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Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
weekly blood glucose profile
three-monthly haemoglobin A1c
no blood-glucose self-control
Sponsored by
Deutsche Diabetes Gesellschaft
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 2 Diabetes focused on measuring Diabetes control, glycated haemoglobin, blood-glucose-self-monitoring, type 2-diabetes, conventional insulin therapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 )

Sites / Locations

  • Diabeteszentrum Bad Lauterberg
  • Koch, Peter
  • Maxeiner, Stefan
  • Friedrichs, Michael
  • Jödicke, Carmen
  • Mulch-Wiemer, Christa
  • Bellmann, Renate
  • Schoch, Daniela
  • Warmers, Ulrike
  • Leupold, Manfred
  • Kamke, Wolfram
  • Hildebrandt, Rüdiger
  • Lemmerhirt, Jürgen
  • Preuß, Uwe
  • Weller, Ulrich
  • Fischer, Harald
  • Krege, Peter
  • Gölz, Stefan
  • Wollersen, Karin
  • Hendel, Andreas
  • Pfeiffer, Martha
  • Jäger, Michael
  • Müller, Ulrich. A.
  • Niemetz, Ingo
  • Schmitz, Ulrike
  • Kourbanova, Zarema
  • Willms, Gerhard
  • Ley, Heinz-Georg
  • Grossmann, J.
  • Füchtenbusch, Martin
  • Fueting, Frank
  • Behnke, Thomas
  • Böhme, Rainer
  • Fels, Stefan
  • Klein, Frank
  • Naumann, Rainer
  • Rieth-Kunert, Anna
  • Nowack, Kirsten
  • Schmidt-Reinwald, Astrid
  • Bödecker, A.-W.
  • Oerter, Erika-Maria

