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Type 2 DiabetesPhase 4NCT00688363

Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

A Phase 4 study testing weekly blood glucose profile and three-monthly haemoglobin A1c in people with Type 2 Diabetes, run by Deutsche Diabetes Gesellschaft at 41 sites in Germany.

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

The purpose of this randomized, prospective trial is to determine wether (a) a once weekly glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated haemoglobin are effective interventions to improve HbA1c after one year in typ 2-diabetic patients on conventional insulin treatment. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
weekly blood glucose profile and three-monthly haemoglobin A1c
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
41 sitesGermany
Study dates
Feb 2003to Dec 2008
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2-diabetes (ADA/WHO-Criteria)
  • Conventional insulin therapy ( 1-3 daily injections of basal- and/or mixed insulin also in combination with oral agents.)
  • Age:> 40 years
  • BMI:> 20 kg/m²

Who cannot join

  • Impaired liver function, defined as > 2 times upper limit of normal
  • Impaired renal function defined liver enzymes as serum-creatinine > 1.3 mg/dl
  • Gastro-intestinal diseases (disturbances, diagnoses)
  • Inability to perform study-related activities according to the present protocol
  • Pregnancy not certainly excluded
  • Abuse of alcohol and/or other drugs
Show all 10Show fewer
  • Participation in other clinical trials during the past 3 month
  • Threat to general state of health
  • Intensified insulin therapy (at least 3 times rapid-acting insulin)
  • Frequent blood glucose self monitoring during the past 3 months (more than one 4-point glucose profile per week or more than one blood glucose/ urinary glucose test per day )

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

Germany41 sites

  • Koch, Peter

    Bad Harzburg, 38667

  • Maxeiner, Stefan

    Bad Kreuznach, 55545

  • Diabeteszentrum Bad Lauterberg

    Bad Lauterberg im Harz, Lower Saxony, D-37431

  • Friedrichs, Michael

    Bad Lauterberg im Harz, 37431

  • Jödicke, Carmen

    Bad Lauterberg im Harz, 37431

  • Mulch-Wiemer, Christa

    Bad Nauheim, 61231

  • Bellmann, Renate

    Berlin, 10365

  • Schoch, Daniela

    Berlin, 13055

  • Warmers, Ulrike

    Bitburg, 54634

  • Leupold, Manfred

    Borna, 04552

  • Kamke, Wolfram

    Burg/Sreewald, 03096

  • Hildebrandt, Rüdiger

    Clausthal-Zellerfeld, 38678

  • Lemmerhirt, Jürgen

    Cuxhaven, 27474

  • Preuß, Uwe

    Datteln, 45711

  • Weller, Ulrich

    Dorsten, 46282

  • Fischer, Harald

    Düren, 52351

  • Krege, Peter

    Emsdetten, 48282

  • Gölz, Stefan

    Esslingen am Neckar, 73728

  • Wollersen, Karin

    Freiburg im Breisgau, 79106

  • Hendel, Andreas

    Grassau, 83224

  • Pfeiffer, Martha

    Gronau, 48559

  • Jäger, Michael

    Höchst, 64739

  • Müller, Ulrich. A.

    Jena, 07740

  • Niemetz, Ingo

    Kassel, 34117

  • Schmitz, Ulrike

    Krefeld, 47805

  • Kourbanova, Zarema

    Langenfeld, 40764

  • Willms, Gerhard

    Leverkusen, 51373

  • Ley, Heinz-Georg

    Marl, 45770

  • Grossmann, J.

    Mönchengladbach, 41061

  • Füchtenbusch, Martin

    München, 80804

  • Fueting, Frank

    Nassau, 56377

  • Behnke, Thomas

    Neuwied, 56564

  • Böhme, Rainer

    Nordhausen, 99734

  • Fels, Stefan

    Oldenburg, 28131

  • Klein, Frank

    Schenklengsfeld, 36277

  • Naumann, Rainer

    Schöppenstedt, 38170

  • Rieth-Kunert, Anna

    Stade, 21684

  • Nowack, Kirsten

    Torgau, 04860

  • Schmidt-Reinwald, Astrid

    Waldrach, 54320

  • Bödecker, A.-W.

