Effect of CSII and CGM on Progression of Late Diabetic Complications
|ClinicalTrials.gov Identifier: NCT01454700|
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : January 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM) Other: Multiple daily insulin injections (MDI)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2011|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
Experimental: CSII plus CGM
Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring.
Device: Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)
Randomization to 12 months with CSII plus CGM
Active Comparator: Multiple daily insulin injections
randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen).
Other: Multiple daily insulin injections (MDI)
Randomization12 months therapy with MDI
- difference in change in urine albumine excretion from baseline to end of study (12 months) [ Time Frame: 12 months ]Urine albumin excretion is evaluated at screening, at entry, after 1,3,6,9, and 12 months.
- difference in change of HbA1c from baseline to 12 months [ Time Frame: 12 months ]
- difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles [ Time Frame: 12 months ]
- difference in change of 24-hour blood pressure [ Time Frame: 12 months ]
- difference in change of glomerular filtration rate (GFR) [ Time Frame: 12 months ]
- difference in the occurence or progression of retinopathy [ Time Frame: 12 months ]
- difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP [ Time Frame: 12 months ]
- difference in endothelial cell dysfunction [ Time Frame: 12 months ]
- difference in carotid intima media thickness (CIMT) [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454700
|Steno Diabetes Center|
|Gentofte, Copenhagen, Denmark, 2820|
|Principal Investigator:||Steen Andersen, MD, DMSc||Steno Diabetes Center|