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Diabetes Mellitus, Type 1Phase 4NCT00284232

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

A Phase 4 study testing Use and interpretation of blood glucose results and Insulin dosing based on SMBG chart and education in people with Diabetes Mellitus, Type 1, run by Helse Stavanger HF at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Use and interpretation of blood glucose results and Insulin dosing based on SMBG chart and education
How many people
140 participants
Where
1 siteNorway
Study dates
Oct 2004to Dec 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Hypoglycemia unawareness
  • Mental incapacity

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Stavanger University Hospital

    Stavanger

Other trials in Norway

About this study

Official title: Randomized Controlled Trial Studying the 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.

Read the 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.
Being tested
Use and interpretation of blood glucose results, Insulin dosing based on SMBG chart and education
Keywords
HbA1c, Self-monitoring blood glucose (SMBG), Diabetes treatment, quality of care
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use and interpretation of blood glucose resultsBehavioural

  • Insulin dosing based on SMBG chart and educationDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c %

    Measured: 9 months

Secondary outcomes (6)

  1. Hypoclycemic events

    Measured: 9 months

  2. Measurement quality of blood glucose instrument

    Measured: 9 months

  3. Frequency of SMBG

    Measured: 9 months

  4. Satisfaction

    Measured: 9 months

  5. New learning points for patients

    Measured: 9 months

  6. Confidence in new instrument quality

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2006 (estimated)
  2. Study startOct 2004
  3. Primary completionAug 2006
  4. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00284232
Sponsor's protocol ID
Measure 2004
Status last verified
Jul 2015
First submitted
27 Jan 2006
Last updated
28 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Use and interpretation of blood glucose results and Insulin dosing based on SMBG chart and education in people with Diabetes Mellitus, Type 1, run by Helse Stavanger HF at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c % (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00284232.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.

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