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NCT Number: NCT00284232

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stavanger University Hospital

Stavanger, Norway

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use and interpretation of blood glucose results

Behavioral

Insulin dosing based on SMBG chart and education

Drug

Primary outcomes

  1. HbA1c %

    Time frame: 9 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 31, 2006
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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