Status:
COMPLETED
Effect of CSII and CGM on Progression of Late Diabetic Complications
Lead Sponsor:
Steen Andersen
Collaborating Sponsors:
Medtronic
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 progressio...
Detailed Description
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 injectio...
Eligibility Criteria
Inclusion
- 18-75 years of age,
- Type 1 diabetes according to WHO criteria,
- Urin albumine \> 30 mg/g (albumine/creatinine ratio),
- HbA1c \> 7.5 \< 13.0%,
- No change in RAAS blocking treatment at least 4 weeks prior to screening.
Exclusion
- Kidney disease other that diabetic nephropathy,
- Recurrence of severe hypoglycaemia or hypoglycaemia unawareness as judged by the investigator,
- Use of insulin pump within 12 months,
- Acute myocardial infarction within 3 months,
- Severe arteriosclerosis as judged by the investigator,
- Heart failure (NYHA class 3 or 4),
- Abuse of alcohol or drugs,
- Any cancer diagnosis unless in remission at least 5 years prior to screening,
- Participation in other intervention studies,
- Pregnant or lactating women,
- Any other disease, condition or type of treatment which - as judged by the investigator - render the patient ineligible to participate in the study.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01454700
Start Date
December 1 2011
End Date
December 1 2014
Last Update
January 14 2015
Active Locations (1)
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1
Steno Diabetes Center
Gentofte Municipality, Copenhagen, Denmark, 2820