Validation of a risk prediction model for early chronic kidney disease in patients with type 2 diabetes: Data from the German/Austrian Diabetes Prospective Follow-up registry.

AIM: To validate a recently proposed risk prediction model for chronic kidney disease (CKD) in type 2 diabetes (T2D). MATERIALS AND METHODS: Subjects from the German/Austrian Diabetes Prospective Follow-up (DPV) registry with T2D, normoalbuminuria, an estimated glomerular filtration rate of 60 ml/min/1.73m2 or higher and aged 39-75 years were included. Prognostic factors included age, body mass index (BMI), smoking status and HbA1c. Subjects were categorized into low, moderate, high and very high-risk groups. Outcome was CKD occurrence. RESULTS: Subjects (n = 10 922) had a mean age of 61 years, diabetes duration of 6 years, BMI of 31.7 kg/m2 , HbA1c of 6.9% (52 mmol/mol); 9.1% had diabetic retinopathy and 16.3% were smokers. After the follow-up (~59 months), 37.4% subjects developed CKD. The area under the curve (AUC; unadjusted base model) was 0.58 (95% CI 0.57-0.59). After adjustment for diabetes and follow-up duration, the AUC was 0.69 (95% CI 0.68-0.70), indicating improved discrimination. After follow-up, 15.0%, 20.1%, 27.7% and 40.2% patients in the low, moderate, high and very high-risk groups, respectively, had developed CKD. Increasing risk score correlated with increasing cumulative risk of incident CKD over a median of 4.5 years of follow-up (P < .0001). CONCLUSIONS: The predictive model achieved moderate discrimination but good calibration in a German/Austrian T2D population, suggesting that the model may be relevant for determining CKD risk.

[Use of artificial intelligence in screening for diabetic retinopathy at a tertiary diabetes center]. / Einsatz von künstlicher Intelligenz im Screening auf diabetische Retinopathie an einer diabetologischen Schwerpunktklinik.

BACKGROUND: In 2018, IDx-DR was approved as a method to determine the degree of diabetic retinopathy (DR) using artificial intelligence (AI) by the FDA. METHODS: We integrated IDx-DR into the consultation at a diabetology focus clinic and report the agreement between IDx-DR and fundoscopy as well as IDx-DR and ophthalmological image assessment and the influence of different camera systems. RESULTS: Adequate image quality in miosis was achieved more frequently with the Topcon camera (n = 456; NW400, Topcon Medical Systems, Oakland, NJ, USA) compared with the Zeiss camera (n = 47; Zeiss VISUCAM 500, Carl Zeiss Meditec AG, Jena, Germany). Overall, IDx-DR analysis in miosis was possible in approximately 60% of the patients. All patients in whom IDx-DR analysis in miosis was not possible could be assessed by fundoscopy with dilated pupils. Within the group of images that could be evaluated, there was agreement between IDx-DR and ophthalmic fundoscopy in approximately 55%, overestimation of severity by IDx-DR in approximately 40% and underestimation in approximately 4%. The sensitivity (specificity) for detecting severe retinopathy requiring treatment was 95.7% (89.1%) for cases with fundus images that could be evaluated and 65.2% (66.7%) when all cases were considered (including those without images in miosis which could be evaluated). The kappa coefficient of 0.334 (p < 0.001) shows sufficient agreement between IDx-DR and physician's image analysis based on the fundus photograph, considering all patients with IDx-DR analysis that could be evaluated. The comparison between IDx-DR and the physician's funduscopy under the same conditions shows a low agreement with a kappa value of 0.168 (p < 0.001). CONCLUSION: The present study shows the possibilities and limitations of AI-assisted DR screening. A major limitation is that sufficient images cannot be obtained in miosis in approximately 40% of patients. When sufficient images were available the IDx-DR and ophthalmological diagnosis matched in more than 50% of cases. Underestimation of severity by IDx-DR occurred only rarely. For integration into an ophthalmologist's practice, this system seems suitable. Without access to an ophthalmologist the high rate of insufficient images in miosis represents an important limitation.

Effect of Cold Atmospheric Plasma Therapy vs Standard Therapy Placebo on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial.

