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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Guardian REAL-Time Continuous Glucose Monitoring System; Other: Conventional self-monitoring of plasma glucose

• Registration Number: NCT00824148
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-16
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Real-time glucose monitoring	Guardian REAL-Time Continuous Glucose Monitoring System	Use of Guardian REAL-Time Continuous Glucose Monitoring System, (Medtronic Minimed, Northridge, CA) for 1 month, followed by observation for 2 months.
Self-monitoring of plasma glucose	Conventional self-monitoring of plasma glucose	Conventional self-monitoring of plasma glucose by finger-prick sampling for 1 month, followed by 1 month observation.

Primary Outcome Measures

Name	Time	Method
Level of HbA1c concentration	1 and 3 months post intervention.

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed by SF-36, DTSQs and DTSQc	1 and 3 months post intervention
Number of hypoglycemic events	1 and 3 months post intervention

Trial Locations

Locations (1)

Department of Endocrinology, St. Olavs Hospital; 🇳🇴 Trondheim, Norway