Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial Studying the Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: Use and interpretation of blood glucose results
* Drug: Insulin dosing based on SMBG chart and education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Use and interpretation of blood glucose results|nan|
|Drug: Insulin dosing based on SMBG chart and education|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c % |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoclycemic events |  | 9 months | 
| Measurement quality of blood glucose instrument |  | 9 months | 
| Frequency of SMBG |  | 9 months | 
| Satisfaction |  | 9 months | 
| New learning points for patients |  | 9 months | 
| Confidence in new instrument quality |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HbA1c, Self-monitoring blood glucose (SMBG), Diabetes treatment, quality of care