One-year real-world performance of the DBLG1 closed-loop system: Data from 3706 adult users with type 1 diabetes in Germany.

AIM: The Diabeloop Generation 1 (DBLG1) system is an interoperable hybrid closed-loop solution that was commercialized in Germany in March 2021. We report the longitudinal glycaemic outcomes among the first 3706 users in a real-world setting. METHODS: We performed a retrospective data collection of all consenting adult patients with type 1 diabetes who were equipped in Germany with the DBLG1 system before 30 April 2022, and with a minimum 14 days of closed-loop usage. RESULTS: In total, 3706 users (41% women, age 45.1 ± 14.5 years) met the inclusion criteria, reaching a mean follow-up of 131.0 ± 85.1 days, an overall 485 600 days of continuous glucose monitoring data, and a median time spent in closed-loop of 95.0% (IQR 89.1-97.4). The median percentage time in range (70-180 mg/dl) was 72.1% (IQR 65.0-78.9); the time below 70 mg/dl was 0.9% (0.5-1.7), the time below 54 mg/dl was 0.1% (0.1-0.3), and the median Glucose Management Index was 7.0% (6.8-7.3). Exploratory analysis of a subset of 2460 patients in whom baseline glycated haemoglobin (HbA1c) was available [7.4% (IQR 6.9-8.0)] showed that the achieved mean time in range was influenced by baseline HbA1c, ranging from 65.8 ± 9.9% (A1c ≥8.5%) to 81.3 ± 6.8% (A1c <6.5%). CONCLUSION: This large real-world analysis confirms the relevance of the DBLG1 automated insulin delivery solution for the achievement of standards of care in adult patients with type 1 diabetes.

Digital Diabetes Management: A Literature Review of Smart Insulin Pens.

Digital health management is increasingly pivotal in the care of patients with diabetes. The aim of this review was to evaluate the clinical benefits of using smart insulin pens with connectivity for diabetes management. The search was performed using PubMed and PubMed Central on May 15, 2019, to identify publications investigating the use of insulin pens. Studies evaluating insulin pens with connectivity via Bluetooth/Near Field Communication, with an associated electronic device enabling connectivity, or with a memory function were included in the review. Nine studies were identified in the search. Overall, these studies lacked data on smart insulin pens with a connectivity function, with eight of the available studies investigating only pens with a memory function. The studies focused primarily on assessing patient preference, usability, and technical accuracy. The number of studies assessing clinical outcomes was small (n = 3). However, the majority of studies (n = 8) reported that patients preferred smart insulin pens because they increased confidence with regard to diabetes self-management. These results suggest a lack of published data regarding smart insulin pens with connectivity for the management of diabetes. However, the available published data on usability and patient preference suggest that the use of smart insulin pens holds promise for improving and simplifying diabetes self-management.

Safety and glycemic outcomes of do-it-yourself AndroidAPS hybrid closed-loop system in adults with type 1 diabetes.

BACKGROUND: The aim of the study was to assess the safety and glycemic outcomes with the use of a Do-It-Yourself (DIY) Hybrid Closed-Loop (HCL) system based on the AndroidAPS application in type 1 diabetes (T1D). METHODS: Single-center clinical trial, with 3-week run-in and 12-week study period. DIY HCL system consisted of the Dana Diabecare RS insulin pump, Dexcom G5 continuous glucose monitoring system and AndroidAPS application. Primary outcome was safety: incidences of severe hypoglycemia, diabetic ketoacidosis, time spent in glycemia <54 mg/dl. Secondary endpoints included percentage of time in range (TIR) 70-180 mg/dl, time below 70 mg/dl, HbA1c, insulin requirements, and body weight. RESULTS: In total 12 subjects (5 men, 7 women) were enrolled, mean age 31.3±6.7, 95%CI(27.7-34.9) years, mean diabetes duration 16.1±5.7, 95%CI(13.0-19.2) years. No episodes of severe hypoglycemia or ketoacidosis were observed. Percentage of time spent in glycemia below 54mg/dl was not increased. Average sensor glycemia was lower in the study period than baseline (141.1 ± 8.4, 95%CI(136.3-145.9) vs. 153.3 ± 17.9, 95%CI(143.2-163.4), mg/dl p<0.001). TIR 70-180 mg/dl was improved by 11.3%, 95%CI(2.8%-19.8%) (from 68.0 ± 12.7 to 79.3 ± 6.4%, p<0.001), without increasing hypoglycemia time. The HbA1c level decreased by -0.5%, 95%CI(-0.9%--0.1%) (from 6.8 ± 0.5 to 6.3 ± 0.4%, p<0.001). Additionally, in the last 4 weeks of the study period participants significantly improved and showed TIR 70-180 mg/dl 82.1 ± 5.6%, 95%CI(78.9-85.3), time <54 mg/dl 0.30 (0.20-0.55)%, median 95%CI(0.1-0.7) and <70 mg/dl 1.90 (1.10-3.05)%, median 95%CI(0.7-3.2). The insulin requirement and body weight did not change in the study. CONCLUSIONS: The study revealed safety of the Do-It-Yourself HCL system AndroidAPS in adults with T1D, limited to well-controlled, highly selected and closely monitored patients. The use of AndroidAPS significantly improved HbA1c, time in range and average sensor glycemia without increasing hypoglycemia. As both patients and their medical team are gaining experience using the system over time, they improve glycemic control. TRIAL REGISTRATION: German Clinical Trials Register: no. DRKS00015439; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015439.