Importance: Diabetic foot ulcers are a common complication of diabetes and require specialized treatment. Cold atmospheric plasma (CAP) has been associated with benefits in wound infection and healing in previous smaller series of case reports. Yet the effect of CAP compared with standard care therapy in wound healing in diabetic foot ulcers remains to be studied. Objective: To determine whether the application of CAP accelerates wound healing in diabetic foot ulcers compared with standard care therapy. Design, Setting, and Participants: A prospective, randomized, placebo-controlled, patient-blinded clinical trial was conducted at 2 clinics with recruitment from August 17, 2016, to April 20, 2019. Patients were scheduled to remain in follow-up until April 30, 2024. Patients with diabetes and diabetic foot ulcers described using the combined Wagner-Armstrong classification of 1B or 2B (superficial or infected diabetic foot ulcers extending to tendon) were eligible. A patient could participate with 1 or more wounds in both groups in both intervention and control groups. Wounds were randomized separately, allowing a participant to be treated several times within the study following a 2 × 2 × 2 randomization strata considering sex, smoking status, and age (≤68 years and >68 years). Interventions: Standard care treatment with 8 applications of either CAP generated from argon gas in an atmospheric pressure plasma jet or 8 applications of placebo treatment in a patient-blinded manner. Main Outcomes and Measures: Primary end points were reduction in wound size, clinical infection, and microbial load compared with treatment start. Secondary end points were time to relevant wound reduction (>10%), reduction of infection, parameters of patient's well-being, and treatment-associated adverse events. Results: Of 65 diabetic foot ulcer wounds from 45 patients assessed for study, 33 wounds from 29 patients were randomized to CAP and 32 wounds from 28 to placebo, with 62 wounds from 43 patients (31 wounds per group) included for final evaluation (mean [SD] age, 68.5 [9.1] years for full sample). Four patients with 5 wounds of 31 (16.1%) wounds in the CAP group and 3 patients with 4 wounds of 31 (13%) wounds in the placebo group were active smokers. CAP therapy yielded a significant increase in wound healing, both in total mean (SD) area reduction (CAP vs placebo relative units, -26.31 [11.72]; P = .03) and mean (SD) time to relevant wound area reduction (CAP vs placebo relative units, 10% from baseline, 1.60 [0.58]; P = .009). Reduction of infection and microbial load was not significantly different between CAP and placebo. No therapy-related adverse events occurred during therapy; patient's perceptions during therapy were comparable. Conclusions and Relevance: In this randomized clinical trial, CAP therapy resulted in beneficial effects in chronic wound treatment in terms of wound surface reduction and time to wound closure independent from background infection. Trial Registration: ClinicalTrials.gov Identifier: NCT04205942.

[The metabolic syndrome in patients with type 1 diabetes mellitus. Associations with cardiovascular risk factors and cardiovascular morbidity]. / Metabolisches Syndrom bei Patienten mit Diabetes mellitus Typ 1. Auswirkungen auf das kardiovaskuläre Risikoprofil und die kardiovaskuläre Morbidität.

BACKGROUND AND PURPOSE: Type 1 diabetes is known to be associated with increased cardiovascular disease in the presence of nephropathy and hypertension. It was the aim of the present study to elucidate whether or not clinical findings of metabolic syndrome (MS) are further increasing cardiovascular morbidity among type 1 diabetics. METHODS: In the present cross-sectional study, 1,241 type 1 diabetics were included. These patients attended the Diabetes Clinic Karlsburg, Germany, from February 1, 2002 to December 31, 2003. The presence of the following findings was taken into consideration as clinical features of MS in type 1 diabetes: fasting triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), body mass index (BMI), daily insulin requirement/kg body weight (b.w.), increased blood pressure > 130/85 mmHg, including overt arterial hypertension. In each of the five categories the highest quintile in each sample was assessed: TG 2.9 +/- 3.6 mmol/l, HDL-C 1.48 +/- 0.46 mmol/l, BMI 29.1 +/- 4.98 kg/m(2) height, insulin requirement 0.71 +/- 0.23 IU/kg b.w., systolic blood pressure 130 +/- 12.3 mmHg. MS was defined as the presence of at least three categories. Among 1,241 type 1 diabetics (651 men, 590 women), 226 patients (129 men, 97 women) fulfilled the criteria of MS. The risk of MS was assessed by multiple regression analysis. Risk variables were: age, diabetes duration, sex, glycated hemoglobin (HbA(1c)), actual smoking, neuropathy, albumin excretion rate (AER), regular alcohol consumption, retinopathy, peripheral vascular disease (PVD), coronary heart disease (CHD), TGs, HDL-C, low-density lipoprotein cholesterol (LDL-C), cholesterol, blood pressure increase, BMI, increased insulin requirement, and foot syndrome. After adjusting for age, the variables were separately included into the mathematical model. The risk of MS was assessed after excluding the variables defining MS. RESULTS: Type 1 diabetics with MS were characterized by higher age (46 vs. 36 years; p < 0.01), and longer diabetes duration (19 vs. 16 years; p < 0.01). The risk of MS was independently associated (odds ratios) with higher age (40-59 years; 4.21; p < 0.01), increased HbA(1c) (1.41; p < 0.01), PVD (2.28; p < 0.01), CHD (2.19; p < 0.01), and the foot syndrome (4.17; p < 0.01). There were no significant associations of MS with type 2 diabetes heredity (first and second degree). CONCLUSION: Patients with type 1 diabetes and the presence of findings of MS are suffering from increased cardiovascular morbidity. The risk of MS increases with the age and HbA(1c). Life style factors such as weight gain and muscular inactivity seem to have an influence on the pathogenesis of MS in type 1 diabetes, thereby increasing cardiovascular morbidity.