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

This study has been completed.
Sponsor:
Information provided by:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00284232
First received: January 27, 2006
Last updated: July 21, 2010
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Behavioral: Use and interpretation of blood glucose results
Drug: Insulin dosing based on SMBG chart and education
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomized Controlled Trial Studying the Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • HbA1c %

Secondary Outcome Measures:
  • Hypoclycemic events
  • Measurement quality of blood glucose instrument
  • Frequency of SMBG
  • Satisfaction
  • New learning points for patients
  • Confidence in new instrument quality

Estimated Enrollment: 140
Study Start Date: October 2004
Estimated Study Completion Date: August 2006
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284232

Locations
Norway
Stavanger University Hospital
Stavanger, Norway
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Principal Investigator: Svein Skeie, MD PhD Stavanger Health Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00284232     History of Changes
Other Study ID Numbers: Measure 2004
Study First Received: January 27, 2006
Last Updated: July 21, 2010
Health Authority: Norway: Ministry of Education and Reseach

Keywords provided by Helse Stavanger HF:
HbA1c
Self-monitoring blood glucose (SMBG)
Diabetes treatment
quality of care

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014