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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Guardian REAL-Time Continuous Glucose Monitoring System
* Other: Conventional self-monitoring of plasma glucose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-time glucose monitoring<br>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<br>* One group will use the glucose monitoring system for 1 month<br>|
| Active Comparator: Self-monitoring of plasma glucose<br>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<br>* Finger prick blood glucose measurements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of HbA1c concentration |  | 1 and 3 months post intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real-time glucose monitoring system, HbA1c, Quality of life, Hypoglycemia