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Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

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.
 
ClinicalTrials.gov Identifier: NCT00688363
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : August 1, 2011
Sponsor:
Collaborator:
Bayer
Information provided by:
Deutsche Diabetes Gesellschaft

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
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
Study Start Date : February 2003
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: A1C Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
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 )

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
Show Show 41 study locations
Sponsors and Collaborators
Deutsche Diabetes Gesellschaft
Bayer
Investigators
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Principal Investigator: Michael A. Nauck, Prof. Dr. Diabeteszentrum Bad Lauterberg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. M. Nauck, Kommission Klinische Studien der DDG
ClinicalTrials.gov Identifier: NCT00688363    
Other Study ID Numbers: KKS 2003-Nauck-01
First Posted: June 2, 2008    Key Record Dates
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:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs