Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
This study has been completed.
Sponsor:
Helse Stavanger HF
Information provided by:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00284232
First received: January 27, 2006
Last updated: July 21, 2010
Last verified: January 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 1 |
Behavioral: Use and interpretation of blood glucose results Drug: Insulin dosing based on SMBG chart and education |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Randomized Controlled Trial Studying the Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Dextrose
U.S. FDA Resources
Further study details as provided by Helse Stavanger HF:
Primary Outcome Measures:
- HbA1c %
Secondary Outcome Measures:
- Hypoclycemic events
- Measurement quality of blood glucose instrument
- Frequency of SMBG
- Satisfaction
- New learning points for patients
- Confidence in new instrument quality
| Estimated Enrollment: | 140 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | August 2006 |
- 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00284232 History of Changes |
| Other Study ID Numbers: | Measure 2004 |
| Study First Received: | January 27, 2006 |
| Last Updated: | July 21, 2010 |
| Health Authority: | Norway: Ministry of Education and Reseach |
Keywords provided by Helse Stavanger HF:
|
HbA1c Self-monitoring blood glucose (SMBG) Diabetes treatment quality of care |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013