Performance of Dexcom G5 and FreeStyle Libre sensors tested simultaneously in people with type 1 or 2 diabetes and advanced chronic kidney disease.

BACKGROUND: Advanced chronic kidney disease (CKD) is a common complication for people with type 1 and 2 diabetes and can often lead to glucose instability. Continuous glucose monitoring (CGM) helps users monitor and stabilize their glucose levels. To date, CGM and intermittent scanning CGM are only approved for people with diabetes but not for those with advanced CKD. AIM: To compare the performance of Dexcom G5 and FreeStyle Libre sensors in adults with type 1 or 2 diabetes and advanced CKD. METHODS: This was a non-randomized clinical trial that took place in two outpatient clinics in western Sweden. All patients with type 1 or 2 diabetes and an estimated glomerular filtration rate (eGFR) of < 30 mL/min per 1.73 m2 were invited to participate. Forty patients (full analysis set = 33) carried the Dexcom G5 sensor for 7 d and FreeStyle Libre sensor for 14 d simultaneously. For referencing capillary blood glucose (SMBG) was measured with a high accuracy glucose meter (HemoCue®) during the study period. At the end of the study, all patients were asked to answer a questionnaire on their experience using the sensors. RESULTS: The mean age was 64.1 (range 41-77) years, hemoglobin A1c was 7.0% [standard deviation (SD) 3.2], and diabetes duration was 28.5 (SD 14.7) years. A total of 27.5% of the study population was on hemodialysis and 22.5% on peritoneal dialysis. The mean absolute relative difference for Dexcom G5 vs SMBG was significantly lower than that for FreeStyle Libre vs SMBG [15.2% (SD 12.2) vs 20.9% (SD 8.6)], with a mean difference of 5.72 [95% confidence interval (CI): 2.11-9.32; P = 0.0036]. The mean absolute difference was also significantly lower for Dexcom G5 than for FreeStyle Libre, 1.21 mmol/L (SD 0.78) and 1.76 mmol/L (SD 0.78), with a mean diffrenec of 0.55 (95%CI: 0.27-0.83; P = 0.0004).The mean difference (MD) was -0.107 mmol/L and -1.10 mmol/L (P = 0.0002), respectively. In all, 66% of FreeStyle Libre values were in the no risk zone on the surveillance error grid compared to 82% of Dexcom G5 values. CONCLUSION: Dexcom G5 produces more accurate sensor values than FreeStyle Libre in people with diabetes and advanced CKD and is likely safe to be used by those with advanced CKD.

Excess risk of lower extremity amputations in people with type 1 diabetes compared with the general population: amputations and type 1 diabetes.

Objective: This study investigates how the excess risk of lower extremity amputations (amputations) in people with type 1 diabetes mellitus (DM) differs from the general population by diabetes duration, glycemic control, and renal complications. Research design and methods: We analyzed data from people with type 1 DM from the Swedish National Diabetes Register without prior amputation from January 1998 to December 2013. Each person (n=36 872) was randomly matched with five controls by sex, age, and county (n=184 360) from the population without diabetes. All were followed until first amputation, death or end of follow-up. Results: The overall adjusted HR for all amputation was 40.1 (95% CI 32.8 to 49.1) for type 1 DM versus controls. HR increased with longer diabetes duration. The incidence of amputation/1000 patient-years was 3.18 (95% CI 2.99 to 3.38) for type 1 DM and 0.07 (95% CI 0.05 to 0.08) for controls. The incidence decreased from 1998-2001 (3.09, 95% CI 2.56 to 3.62) to 2011-2013 (2.64, 95% CI 2.31 to 2.98). The HR for major amputations was lower than for minor amputations and decreased over the time period (p=0.0045). Worsening in glycemic control among patients with diabetes led to increased risk for amputation with an HR of 1.80 (95% CI 1.72 to 1.88) per 10 mmol/mol (1%) increase in hemoglobin A1c. Conclusions: Although the absolute risk of amputation is relatively low, the overall excess risk was 40 times that of controls. Excess risk was substantially lower for those with good glycemic control and without renal complications, but excess risk still existed and is greatest for minor amputations.

Investigation of early signs of systolic and diastolic dysfunction among persons with type 1 diabetes.

Background: Persons with type 1 diabetes have a higher risk to develop heart failure than the general population, and the mechanism behind the increased risk is unclear. In epidemiological studies with hospitalisation for heart failure as endpoint HbA1c, body mass index and decreased kidney function are significant risk factors, but it is unclear how these risk factors influence the development of heart failure. Methods: In this study, we investigated early signs of systolic and diastolic dysfunction with transthoracic echocardiography. Statistical analysis on correlation of risk factors and early signs of diastolic and systolic dysfunction was made. Results: In this study population of 287 persons with type 1 diabetes, 160 were men and 127 were women with a mean age of 53.8 (SD 11.6) years and a mean diabetes duration of 36.2 (SD 13.5) years. There were 23 (8.2%) persons who fulfilled the definition of systolic dysfunction (ejection fraction <50% or regional wall motion abnormalities) and 24 persons (9%) the definition for diastolic dysfunction. When comparing the groups with either systolic or diastolic dysfunction to the rest of the population, the only significant risk factor was age in both groups and previous myocardial infarction in the systolic group. Conclusion: In our study population with type 1 diabetes, we found signs of diastolic dysfunction in 9% and systolic dysfunction in 8.2%. Compared with published data from the general population, this rate is somewhat higher in a younger population. Only age was a significant risk factor in the study.

Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial.

Importance: The majority of individuals with type 1 diabetes do not meet recommended glycemic targets. Objective: To evaluate the effects of continuous glucose monitoring in adults with type 1 diabetes treated with multiple daily insulin injections. Design, Setting, and Participants: Open-label crossover randomized clinical trial conducted in 15 diabetes outpatient clinics in Sweden between February 24, 2014, and June 1, 2016 that included 161 individuals with type 1 diabetes and hemoglobin A1c (HbA1c) of at least 7.5% (58 mmol/mol) treated with multiple daily insulin injections. Interventions: Participants were randomized to receive treatment using a continuous glucose monitoring system or conventional treatment for 26 weeks, separated by a washout period of 17 weeks. Main Outcomes and Measures: Difference in HbA1c between weeks 26 and 69 for the 2 treatments. Adverse events including severe hypoglycemia were also studied. Results: Among 161 randomized participants, mean age was 43.7 years, 45.3% were women, and mean HbA1c was 8.6% (70 mmol/mol). A total of 142 participants had follow-up data in both treatment periods. Mean HbA1c was 7.92% (63 mmol/mol) during continuous glucose monitoring use and 8.35% (68 mmol/mol) during conventional treatment (mean difference, -0.43% [95% CI, -0.57% to -0.29%] or -4.7 [-6.3 to -3.1 mmol/mol]; P < .001). Of 19 secondary end points comprising psychosocial and various glycemic measures, 6 met the hierarchical testing criteria of statistical significance, favoring continuous glucose monitoring compared with conventional treatment. Five patients in the conventional treatment group and 1 patient in the continuous glucose monitoring group had severe hypoglycemia. During washout when patients used conventional therapy, 7 patients had severe hypoglycemia. Conclusions and Relevance: Among patients with inadequately controlled type 1 diabetes treated with multiple daily insulin injections, the use of continuous glucose monitoring compared with conventional treatment for 26 weeks resulted in lower HbA1c. Further research is needed to assess clinical outcomes and longer-term adverse effects. Trial Registration: clinicaltrials.gov Identifier: NCT02092051.