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

This study is not yet open for participant recruitment.

Verified by Norwegian University of Science and Technology, January 2009

First Received: January 15, 2009 Last Updated: January 16, 2009 History of Changes

Sponsors and Collaborators:	Norwegian University of Science and Technology Norwegian Diabetes Association
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00824148

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 increases.

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

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Use of Real-Time Continuous Glucose Monitoring System to Control Blood Glucose in Patients With Type 1 Diabetes Mellitus

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 ]

Estimated Enrollment:	30
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Real-time glucose monitoring: Experimental 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
Self-monitoring of plasma glucose: Active Comparator 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:

Diabetes Mellitus, Type 1 > 3 years.
For practical reasons patients should live in Trondheim, Malvik, Melhus or Klæbu.
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)
Only patients who use insulinpumps or multiinjection regime (=3 daily injections with shortterm acting insulin or insulin analogue + at lest one daily injection with NPH-insulin or longterm acting insulin analogue.

Exclusion Criteria:

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.
Patients who are not able to learn how to use the continuous glucose monitoring system given a reasonable amount of effort.
Patients who are not able to do the glucose measurements, insulin dose change and diary notes which the study demands.
Unsuited for participating from any other cause.

Contacts and Locations

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

Contacts

Contact: KRISTIAN J FOUGNER	+4773867536	Kristian.Fougner@stolav.no
Contact: LINE BRITT L LANGELAND	+4791813160	linebrit@stud.ntnu.no

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

No publications provided

Responsible Party:	Department of Endocrinology, St. Olavs Hospital ( Kristian J. Fougner, MD, Head of Department )
Study ID Numbers:	4.2008.1607, NSD-19637
Study First Received:	January 15, 2009
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00824148 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway

Keywords provided by Norwegian University of Science and Technology:

Real-time glucose monitoring system
HbA1c
Quality of life
Hypoglycemia

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Quality of Life
Endocrine System Diseases

Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Hypoglycemia
Metabolic Disorder

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009