Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00284232
NCT00284232CompletedPhase 4

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

Helse Stavanger HF1 site in 1 country140 target enrollmentStarted: October 1, 2004Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
140
Locations
1
Primary Endpoint
HbA1c %
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

HbA1c %

Time Frame: 9 months

Secondary Outcomes

  • Frequency of SMBG(9 months)
  • New learning points for patients(9 months)
  • Confidence in new instrument quality(9 months)
  • Measurement quality of blood glucose instrument(9 months)
  • Satisfaction(9 months)
  • Hypoclycemic events(9 months)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Glycemic and Metabolic Responses of Frozen Yogurt Containing Saskatoon Berry Powder in Healthy Males and FemalesHealthy
NCT02571114University of Manitoba13
Completed
Early Phase 1
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 DiabetesType 1 Diabetes Mellitus With Hypoglycemia
NCT04712266Abvance Therapeutics15
Recruiting
Phase 1
Regulation of Brain Glucose Metabolism in Type 1 DiabetesHypoglycemia UnawarenessDiabetes Mellitus, Type 1
NCT05317455Yale University16
Completed
Not Applicable
The Effects of a Ruminococcus Torques Strain Bacterium in Healthy Adults.HealthyOverweight
NCT05448274Oluf Pedersen32
Not yet recruiting
Not Applicable
Low cArbohydraTe dIeT and aUtomated Insulin Delivery System for Type 1 DiabetEsType 1 Diabetes
NCT05449678Institut de Recherches Cliniques de Montreal38