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

No blood-glucose self-control, no HbA1c

Blood-glucose self-control, no HbA1c

No blood-glucose self-control, HbA1c

Blood-glucose self-control, HbA1c

Outcomes

Primary Outcome Measures

Haemoglobin A1c after one year

Secondary Outcome Measures

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

Full Information

First Posted
May 26, 2008
Last Updated
July 29, 2011
Sponsor
Deutsche Diabetes Gesellschaft
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00688363
Brief Title
Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Deutsche Diabetes Gesellschaft
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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: no regular blood-glucose self-monitoring, no regular HbA1c regular blood glucose self monitoring, no regular HbA1c no regular blood glucose self monitoring, regular HbA1c 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes control, glycated haemoglobin, blood-glucose-self-monitoring, type 2-diabetes, conventional insulin therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
No blood-glucose self-control, no HbA1c
Arm Title
2
Arm Type
Experimental
Arm Description
Blood-glucose self-control, no HbA1c
Arm Title
3
Arm Type
Experimental
Arm Description
No blood-glucose self-control, HbA1c
Arm Title
4
Arm Type
Experimental
Arm Description
Blood-glucose self-control, HbA1c
Intervention Type
Procedure
Intervention Name(s)
weekly blood glucose profile
Intervention Description
once daily self-control of urinary-glucose
Intervention Type
Procedure
Intervention Name(s)
three-monthly haemoglobin A1c
Intervention Description
once daily self-control of urinary-glucose
Intervention Type
Procedure
Intervention Name(s)
no blood-glucose self-control
Intervention Description
once daily self-control of urinary-glucose
Primary Outcome Measure Information:
Title
Haemoglobin A1c after one year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
a representative blood glucose profile (self monitoring) during the week before the end of the trial
Time Frame
1 year
Title
body weight at the end of the trial
Time Frame
1 year
Title
serum, triglycerides and cholesterol (total HDL as well as LDL-cholesterol) at the end of the trial
Time Frame
1 year
Title
therapy-satisfaction (questionnaire)
Time Frame
1 year
Title
changes of the antidiabetic therapy
Time Frame
1 year
Title
number of hospitalization as a result of hypoglycaemic episodes
Time Frame
1 year
Title
the number of serious hypoglycaemic episodes (hypoglycaemic episodes when the patient needs help from other people)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Nauck, Prof. Dr.
Organizational Affiliation
Diabeteszentrum Bad Lauterberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabeteszentrum Bad Lauterberg
City
Bad Lauterberg
State/Province
Niedersachsen
ZIP/Postal Code
D-37431
Country
Germany
Facility Name
Koch, Peter
City
Bad Harzburg
ZIP/Postal Code
38667
Country
Germany
Facility Name
Maxeiner, Stefan
City
Bad Kreuznach
ZIP/Postal Code
55545
Country
Germany
Facility Name
Friedrichs, Michael
City
Bad Lauterberg
ZIP/Postal Code
37431
Country
Germany
Facility Name
Jödicke, Carmen
City
Bad Lauterberg
ZIP/Postal Code
37431
Country
Germany
Facility Name
Mulch-Wiemer, Christa
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Bellmann, Renate
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
Schoch, Daniela
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
Warmers, Ulrike
City
Bitburg
ZIP/Postal Code
54634
Country
Germany
Facility Name
Leupold, Manfred
City
Borna
ZIP/Postal Code
04552
Country
Germany
Facility Name
Kamke, Wolfram
City
Burg/Sreewald
ZIP/Postal Code
03096
Country
Germany
Facility Name
Hildebrandt, Rüdiger
City
Clausthal-Zellerfeld
ZIP/Postal Code
38678
Country
Germany
Facility Name
Lemmerhirt, Jürgen
City
Cuxhaven
ZIP/Postal Code
27474
Country
Germany
Facility Name
Preuß, Uwe
City
Datteln
ZIP/Postal Code
45711
Country
Germany
Facility Name
Weller, Ulrich
City
Dorsten
ZIP/Postal Code
46282
Country
Germany
Facility Name
Fischer, Harald
City
Düren
ZIP/Postal Code
52351
Country
Germany
Facility Name
Krege, Peter
City
Emsdetten
ZIP/Postal Code
48282
Country
Germany
Facility Name
Gölz, Stefan
City
Esslingen
ZIP/Postal Code
73728
Country
Germany
Facility Name
Wollersen, Karin
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Hendel, Andreas
City
Grassau
ZIP/Postal Code
83224
Country
Germany
Facility Name
Pfeiffer, Martha
City
Gronau
ZIP/Postal Code
48559
Country
Germany
Facility Name
Jäger, Michael
City
Höchst
ZIP/Postal Code
64739
Country
Germany
Facility Name
Müller, Ulrich. A.
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Niemetz, Ingo
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
Schmitz, Ulrike
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Facility Name
Kourbanova, Zarema
City
Langenfeld
ZIP/Postal Code
40764
Country
Germany
Facility Name
Willms, Gerhard
City
Leverkusen
ZIP/Postal Code
51373
Country
Germany
Facility Name
Ley, Heinz-Georg
City
Marl
ZIP/Postal Code
45770
Country
Germany
Facility Name
Grossmann, J.
City
Mönchengladbach
ZIP/Postal Code
41061
Country
Germany
Facility Name
Füchtenbusch, Martin
City
München
ZIP/Postal Code
80804
Country
Germany
Facility Name
Fueting, Frank
City
Nassau
ZIP/Postal Code
56377
Country
Germany
Facility Name
Behnke, Thomas
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Böhme, Rainer
City
Nordhausen
ZIP/Postal Code
99734
Country
Germany
Facility Name
Fels, Stefan
City
Oldenburg
ZIP/Postal Code
28131
Country
Germany
Facility Name
Klein, Frank
City
Schenklengsfeld
ZIP/Postal Code
36277
Country
Germany
Facility Name
Naumann, Rainer
City
Schöppenstedt
ZIP/Postal Code
38170
Country
Germany
Facility Name
Rieth-Kunert, Anna
City
Stade
ZIP/Postal Code
21684
Country
Germany
Facility Name
Nowack, Kirsten
City
Torgau
ZIP/Postal Code
04860
Country
Germany
Facility Name
Schmidt-Reinwald, Astrid
City
Waldrach
ZIP/Postal Code
54320
Country
Germany
Facility Name
Bödecker, A.-W.
City
Wiehl
ZIP/Postal Code
51674
Country
Germany
Facility Name
Oerter, Erika-Maria
City
Würzburg
ZIP/Postal Code
97084
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24445534
Citation
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.
Results Reference
derived

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Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

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