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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Guardian REAL-Time Continuous Glucose Monitoring System
Conventional self-monitoring of plasma glucose
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Real-time glucose monitoring system, HbA1c, Quality of life, Hypoglycemia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Endocrinology, St. Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Real-time glucose monitoring

Self-monitoring of plasma glucose

Arm Description

Use of Guardian REAL-Time Continuous Glucose Monitoring System, (Medtronic Minimed, Northridge, CA) for 1 month, followed by observation for 2 months.

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

Outcomes

Primary Outcome Measures

Level of HbA1c concentration

Secondary Outcome Measures

Quality of life assessed by SF-36, DTSQs and DTSQc
Number of hypoglycemic events

Full Information

First Posted
January 15, 2009
Last Updated
February 23, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT00824148
Brief Title
Use of Real-time Continuous Glucose Monitoring System in Patients With Type 1 Diabetes Mellitus
Official Title
Use of Real-time Continuous Glucose Monitoring System to Control Blood Glucose in Patients With Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Diabetes Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Real-time glucose monitoring system, HbA1c, Quality of life, Hypoglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real-time glucose monitoring
Arm Type
Experimental
Arm Description
Use of Guardian REAL-Time Continuous Glucose Monitoring System, (Medtronic Minimed, Northridge, CA) for 1 month, followed by observation for 2 months.
Arm Title
Self-monitoring of plasma glucose
Arm Type
Active Comparator
Arm Description
Conventional self-monitoring of plasma glucose by finger-prick sampling for 1 month, followed by 1 month observation.
Intervention Type
Device
Intervention Name(s)
Guardian REAL-Time Continuous Glucose Monitoring System
Intervention Description
One group will use the glucose monitoring system for 1 month
Intervention Type
Other
Intervention Name(s)
Conventional self-monitoring of plasma glucose
Intervention Description
Finger prick blood glucose measurements
Primary Outcome Measure Information:
Title
Level of HbA1c concentration
Time Frame
1 and 3 months post intervention.
Secondary Outcome Measure Information:
Title
Quality of life assessed by SF-36, DTSQs and DTSQc
Time Frame
1 and 3 months post intervention
Title
Number of hypoglycemic events
Time Frame
1 and 3 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian J Fougner, MD
Organizational Affiliation
Departement of Endocrinology St. Olavs Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
N-7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22805265
Citation
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):741-747. doi: 10.1111/j.1742-1241.2012.02947.x.
Results Reference
result

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

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