Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Deutsche Diabetes Gesellschaft
ClinicalTrials.gov Identifier:
NCT00688363
First received: May 26, 2008
Last updated: July 29, 2011
Last verified: July 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • a representative blood glucose profile (self monitoring) during the week before the end of the trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • body weight at the end of the trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • serum, triglycerides and cholesterol (total HDL as well as LDL-cholesterol) at the end of the trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • therapy-satisfaction (questionnaire) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • changes of the antidiabetic therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • number of hospitalization as a result of hypoglycaemic episodes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • the number of serious hypoglycaemic episodes (hypoglycaemic episodes when the patient needs help from other people) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688363

Locations
Germany
Diabeteszentrum Bad Lauterberg
Bad Lauterberg, Niedersachsen, Germany, D-37431
Koch, Peter
Bad Harzburg, Germany, 38667
Maxeiner, Stefan
Bad Kreuznach, Germany, 55545
Jödicke, Carmen
Bad Lauterberg, Germany, 37431
Friedrichs, Michael
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

No publications provided by Deutsche Diabetes Gesellschaft

Additional 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
Study First Received: May 26, 2008
Last Updated: July 29, 2011
Health Authority: Germany: Ethics Commission

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
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014