Trial information
Episodic intensive blood glucose monitoring in non-insulin treated type 2 diabetes.
Status: Recruiting
Protocol number: RD000590
Company division: Diagnostic
Official Scientific Title: A clinical study to evaluate the use of episodic, intensive blood glucose monitoring in persons with non-insulin treated type 2 diabetes.
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 anticipiated time on study treatment is 1 year, and the target sample size is 504 individuals.
Study type: Interventional; Randomized; Open Label; Parallel study
Condition: Diabetes Mellitus, Type 2
Intervention type: Diagnostic Test
Intervention name: AccuChek Aviva Meter with use of Accu-Chek 360 view blood glucose analysis system
Primary outcome: Change in AbA1c levels from baseline. Timeframe: 12 months.
Key secondary outcomes: Evaluation of changes in patients' knowledge of diabetes, self-care behaviours, QoL, attitude and satisfaction with their diabetes care; cost effectiveness analysis; evaluation of treatment intensification and time to treatment intensification. Timeframe: Throughout study.
Inclusion criteria:
- adult patients ≥35 years of age;
- type 2 diabetes for ≥1 year;
- A1c ≥7.5% and ≤11.0%;
- 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.
Gender: Males or Females
Age limits: Min: 35 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: April, 2008
Trial registration date: 05/07/2008
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
United States
- Mobile, AL
- Pell City, AL
- Chipley, FL
- Pembroke Pines, FL
- Atlanta, GA
- O'Fallon, IL
- Fishers, IN
- Indianapolis , IN
- Hickory , NC
- Ohio, OH
- Zanesville, OH
- Pottsville, PA
- High Point, SC
- Crossville, TN
- Abingdon, VA