New Design of a Percutaneous Port System for Continuous Intraperitoneal Insulin Infusion.

Insulin-dependent diabetes mellitus is treated with intensive insulin therapy using multiple daily injections or continuous subcutaneous insulin infusion with insulin pumps. For people with diabetes who cannot achieve acceptable glycemic control despite the use of intensive insulin therapy and continuous glucose measurement, there exists the possibility of continuous intraperitoneal insulin delivery via an implantable pump or a percutaneous port system that is connected to an external insulin pump. In this article, the current second generation of the Accu-Chek® DiaPort system for continuous intraperitoneal insulin delivery with its improvements over the former generation is presented and discussed.

SPECTRUM.

BACKGROUND: Optimal usage of continuous glucose monitoring (CGM) requires adequate training of the users. Providing patients with a CGM system without such a training usually doesn't lead to the intended improvement in metabolic control. METHODS: In Germany we developed a structured training program ("SPECTRUM") to ensure a high quality standard for the use of CGM systems. RESULTS: This program is suitably for patients of all age groups and is applicable to all CGM systems and all forms of insulin therapy. A curriculum was also developed so that training centers with less experience with CGM could become capable of offering comprehensive CGM training. CONCLUSIONS: We believe that usage of such a program can be an important step forward in achieving more widespread acceptance and use of CGM systems. Translations in other languages and evaluation with a controlled clinical trial are planned.

The fading of reported effectiveness. A meta-analysis of randomised controlled trials.

BACKGROUND: The "real" effect size of a medical therapy is constant over time. In contrast, the effect size reported in randomised controlled trials (RCTs) may change over time because the sum of all kinds of bias influencing the reported effectiveness is not necessarily constant. As this would affect the validity of meta-analyses, we tested the hypothesis that the reported effect size decreases over time. Furthermore, we tested three hypotheses that would explain a possible change. METHODS: Because of well established outcome measures, the lipid-lowering drugs Pravastatin and Atorvastatin (serum low-density lipoprotein cholesterol, LDL-C) and the anti-glaucoma drugs Timolol and Latanoprost (intraocular pressure, IOP) were chosen for this investigation. Studies were identified by a standardized MEDLINE search. RCTs investigating the above identified medications administered as monotherapy, and in defined dosages, were included. Publication year, baseline (= pre-treatment value in the treatment group of interest) and post intervention means, number of patients and the assignment to experimental or control group were extracted for each study. RESULTS: A total of 625 citations were screened; 206 met the inclusion criteria. The reported effect size of Pravastatin (change of reported effect size in five years: -3.22% LDL-C, P < .0001), Timolol (-0.56 mmHg, P < .0001) and Latanoprost (-1.78 mmHg, P = .0074) decreased over time, while there was no significant change for Atorvastatin (+0.31% LDL-C, P = .8618). Multiple regression analysis showed that baseline values were the most important influencing factor; study size or treatment group did not play a significant role. CONCLUSION: The effectiveness of medical therapies reported in RCTs decreases over time in three of the four investigated pharmaceuticals, caused mainly by baseline differences. We call this phenomenon "fading of reported effectiveness". Under this condition the validity of a meta-analysis may be impaired. Therefore we propose to observe this phenomenon in future meta-analyses in order to guarantee a maximum of transparency.