- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00284232
Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
July 27, 2015 updated by: Helse Stavanger HF
Randomized Controlled Trial Studying the Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
A randomized controlled trial in patients with type 1 diabetes, assessing the metabolic effects of accurate blood sugar results and education.
A systematic approach in self-monitoring blood glucose will improve metabolic control in type 1 diabetes patients.
Education in SMBG combined with a high analytical quality instrument for SMBG, introduced in a systematic and thorough way will improve HbA1c by 0,5% and keep it over a period of 9 months.
Study Overview
Status
Completed
Conditions
Detailed Description
- Written informed consent 130 patients with type 1 diabetes to be included
- age 18-70
- HbA1c of 8% or higher, variation in HbA1c over the last 18 months sholuld be <1,5%
- Treated with multiple insulin injections or insulin pumps
- Variation in weight less than 5kg within last year
- Using SMBG on a daily basis
- Mental capacity and stability to participate
- No hypoglycemia unawareness
- No likelihood that patient will drop out or not perform according to protocol
- Continious recruitment from the outpatient clinic at Stavanger University Hospital from October 2004-October 2005
- 9 months follow-up
- Possible 12 month extension after initial
- Intervention group receives new SMBG instrument, education and advice on treatment changes at baseline, 1,2,3,6 and 9 months. Control group continues regular care following national guidelines of Norway. This includes visits usually every 3-6 months at the outpatient clinic and possibly with their GP in addition.
Study Type
Interventional
Enrollment
140
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Stavanger, Norway
- Stavanger University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hba1c 8% or higher, less than 1,5% variation within last year
- Age 18-70
- Multiinjections or insulin pumps
- Stable weight (<5kg variation last year)
- Mentally stable
Exclusion Criteria:
- Hypoglycemia unawareness
- Mental incapacity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c %
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hypoclycemic events
Time Frame: 9 months
|
9 months
|
Measurement quality of blood glucose instrument
Time Frame: 9 months
|
9 months
|
Frequency of SMBG
Time Frame: 9 months
|
9 months
|
Satisfaction
Time Frame: 9 months
|
9 months
|
New learning points for patients
Time Frame: 9 months
|
9 months
|
Confidence in new instrument quality
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Svein Skeie, MD PhD, Stavanger Health Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
January 27, 2006
First Submitted That Met QC Criteria
January 27, 2006
First Posted (Estimate)
January 31, 2006
Study Record Updates
Last Update Posted (Estimate)
July 28, 2015
Last Update Submitted That Met QC Criteria
July 27, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Measure 2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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