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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014