Effect of CSII and CGM on Progression of Late Diabetic Complications

January 13, 2015 updated by: Steen Andersen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Gentofte, Copenhagen, Denmark, 2820
        • Steno Diabetes center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • CGM
  • CSII
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steen Andersen

Collaborators

Medtronic

Investigators

  • Principal Investigator: Steen Andersen, MD, DMSc, Steno Diabetes Center Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 17, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2011-122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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