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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00284232
Study type Interventional
Source Helse Stavanger HF
Contact
Status Completed
Phase Phase 4
Start date October 2004
Completion date December 2006
View Details
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