Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688363
• Other study ID #: KKS 2003-Nauck-01
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2008
• Last updated: July 29, 2011
• Start date: February 2003
• Est. completion date: December 2008

Study information

• Verified date: July 2011
• Source: Deutsche Diabetes Gesellschaft
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Procedure:
• weekly blood glucose profile
once daily self-control of urinary-glucose
• three-monthly haemoglobin A1c
once daily self-control of urinary-glucose
• no blood-glucose self-control
once daily self-control of urinary-glucose

Locations

Country	Name	City	State
Germany	Koch, Peter	Bad Harzburg
Germany	Maxeiner, Stefan	Bad Kreuznach
Germany	Diabeteszentrum Bad Lauterberg	Bad Lauterberg	Niedersachsen
Germany	Friedrichs, Michael	Bad Lauterberg
Germany	Jödicke, Carmen	Bad Lauterberg
Germany	Mulch-Wiemer, Christa	Bad Nauheim
Germany	Bellmann, Renate	Berlin
Germany	Schoch, Daniela	Berlin
Germany	Warmers, Ulrike	Bitburg
Germany	Leupold, Manfred	Borna
Germany	Kamke, Wolfram	Burg/Sreewald
Germany	Hildebrandt, Rüdiger	Clausthal-Zellerfeld
Germany	Lemmerhirt, Jürgen	Cuxhaven
Germany	Preuß, Uwe	Datteln
Germany	Weller, Ulrich	Dorsten
Germany	Fischer, Harald	Düren
Germany	Krege, Peter	Emsdetten
Germany	Gölz, Stefan	Esslingen
Germany	Wollersen, Karin	Freiburg
Germany	Hendel, Andreas	Grassau
Germany	Pfeiffer, Martha	Gronau
Germany	Jäger, Michael	Höchst
Germany	Müller, Ulrich. A.	Jena
Germany	Niemetz, Ingo	Kassel
Germany	Schmitz, Ulrike	Krefeld
Germany	Kourbanova, Zarema	Langenfeld
Germany	Willms, Gerhard	Leverkusen
Germany	Ley, Heinz-Georg	Marl
Germany	Grossmann, J.	Mönchengladbach
Germany	Füchtenbusch, Martin	München
Germany	Fueting, Frank	Nassau
Germany	Behnke, Thomas	Neuwied
Germany	Böhme, Rainer	Nordhausen
Germany	Fels, Stefan	Oldenburg
Germany	Klein, Frank	Schenklengsfeld
Germany	Naumann, Rainer	Schöppenstedt
Germany	Rieth-Kunert, Anna	Stade
Germany	Nowack, Kirsten	Torgau
Germany	Schmidt-Reinwald, Astrid	Waldrach
Germany	Bödecker, A.-W.	Wiehl
Germany	Oerter, Erika-Maria	Würzburg

Sponsors (2)

Lead Sponsor	Collaborator
Deutsche Diabetes Gesellschaft	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin A1c after one year		1 year	No
Secondary	a representative blood glucose profile (self monitoring) during the week before the end of the trial		1 year	No
Secondary	body weight at the end of the trial		1 year	No
Secondary	serum, triglycerides and cholesterol (total HDL as well as LDL-cholesterol) at the end of the trial		1 year	No
Secondary	therapy-satisfaction (questionnaire)		1 year	No
Secondary	changes of the antidiabetic therapy		1 year	No
Secondary	number of hospitalization as a result of hypoglycaemic episodes		1 year	No
Secondary	the number of serious hypoglycaemic episodes (hypoglycaemic episodes when the patient needs help from other people)		1 year	No