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

Norwegian University of Science and Technology1 site in 1 country30 target enrollmentJanuary 2009

ConditionsDiabetes Mellitus, Type 1

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 1
Sponsor: Norwegian University of Science and Technology
Enrollment: 30
Locations: 1
Primary Endpoint: Level of HbA1c concentration
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

September 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Norwegian University of Science and Technology

Responsible Party

Sponsor

Eligibility 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 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

•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.