Effect of CSII and CGM on Progression of Late Diabetic Complications

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Steno Diabetes Center
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Steen Andersen, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT01454700
First received: October 17, 2011
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Type 1 Diabetes Mellitus
Device: Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)
Other: Multiple daily insulin injections (MDI)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • difference in change in urine albumine excretion from baseline to end of study (12 months) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Urine albumin excretion is evaluated at screening, at entry, after 1,3,6,9, and 12 months.


Secondary Outcome Measures:
  • difference in change of HbA1c from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • difference in change of 24-hour blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • difference in change of glomerular filtration rate (GFR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • difference in the occurence or progression of retinopathy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • difference in endothelial cell dysfunction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • difference in carotid intima media thickness (CIMT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CSII plus CGM
12 months with insulin pump therapy plus continuous glucose monitoring
Device: Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)
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 Other: Multiple daily insulin injections (MDI)
12 months therapy with MDI
Other Names:
  • Human insulin
  • Insulin analogues

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454700

Contacts
Contact: Steen Andersen, MD, DMSc +45 3075-7056 stan@steno.dk
Contact: Signe Rosenlund, MD +45 3079-8832 svr@steno.dk

Locations
Denmark
Steno Diabetes Center Recruiting
Gentofte, Copenhagen, Denmark, 2820
Contact: Steen Andersen, MD, DMSc    +45 3075-7056    stan@steno.dk   
Contact: Signe Rosenlund, MD    +45 3079-8832    svr@steno.dk   
Principal Investigator: Steen Andersen, MD, DMSc         
Sponsors and Collaborators
Steen Andersen
Medtronic
Investigators
Principal Investigator: Steen Andersen, MD, DMSc Steno Diabetes Center
  More Information

No publications provided

Responsible Party: Steen Andersen, Chief physician, DMSc, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT01454700     History of Changes
Other Study ID Numbers: H-3-2011-122
Study First Received: October 17, 2011
Last Updated: November 19, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Steno Diabetes Center:
Type 1 diabetes mellitus
Albuminuria
Late diabetes complications
CSII
CGM
Glycaemic control

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

ClinicalTrials.gov processed this record on August 28, 2014