Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT00284232
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.
Study:
NCT00284232
Study Brief:
Protocol Section:
NCT00284232