Type 1 Diabetes Mellitus Clinical Trial
Official title:
The Effect of Sensor-Augmented Continuous Subcutaneous Insulin Infusion Compared to Multiple Daily Insulin Injections in Prevention of Increasing Urinary Albumin Excretion Rate in Type 1 Diabetes Mellitus
The purpose of the study is to investigate whether the combination of insulin pump therapy and continued glucose monitoring (CGM) is superior to multiple daily insulin injections to prevent progression of albuminuria in patients with type 1 diabetes
80 type 1 diabetic patients with kidney function (GFR > 45 ml/min), but with urine albumin
excretion of at least 30 mg/day and HbA1c 7.5-13.0% are randomised to either multiple daily
insulin injections (control group) or insulin pump therapy plus continued glucose monitoring
(CGM) (intervention group). Patients must be in stable RAAS blockade before entering the
study.
Before the study is initiated all patients receive education in intensive diabetes treatment
and self-care including carbohydrate counting.
Patients return to the clinic after 1,3,6,9, and 12 months for measurement of urine albumine
excretion, clinical examination including blood pressure, CGM sensor readings, four-point
self monitored blood glucose (SMBG) profiles, blood samples and fulfillment of questionnaire
to assess quality of life. At entry and after 12 months, eye fundus foto, 24-hour blood
pressure, GFR, and carotis intima media thickness (CIMT)are also evaluated.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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