Clinical trial NCT00688363: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Diabetes control
glycated haemoglobin
blood-glucose-self-monitoring
type 2-diabetes
conventional insulin therapy
Lead sponsor: Deutsche Diabetes Gesellschaft
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2008-06-02
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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:

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 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 )

Primary outcomes:
measure: Haemoglobin A1c after one year
timeFrame: 1 year
Secondary outcomes:
measure: a representative blood glucose profile (self monitoring) during the week before the end of the trial
timeFrame: 1 year
measure: body weight at the end of the trial
timeFrame: 1 year
measure: serum, triglycerides and cholesterol (total HDL as well as LDL-cholesterol) at the end of the trial
timeFrame: 1 year
measure: therapy-satisfaction (questionnaire)
timeFrame: 1 year
measure: changes of the antidiabetic therapy
timeFrame: 1 year
measure: number of hospitalization as a result of hypoglycaemic episodes
timeFrame: 1 year
measure: the number of serious hypoglycaemic episodes (hypoglycaemic episodes when the patient needs help from other people)
timeFrame: 1 year
Other outcomes:
Locations:
city: Bad Lauterberg
country: Germany
facility: Diabeteszentrum Bad Lauterberg
state: Niedersachsen
city: Bad Harzburg
country: Germany
facility: Koch, Peter
city: Bad Kreuznach
country: Germany
facility: Maxeiner, Stefan
city: Bad Lauterberg
country: Germany
facility: Friedrichs, Michael
city: Bad Lauterberg
country: Germany
facility: Jödicke, Carmen
city: Bad Nauheim
country: Germany
facility: Mulch-Wiemer, Christa
city: Berlin
country: Germany
facility: Bellmann, Renate
city: Berlin
country: Germany
facility: Schoch, Daniela
city: Bitburg
country: Germany
facility: Warmers, Ulrike
city: Borna
country: Germany
facility: Leupold, Manfred
city: Burg/Sreewald
country: Germany
facility: Kamke, Wolfram
city: Clausthal-Zellerfeld
country: Germany
facility: Hildebrandt, Rüdiger
city: Cuxhaven
country: Germany
facility: Lemmerhirt, Jürgen
city: Datteln
country: Germany
facility: Preuß, Uwe
city: Dorsten
country: Germany
facility: Weller, Ulrich
city: Düren
country: Germany
facility: Fischer, Harald
city: Emsdetten
country: Germany
facility: Krege, Peter
city: Esslingen
country: Germany
facility: Gölz, Stefan
city: Freiburg
country: Germany
facility: Wollersen, Karin
city: Grassau
country: Germany
facility: Hendel, Andreas
city: Gronau
country: Germany
facility: Pfeiffer, Martha
city: Höchst
country: Germany
facility: Jäger, Michael
city: Jena
country: Germany
facility: Müller, Ulrich. A.
city: Kassel
country: Germany
facility: Niemetz, Ingo
city: Krefeld
country: Germany
facility: Schmitz, Ulrike
city: Langenfeld
country: Germany
facility: Kourbanova, Zarema
city: Leverkusen
country: Germany
facility: Willms, Gerhard
city: Marl
country: Germany
facility: Ley, Heinz-Georg
city: Mönchengladbach
country: Germany
facility: Grossmann, J.
city: München
country: Germany
facility: Füchtenbusch, Martin
city: Nassau
country: Germany
facility: Fueting, Frank
city: Neuwied
country: Germany
facility: Behnke, Thomas
city: Nordhausen
country: Germany
facility: Böhme, Rainer
city: Oldenburg
country: Germany
facility: Fels, Stefan
city: Schenklengsfeld
country: Germany
facility: Klein, Frank
city: Schöppenstedt
country: Germany
facility: Naumann, Rainer
city: Stade
country: Germany
facility: Rieth-Kunert, Anna
city: Torgau
country: Germany
facility: Nowack, Kirsten
city: Waldrach
country: Germany
facility: Schmidt-Reinwald, Astrid
city: Wiehl
country: Germany
facility: Bödecker, A.-W.
city: Würzburg
country: Germany
facility: Oerter, Erika-Maria
Study officials:
affiliation: Diabeteszentrum Bad Lauterberg
name: Michael A. Nauck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.