NCT00284232

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (planned)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
BEHAVIORAL	Use and interpretation of blood glucose results
DRUG	Insulin dosing based on SMBG chart and education

Timeline

• Start date: 2004-10-01
• Primary completion: 2006-08-01
• Completion: 2006-12-01
• First posted: 2006-01-31
• Last updated: 2015-07-28

Locations

1 site across 1 country: Norway