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

Helse Stavanger HF

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Insulin dosing based on SMBG chart and education

Behavioral: Use and interpretation of blood glucose results

Study type

Interventional

Funder types

Other

Identifiers

NCT00284232

Measure 2004

Details and patient eligibility

About

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.

Full 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.