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OpenTrials
Completed

NCT Number: NCT00824148

Use of Real-time Continuous Glucose Monitoring System 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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, St. Olavs Hospital

Trondheim, N-7006, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guardian REAL-Time Continuous Glucose Monitoring System

Device

One group will use the glucose monitoring system for 1 month

Conventional self-monitoring of plasma glucose

Other

Finger prick blood glucose measurements

Primary outcomes

  1. Level of HbA1c concentration

    Time frame: 1 and 3 months post intervention.

Secondary outcomes

  1. Quality of life assessed by SF-36, DTSQs and DTSQc

    Time frame: 1 and 3 months post intervention

  2. Number of hypoglycemic events

    Time frame: 1 and 3 months post intervention

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Norwegian Diabetes Association

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 16, 2009
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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