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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Randomized Controlled Trial Studying the Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284232
• Other study ID #: Measure 2004
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2006
• Last updated: July 27, 2015
• Start date: October 2004
• Est. completion date: December 2006

Study information

• Verified date: July 2015
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Use and interpretation of blood glucose results

Drug:
• Insulin dosing based on SMBG chart and education

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c %		9 months	No
Secondary	Hypoclycemic events		9 months	No
Secondary	Measurement quality of blood glucose instrument		9 months	No
Secondary	Frequency of SMBG		9 months	No
Secondary	Satisfaction		9 months	No
Secondary	New learning points for patients		9 months	No
Secondary	Confidence in new instrument quality		9 months	No