    Wiehl, 51674

  • Oerter, Erika-Maria

    Würzburg, 97084

Other trials in Germany

About this study

Official title: The Benefit of the Blood Glucose Self Monitoring and a Regular Three-monthly Hemoglobin A1c Profile in Patients With Type 2-diabetes and Conventional Insulin Therapy

The purpose of this randomized, prospective trial is to determine wether (a) a once weekly glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated haemoglobin are effective interventions to improve HbA1c after one year in typ 2-diabetic patients on conventional insulin treatment.

Read the detailed description

The design is an open, prospective, randomised, multicentre parallel group study. The total duration will be 5 years with patient recruitment over 4 years and an individual observation period of 1 year. 300 participants from 43 study centres, hospitals and private practices were recruited. The study will run for one year and aims to determine, whether there is an advantage with regard to HbA1c levels when (a) a regular three-monthly HbA1c or (b) a weekly 4-point glucose profile is taken and reported.

After screening, patients will be assigned at random to one of the following study arms:

  1. no regular blood-glucose self-monitoring, no regular HbA1c
  2. regular blood glucose self monitoring, no regular HbA1c
  3. no regular blood glucose self monitoring, regular HbA1c
  4. regular blood glucose self monitoring, regular HbA1c

The control for all participants is that urinary glucose should be monitored at least once a day, preferably in the late morning, as the highest increase in plasma glucose level occurs after breakfast.

Conditions
Type 2 Diabetes
Being tested
weekly blood glucose profile, three-monthly haemoglobin A1c, no blood-glucose self-control
Keywords
Diabetes control, glycated haemoglobin, blood-glucose-self-monitoring, type 2-diabetes, conventional insulin therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • weekly blood glucose profileProcedure or surgery

    once daily self-control of urinary-glucose

  • three-monthly haemoglobin A1cProcedure or surgery

    once daily self-control of urinary-glucose

  • no blood-glucose self-controlProcedure or surgery

    once daily self-control of urinary-glucose

Study groups in NCT00688363
Study groupRoleWhat they receive
1ExperimentalNo blood-glucose self-control, no HbA1c
Receives: Procedure: no blood-glucose self-control
2ExperimentalBlood-glucose self-control, no HbA1c
Receives: Procedure: weekly blood glucose profile
3ExperimentalNo blood-glucose self-control, HbA1c
Receives: Procedure: three-monthly haemoglobin A1c; Procedure: no blood-glucose self-control
4ExperimentalBlood-glucose self-control, HbA1c
Receives: Procedure: weekly blood glucose profile; Procedure: three-monthly haemoglobin A1c

What is being measured

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

  1. Haemoglobin A1c after one year

    Measured: 1 year

Secondary outcomes (7)

  1. a representative blood glucose profile (self monitoring) during the week before the end of the trial

    Measured: 1 year

  2. body weight at the end of the trial

    Measured: 1 year

  3. serum, triglycerides and cholesterol (total HDL as well as LDL-cholesterol) at the end of the trial

    Measured: 1 year

  4. therapy-satisfaction (questionnaire)

    Measured: 1 year

  5. changes of the antidiabetic therapy

    Measured: 1 year

  6. number of hospitalization as a result of hypoglycaemic episodes

    Measured: 1 year

  7. the number of serious hypoglycaemic episodes (hypoglycaemic episodes when the patient needs help from other people)

    Measured: 1 year

Timeline

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

  1. First posted2 Jun 2008 (estimated)
  2. Study startFeb 2003
  3. Primary completionSep 2008
  4. Study completionDec 2008

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
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00688363
Sponsor's protocol ID
KKS 2003-Nauck-01
Status last verified
Jul 2011
First submitted
26 May 2008
Last updated
1 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • Nauck MA, Haastert B, Trautner C, Muller UA, Nauck MA, Heinemann L; Clinical Trials Study Group of the German Association for the Study of Diabetes (Deutsche Diabetes-Gesellschaft). A randomised, controlled trial of self-monitoring of blood glucose in patients with type 2 diabetes receiving conventional insulin treatment. Diabetologia. 2014 May;57(5):868-77. doi: 10.1007/s00125-014-3168-1. Epub 2014 Jan 21.

    PubMed 24445534

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing weekly blood glucose profile and three-monthly haemoglobin A1c in people with Type 2 Diabetes, run by Deutsche Diabetes Gesellschaft at 41 sites in Germany.

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 4 inclusion and 10 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 1 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Germany. 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?

Haemoglobin A1c after one year (time frame: 1 year). 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 NCT00688363, which also lists 1 linked publication.

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 1 Aug 2011.

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