Clinical trial NCT00674986: A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes
Official title: A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-05-08
Enrollment: 522
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This randomized, parallel group study will determine whether the use of episodic, intensive glucose monitoring via the Accu-Chek 360 view blood glucose analysis system has a positive effect on overall glycemic control. Patients will be randomized into either the 'usual care' group, or the 'interventional group' supplemented with the Accu-Chek 360 view blood glucose analysis system. The effect of each treatment regimen on glycemic control will be assessed by measurement of change in baseline HbA1c values at 12 months. The anticipated time on study treatment is 1 year, and the target sample size is 504 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult patients \>= 25 years of age
* Type 2 diabetes for \>= 1 year
* Hemoglobin A1c \>= 7.5% and \<=11%
* Diabetes managed by exercise and diet, prescription oral medication or an injectable incretin mimetic

Exclusion Criteria:

* Type 1 diabetes
* On any type of insulin therapy at start of study

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations
timeFrame: 12 Months
measure: Change From Baseline in Depression Severity (PHQ-8)
timeFrame: Baseline, Month 12
measure: Change From Baseline in the Diabetes Distress Scale (DDS)
timeFrame: Baseline, Month 12
measure: Change From Baseline in the World Health Organization (WHO-5) Well-being Index
timeFrame: Baseline, Month 12
measure: Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2)
timeFrame: Baseline, Month 12
measure: Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day
timeFrame: 12 Months
measure: Glycemic Variability Pre and Post-Prandial Excursions at Each Meal
timeFrame: Month 1, Month 12
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Pell City
country: United States
state: Alabama
city: Chipley
country: United States
state: Florida
city: Marianna
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: O'fallon
country: United States
state: Illinois
city: Fishers
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Flint
country: United States
state: Michigan
city: Hickory
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cuyahoga Falls
country: United States
state: Ohio
city: Zanesville
country: United States
state: Ohio
city: Pottstown
country: United States
state: Pennsylvania
city: Pottstown
country: United States
state: Pennsylvania
city: High Point
country: United States
state: South Carolina
city: Lancaster
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Crossville
country: United States
state: Tennessee
city: Abingdon
country: United States
state: Virginia
Study officials:
affiliation: Roche Diagnostics GmbH
name: Bettina Petersen
role: STUDY_DIRECTOR
References:
citation: Fisher L, Polonsky W, Parkin CG, Jelsovsky Z, Amstutz L, Wagner RS. The impact of blood glucose monitoring on depression and distress in insulin-naive patients with type 2 diabetes. Curr Med Res Opin. 2011 Nov;27 Suppl 3:39-46. doi: 10.1185/03007995.2011.619176. Epub 2011 Sep 14.
citation: Polonsky WH, Fisher L, Schikman CH, Hinnen DA, Parkin CG, Jelsovsky Z, Petersen B, Schweitzer M, Wagner RS. Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. Diabetes Care. 2011 Feb;34(2):262-7. doi: 10.2337/dc10-1732.
citation: Polonsky W, Fisher L, Schikman C, Hinnen D, Parkin C, Jelsovsky Z, Amstutz L, Schweitzer M, Wagner R. The value of episodic, intensive blood glucose monitoring in non-insulin treated persons with Type 2 Diabetes: design of the Structured Testing Program (STeP) study, a cluster-randomised, clinical trial [NCT00674986]. BMC Fam Pract. 2010 May 18;11:37. doi: 10.1186/1471-2296-11-37.