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

This study has been completed.
Sponsor:
Collaborator:
Norwegian Diabetes Association
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00824148
First received: January 15, 2009
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 1
 Device: Guardian REAL-Time Continuous Glucose Monitoring System
Other: Conventional self-monitoring of plasma glucose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Real-time Continuous Glucose Monitoring System to Control Blood Glucose in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Level of HbA1c concentration [ Time Frame: 1 and 3 months post intervention. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life assessed by SF-36, DTSQs and DTSQc [ Time Frame: 1 and 3 months post intervention ] [ Designated as safety issue: No ]
  • Number of hypoglycemic events [ Time Frame: 1 and 3 months post intervention ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Guardian REAL-Time Continuous glucose monitoring system
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824148

Locations
Norway
Department of Endocrinology, St. Olavs Hospital
Trondheim, Norway, N-7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Norwegian Diabetes Association
Investigators
Principal Investigator: Kristian J Fougner, MD Departement of Endocrinology St. Olavs Hospital
  More Information

Publications:

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00824148     History of Changes
Other Study ID Numbers: 4.2008.1607, 19637
Study First Received: January 15, 2009
Last Updated: July 25, 2012
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
Real-time glucose monitoring system
HbA1c
Quality of life
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013