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Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688363
First Posted: June 2, 2008
Last Update Posted: August 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by:
Deutsche Diabetes Gesellschaft
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Procedure: weekly blood glucose profile Procedure: three-monthly haemoglobin A1c Procedure: no blood-glucose self-control Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Deutsche Diabetes Gesellschaft:

Primary Outcome Measures:
  • Haemoglobin A1c after one year [ Time Frame: 1 year ]

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

Enrollment: 300
Study Start Date: February 2003
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: three-monthly haemoglobin A1c
once daily self-control of urinary-glucose
Procedure: no blood-glucose self-control
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 )
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688363


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. M. Nauck, Kommission Klinische Studien der DDG
ClinicalTrials.gov Identifier: NCT00688363     History of Changes
Other Study ID Numbers: KKS 2003-Nauck-01
First Submitted: May 26, 2008
First Posted: June 2, 2008
Last Update Posted: August 1, 2011
Last Verified: July 2011

Keywords provided by Deutsche Diabetes Gesellschaft:
Diabetes control
glycated haemoglobin
blood-glucose-self-monitoring
type 2-diabetes
conventional insulin therapy

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases