Use of Real-time Continuous Glucose Monitoring System in Patients With Type 1 Diabetes Mellitus

February 23, 2017 updated by: Norwegian University of Science and Technology

Use of Real-time Continuous Glucose Monitoring System to Control Blood Glucose in Patients With Type 1 Diabetes Mellitus

The purpose of this study is to determine whether a real-time continuous glucose monitoring system is able to improve HbA1c in patients suffering from type 1 diabetes compared to conventional finger prick glucose measurements. In addition it will investigate whether number of episodes with serious hypoglycemia is changed in those same patients, and whether quality of life (health status and treatment satisfaction) increases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • Norway
      • Trondheim, Norway, N-7006
        • Department of Endocrinology, St. Olavs Hospital

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diabetes Mellitus, Type 1 > 3 years.
  2. For practical reasons patients should live in Trondheim, Malvik, Melhus or Klæbu.
  3. Level of HbA1c (measured by DCA 2000) between 7 and 10 % and/or experience blood glucose < 3 mmol/L (verified by finger-prick measurement) at least once a week and/or at least one episode with serious hypoglycemia the previous half a year.(Defined as need of help from others)
  4. Only patients who use insulin pumps or multi-injection regime (=3 daily injections with short term acting insulin or insulin analogue + at lest one daily injection with NPH-insulin or long term acting insulin analogue.

Exclusion Criteria:

  1. Patients with other diseases such as untreated hypothyroidism, adrenal gland failure, celiac disease, renal failure, unstable coronary heart disease, serious psychiatric disorder, or mental retardation.
  2. Patients who are not able to learn how to use the continuous glucose monitoring system given a reasonable amount of effort.
  3. Patients who are not able to do the glucose measurements, insulin dose change and diary notes which the study demands.
  4. Unsuited for participating from any other cause.

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real-time glucose monitoring
Use of Guardian REAL-Time Continuous Glucose Monitoring System, (Medtronic Minimed, Northridge, CA) for 1 month, followed by observation for 2 months.
Device: Guardian REAL-Time Continuous Glucose Monitoring System
One group will use the glucose monitoring system for 1 month
Active Comparator: Self-monitoring of plasma glucose
Conventional self-monitoring of plasma glucose by finger-prick sampling for 1 month, followed by 1 month observation.
Other: Conventional self-monitoring of plasma glucose
Finger prick blood glucose measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of HbA1c concentration
Time Frame: 1 and 3 months post intervention.
1 and 3 months post intervention.

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life assessed by SF-36, DTSQs and DTSQc
Time Frame: 1 and 3 months post intervention
1 and 3 months post intervention
Number of hypoglycemic events
Time Frame: 1 and 3 months post intervention
1 and 3 months post intervention

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

Collaborators

Norwegian Diabetes Association

Investigators

  • Principal Investigator: Kristian J Fougner, MD, Departement of Endocrinology St. Olavs Hospital

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 (Actual)

January 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimate)

January 16, 2009

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.2008.1607
  • 19637 (Other Identifier: NSD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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