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Effect of CSII and CGM on Progression of Late Diabetic Complications Phase 4 60

Completed
Clinical Trial NCT01454700 was designed to study Treatment for Type 1 Diabetes Mellitus. This was a Phase 4 interventional study that is now completed. The study started on December 1, 2011, with plans to enroll 60 participants. Led by Steen Andersen, the expected completion date was December 1, 2014. The latest data from ClinicalTrials.gov was last updated on January 14, 2015.
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 progression of albuminuria in patients with type 1 diabetes
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 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 rec...

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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

Conditions
Type 1 Diabetes Mellitus
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • H-3-2011-122
NCT ID Number
NCT01454700
Start Date (Actual)
2011-12
Last Update Posted
2015-01-14
Completion Date (Estimated)
2014-12
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 4
Status
Completed
Keywords
Type 1 diabetes mellitus
Albuminuria
Late diabetes complications
CSII
CGM
Glycaemic control
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCSII plus CGM
Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring.
Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)
Randomization to 12 months with CSII plus CGM
Active ComparatorMultiple daily insulin injections
randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen).
Multiple daily insulin injections (MDI)
Randomization12 months therapy with MDI
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
difference in change in urine albumine excretion from baseline to end of study (12 months)
Urine albumin excretion is evaluated at screening, at entry, after 1,3,6,9, and 12 months.
12 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
difference in change of HbA1c from baseline to 12 months
12 months
difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles
12 months
difference in change of 24-hour blood pressure
12 months
difference in change of glomerular filtration rate (GFR)
12 months
difference in the occurence or progression of retinopathy
12 months
difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP
12 months
difference in endothelial cell dysfunction
12 months
difference in carotid intima media thickness (CIMT)
12 months
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Steen Andersen logoSteen Andersen
Medtronic logoMedtronic
Study Responsible Party
Steen Andersen, Sponsor-Investigator, Chief physician, DMSc, Steno Diabetes Center Copenhagen
No contact data.
1 Study Locations in 1 Countries

Copenhagen

Steno Diabetes Center, Gentofte Municipality, Copenhagen, 2820, Denmark