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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Guardian REAL-Time Continuous Glucose Monitoring System

Intervention Type DEVICE

One group will use the glucose monitoring system for 1 month

Self-monitoring of plasma glucose

Conventional self-monitoring of plasma glucose by finger-prick sampling for 1 month, followed by 1 month observation.

Group Type ACTIVE_COMPARATOR

Conventional self-monitoring of plasma glucose

Intervention Type OTHER

Finger prick blood glucose measurements

Interventions

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Guardian REAL-Time Continuous Glucose Monitoring System

One group will use the glucose monitoring system for 1 month

Intervention Type DEVICE

Conventional self-monitoring of plasma glucose

Finger prick blood glucose measurements

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No