This is a multi-center, retrospective, longitudinal study, involving 31 patients with type 1 diabetes mellitus and overt diabetic nephropathy. All patients were on intensive (four daily shots) insulin therapy and weekly APS. All patients were on ACE therapy and aggressive antihypertensive regimens. All patients were followed with creatinine clearance measurements.

Patients were followed for an average of 37 months. Creatinine clearance remained essentially unchanged during this period. These observations suggested that APS could successfully stabilize renal function in patients with diabetic nephropathy.

Effects of pulsatile intravenous insulin therapy (APS) on the progression of diabetic nephropathy: Dailey, et al. Metabolism (2000) 49: 1491-1495.

The Dailey study is a multi-institutional prospective, randomized, controlled study evaluating the effect of APS in patients with diabetic nephropathy. This study included diabetic centers at Mayo Clinic, Scripps Clinic, Joslin Diabetes Center, University of Maryland, University of Arizona, and Temple.

49 patients with type 1 diabetes and chronic kidney disease were randomized into treatment and control groups in an 18 month study. Treatment group (APS) patients had a statistically significant improvement in renal function as compared to the control group.

The purpose of the study was to obtain independent collaboration of the extraordinary results obtained in the first nephropathy study. This pivotal study did not include the original APS sites.

Effect of intensive insulin therapy on progression of overt diabetic nephropathy in patients with IDDM. Endocrine Practice (1999) 5:174-178.