Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

July 29, 2011 updated by: Deutsche Diabetes Gesellschaft

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Harzburg, Germany, 38667
        • Koch, Peter
      • Bad Kreuznach, Germany, 55545
        • Maxeiner, Stefan
      • Bad Lauterberg, Germany, 37431
        • Friedrichs, Michael
      • Bad Lauterberg, Germany, 37431
        • Jödicke, Carmen
      • Bad Nauheim, Germany, 61231
        • Mulch-Wiemer, Christa
      • Berlin, Germany, 10365
        • Bellmann, Renate
      • Berlin, Germany, 13055
        • Schoch, Daniela
      • Bitburg, Germany, 54634
        • Warmers, Ulrike
      • Borna, Germany, 04552
        • Leupold, Manfred
      • Burg/Sreewald, Germany, 03096
        • Kamke, Wolfram
      • Clausthal-Zellerfeld, Germany, 38678
        • Hildebrandt, Rüdiger
      • Cuxhaven, Germany, 27474
        • Lemmerhirt, Jürgen
      • Datteln, Germany, 45711
        • Preuß, Uwe
      • Dorsten, Germany, 46282
        • Weller, Ulrich
      • Düren, Germany, 52351
        • Fischer, Harald
      • Emsdetten, Germany, 48282
        • Krege, Peter
      • Esslingen, Germany, 73728
        • Gölz, Stefan
      • Freiburg, Germany, 79106
        • Wollersen, Karin
      • Grassau, Germany, 83224
        • Hendel, Andreas
      • Gronau, Germany, 48559
        • Pfeiffer, Martha
      • Höchst, Germany, 64739
        • Jäger, Michael
      • Jena, Germany, 07740
        • Müller, Ulrich. A.
      • Kassel, Germany, 34117
        • Niemetz, Ingo
      • Krefeld, Germany, 47805
        • Schmitz, Ulrike
      • Langenfeld, Germany, 40764
        • Kourbanova, Zarema
      • Leverkusen, Germany, 51373
        • Willms, Gerhard
      • Marl, Germany, 45770
        • Ley, Heinz-Georg
      • Mönchengladbach, Germany, 41061
        • Grossmann, J.
      • München, Germany, 80804
        • Füchtenbusch, Martin
      • Nassau, Germany, 56377
        • Fueting, Frank
      • Neuwied, Germany, 56564
        • Behnke, Thomas
      • Nordhausen, Germany, 99734
        • Böhme, Rainer
      • Oldenburg, Germany, 28131
        • Fels, Stefan
      • Schenklengsfeld, Germany, 36277
        • Klein, Frank
      • Schöppenstedt, Germany, 38170
        • Naumann, Rainer
      • Stade, Germany, 21684
        • Rieth-Kunert, Anna
      • Torgau, Germany, 04860
        • Nowack, Kirsten
      • Waldrach, Germany, 54320
        • Schmidt-Reinwald, Astrid
      • Wiehl, Germany, 51674
        • Bödecker, A.-W.
      • Würzburg, Germany, 97084
        • Oerter, Erika-Maria
    • Niedersachsen
      • Bad Lauterberg, Niedersachsen, Germany, D-37431
        • Diabeteszentrum Bad Lauterberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
No blood-glucose self-control, no HbA1c
Procedure: no blood-glucose self-control
once daily self-control of urinary-glucose
Experimental: 2
Blood-glucose self-control, no HbA1c
Procedure: weekly blood glucose profile
once daily self-control of urinary-glucose
Experimental: 3
No blood-glucose self-control, HbA1c
Procedure: no blood-glucose self-control
once daily self-control of urinary-glucose
Procedure: three-monthly haemoglobin A1c
once daily self-control of urinary-glucose
Experimental: 4
Blood-glucose self-control, HbA1c
Procedure: weekly blood glucose profile
once daily self-control of urinary-glucose
Procedure: three-monthly haemoglobin A1c
once daily self-control of urinary-glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Haemoglobin A1c after one year
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
a representative blood glucose profile (self monitoring) during the week before the end of the trial
Time Frame: 1 year
1 year
body weight at the end of the trial
Time Frame: 1 year
1 year
serum, triglycerides and cholesterol (total HDL as well as LDL-cholesterol) at the end of the trial
Time Frame: 1 year
1 year
therapy-satisfaction (questionnaire)
Time Frame: 1 year
1 year
changes of the antidiabetic therapy
Time Frame: 1 year
1 year
number of hospitalization as a result of hypoglycaemic episodes
Time Frame: 1 year
1 year
the number of serious hypoglycaemic episodes (hypoglycaemic episodes when the patient needs help from other people)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsche Diabetes Gesellschaft

Collaborators

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 26, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (Estimate)

June 2, 2008

Study Record Updates

Last Update Posted (Estimate)

August 1, 2011

Last Update Submitted That Met QC Criteria

July 29, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKS 2003-Nauck-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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