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

NCT ID: NCT00284232

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2006-12-31

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

Use and interpretation of blood glucose results

Intervention Type: BEHAVIORAL

Insulin dosing based on SMBG chart and education

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Svein Skeie, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Stavanger Health Research

Locations

Stavanger University Hospital

Stavanger, , Norway

Countries

Norway

Other Identifiers

Measure 2004

Identifier Type: -

Identifier Source: org_study_id