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

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.

• 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.

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