title: Use of a Combined Blood-Glucose- and ß-Ketone-Measuring Device Improves Glycemic Control in Insulin-Treated Patients With Diabetes: The Gold Plus Study.
abstract: BACKGROUND
  Using self-measurements of blood glucose (SMBG) is daily routine for patients with insulin-treated diabetes, however measuring ß-ketones in blood is not widespread. How the use of a combined device, which can measure both, is accepted in daily routine by patients and will lead to better glycemic control is not well studied.
  
  
  METHODS
  This multicenter, prospective, noninterventional study assessed the impact of routine use of the GlucoMen® LX Plus on patient acceptance, usage and glycemic control among insulin-treated patients with diabetes mellitus type 1 and type 2. A1c and self-reported frequency of SMBG were evaluated at baseline and also postprandial SMBG, ß-ketone measurements, and use of reminders after 3 and 6 months of use. A total of 631 patients, 254 type 1/350 type 2 (27 no type specified), with mean (SD) baseline A1c 8.5% (1.5), age 54.6 (15.6) years, and 47.3% female were studied.
  
  
  RESULTS
  Frequent use of SMBG at baseline led to a higher decrease in A1c at 6 month (V3): -0.3% if SMBG measured up to 1/day versus -0.9% in 4-6/day. Increase of SMBG frequency during the study showed also a negative correlation to A1c, 9.2% at V1 versus 7.6% at V3. Postprandial SMBG was done by 77.7% and ß-ketone measurements by 45.5% of all patients; the reminders were used by 33.4% and led to an increased frequency of SMBG at 6 months.
  
  
  CONCLUSIONS
  A combined device for SMBG and ß-ketone measurements is well accepted by patients with insulin-treated diabetes and can lead through the avoidance or detection of ketoacidosis/increased frequency of SMBG and increased awareness of the patients to an improved glycemic outcome.
authors.affiliation: Diabetes Clinic for Children and Adolescents, Muenster, Germany rz@ziegler-muenster.de.
authors.forename: Ralph
authors.initials: R
authors.lastname: Ziegler
authors.affiliation: GKM Gesellschaft für Therapieforschung mbH, Munich, Germany.
authors.forename: Rudolf
authors.initials: R
authors.lastname: Eichholz
authors.affiliation: A. Menarini Diagnostics, Division of Berlin-Chemie AG, Berlin, Germany.
authors.forename: Birgit
authors.initials: B
authors.lastname: Schulz
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy; D004867:Equipment Design; D005260:Female; D005858:Germany; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000627:therapeutic use; D007659:Ketones / Q000097:blood*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011237:Predictive Value of Tests; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D007659:Ketones; C517652:hemoglobin A1c protein, human
keywords: blood glucose meter; blood ketone meter; self-monitoring of blood glucose; self-monitoring of blood ketones