Diabetes Mellitus, Type 1
Conditions
Keywords
HbA1c, Self-monitoring blood glucose (SMBG), Diabetes treatment, quality of care
Brief 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.
Detailed 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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c % | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| New learning points for patients | 9 months |
| Confidence in new instrument quality | 9 months |
| Satisfaction | 9 months |
| Measurement quality of blood glucose instrument | 9 months |
| Frequency of SMBG | 9 months |
| Hypoclycemic events | 9 months |
Countries
Norway