispro (P < 0.001). The rate of hypoglycemia was 12% less with insulin lispro (6.4 ± 0.2 vs. 7.2 ± 0.3 episodes/30 days, P < 0.001), independent of basal insulin regimen or HbA1c level. The reduction was observed equally in episodes with and without symptoms. When the total number of episodes for each patient was analyzed according to the time of occurrence, the number of hypoglycemic episodes was less with insulin lispro than with regular human insulin therapy during three of four quarters of the day (P < 0.001). The largest relative improvement was observed at night. In conclusion, insulin lispro improves postprandial control, reduces hypoglycemic episodes, and improves patient convenience, compared with regular human insulin, in IDDM patients.