Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284232
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Randomized Controlled Trial Studying the Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
Study Start Date : October 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HbA1c % [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Hypoclycemic events [ Time Frame: 9 months ]
  2. Measurement quality of blood glucose instrument [ Time Frame: 9 months ]
  3. Frequency of SMBG [ Time Frame: 9 months ]
  4. Satisfaction [ Time Frame: 9 months ]
  5. New learning points for patients [ Time Frame: 9 months ]
  6. Confidence in new instrument quality [ Time Frame: 9 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284232


Locations
Layout table for location information
Norway
Stavanger University Hospital
Stavanger, Norway
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Layout table for investigator information
Principal Investigator: Svein Skeie, MD PhD Stavanger Health Research
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00284232    
Other Study ID Numbers: Measure 2004
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by Helse Stavanger HF:
HbA1c
Self-monitoring blood glucose (SMBG)
Diabetes treatment
quality of care
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs