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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824148
• Other study ID #: 4.2008.1607
• Secondary ID: 19637
• Status: Completed
• Phase: N/A
• First received: January 15, 2009
• Last updated: February 23, 2017
• Start date: January 2009
• Est. completion date: September 2009

Study information

• Verified date: February 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Guardian REAL-Time Continuous Glucose Monitoring System
One group will use the glucose monitoring system for 1 month

Other:
• Conventional self-monitoring of plasma glucose
Finger prick blood glucose measurements

Locations

Country	Name	City	State
Norway	Department of Endocrinology, St. Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Norwegian Diabetes Association

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Langeland LB, Salvesen O, Selle H, Carlsen SM, Fougner KJ. Short-term continuous glucose monitoring: effects on glucose and treatment satisfaction in patients with type 1 diabetes mellitus; a randomized controlled trial. Int J Clin Pract. 2012 Aug;66(8):7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of HbA1c concentration		1 and 3 months post intervention.
Secondary	Quality of life assessed by SF-36, DTSQs and DTSQc		1 and 3 months post intervention
Secondary	Number of hypoglycemic events		1 and 3 months post intervention