Effect of sensor-augmented pump treatment vs. multiple daily injections on albuminuria: a 1 year randomized study

CONTEXT: The effect of glycaemic control on persisting albuminuria remains unclear. Insulin delivery and glucose variability may be important Objective: To investigate the effect of 1 year treatment with sensor-augmented insulin pump (SAP) or multiple daily injections (MDI) on albuminuria.

DESIGN: Randomized controlled open-label parallel trial.

PATIENTS AND METHODS: 60 type 1 diabetes patients, with a history of albuminuria and on stable RAS-inhibition, were randomized to SAP or MDI. Urine albumin creatinine ratio (UACR) was measured in 3 urine samples at all visits. Glucose variability and glomerular filtration rate ((51)Cr-EDTA-GFR) were measured at beginning and study end. Using linear mixed model, change in UACR between groups was analysed as intention-to-treat.

MAIN OUTCOME MEASURE: Change in UACR.

RESULTS: 55 patients (SAP:n=26; MDI:n=29) completed. Diabetes duration (mean±SD): 33±12 years, UACR (geometric mean,IQR): 99(37-233) mg/g, (51)Cr-EDTA-GFR: 94±22 ml/min/1.73m(2), HbA1c: 9.0±1.1%, glucose variability (calculated as SD): 4.0±1.0 mmol/l; no groups differences (P≥0.06 for all). After 1 year, change in UACR was (mean(95%CI)) -13(-39-22) with SAP vs. 30(-12-92)% on MDI treatment (unadjusted: P=0.051; adjusted for HbA1c, P=0.04). HbA1c decreased 1.3±1.0 vs. 0.6±1.0% (P=0.013), glucose variability decreased 0.9±1.1 vs. 0.3±1.0 mmol/l (P=0.04), and (51)Cr-EDTA-GFR declined 5.6±9.6 vs. 3.4±13 ml/min/1.73m(2) (P=0.50) with SAP vs. MDI treatment. No changes in blood pressure (P≥0.27).

CONCLUSION: SAP treatment reduced UACR in a randomized controlled trial in type 1 diabetes patients with a history of albuminuria on stable RAS-inhibition. Significance was reached after adjustment. SAP treatment reduced HbA1c and glucose variability (calculated as SD).