Effect of CSII and CGM on Progression of Late Diabetic Complications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01454700
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : January 14, 2015
Information provided by (Responsible Party):
Steen Andersen, Steno Diabetes Center

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

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

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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
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
Other Names:
  • CSII
  • CGM
  • Medtronic MiniMed Paradigm REAL-Time System
  • Medtronic MiniMed Paradigm Veo
  • Sensor augmented insulin pump therapy
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
Other Names:
  • Human insulin
  • Insulin analogues

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. difference in change of HbA1c from baseline to 12 months [ Time Frame: 12 months ]
  2. difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles [ Time Frame: 12 months ]
  3. difference in change of 24-hour blood pressure [ Time Frame: 12 months ]
  4. difference in change of glomerular filtration rate (GFR) [ Time Frame: 12 months ]
  5. difference in the occurence or progression of retinopathy [ Time Frame: 12 months ]
  6. difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP [ Time Frame: 12 months ]
  7. difference in endothelial cell dysfunction [ Time Frame: 12 months ]
  8. difference in carotid intima media thickness (CIMT) [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01454700

Steno Diabetes Center
Gentofte, Copenhagen, Denmark, 2820
Sponsors and Collaborators
Steen Andersen
Principal Investigator: Steen Andersen, MD, DMSc Steno Diabetes Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steen Andersen, Chief physician, DMSc, Steno Diabetes Center Identifier: NCT01454700     History of Changes
Other Study ID Numbers: H-3-2011-122
First Posted: October 19, 2011    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

Keywords provided by Steen Andersen, Steno Diabetes Center:
Type 1 diabetes mellitus
Late diabetes complications
Glycaemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs