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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00284232
Enrollment
140
Registered
2006-01-31
Start date
2004-10-31
Completion date
2006-12-31
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

HbA1c, Self-monitoring blood glucose (SMBG), Diabetes treatment, quality of care

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.

Interventions

BEHAVIORALUse and interpretation of blood glucose results
DRUGInsulin dosing based on SMBG chart and education

Sponsors

Helse Stavanger HF
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
HbA1c %9 months

Secondary

MeasureTime frame
New learning points for patients9 months
Confidence in new instrument quality9 months
Satisfaction9 months
Measurement quality of blood glucose instrument9 months
Frequency of SMBG9 months
Hypoclycemic events9 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026