NCT00284232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

January 27, 2006

Last Update Submit

July 27, 2015

Conditions

Diabetes Mellitus, Type 1

Keywords

HbA1cSelf-monitoring blood glucose (SMBG)Diabetes treatmentquality of care

Outcome Measures

Primary Outcomes (1)

  • HbA1c %

    9 months

Secondary Outcomes (6)

  • Hypoclycemic events

    9 months

  • Measurement quality of blood glucose instrument

    9 months

  • Frequency of SMBG

    9 months

  • Satisfaction

    9 months

  • New learning points for patients

    9 months

  • +1 more secondary outcomes

Interventions

Use and interpretation of blood glucose resultsBEHAVIORAL
Insulin dosing based on SMBG chart and educationDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hypoglycemia unawareness
  • Mental incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, Norway

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Svein Skeie, MD PhD

    Stavanger Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 31, 2006

Study Start

October 1, 2004

Primary Completion

August 1, 2006

Study Completion

December 1, 2006

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

NO(1)