A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674986
• Other study ID #: RD000590
• Secondary ID: RDC-MI&A-01-2007
• Status: Completed
• Phase: N/A
• First received: May 7, 2008
• Last updated: August 19, 2013
• Start date: March 2008
• Est. completion date: February 2010

Study information

• Verified date: August 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• Accu-Chek 360° View Blood Glucose Analysis Tool

• Accu-Chek Aviva Glucose Meter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12	Blood was collected at Baseline and Month 12 and analyzed at a central laboratory for HbA1c. Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline HbA1c, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.	Baseline, Month 12	No
Secondary	Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations	Treatment intensification was assessed at each clinic visit. The physician evaluated the patient and made recommendations of a change in two areas: changes in diabetic medication and/or changes in lifestyle (such as diet, exercise and education.)	12 Months	No
Secondary	Change From Baseline in Depression Severity (PHQ-8)	The Patient Health Questionnaire-8 (PHQ-8) is an eight-item patient questionnaire to measure the severity of depression disorders over the previous 2 weeks. Each item is rated on a 4-point scale of: 0=not at all to 3=nearly every day. The total score for all items range from 0 (best) to 24 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline PHQ-8, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.	Baseline, Month 12	No
Secondary	Change From Baseline in the Diabetes Distress Scale (DDS)	Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.	Baseline, Month 12	No
Secondary	Change From Baseline in the World Health Organization (WHO-5) Well-being Index	Participants used the WHO-5 to rate their well-being (feeling good and cheerful) for the past 2 weeks using a 6-point scale: 0=At no time to 5=All of the time for a total possible score of 0 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline WHO-5, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.	Baseline, Month 12	No
Secondary	Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2)	Participants rated how confident they felt about managing each of 20 diabetes self-care tasks using the CIDS-2 questionnaire. Responses were given on a 5-point scale ranging from 1=not at all confident to 5=completely confident for a total possible score of 20 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline CIDS-2, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.	Baseline, Month 12	No
Secondary	Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day	SMBG data for all participants was collected by the glucose meter and were uploaded directly to a web server. The mean number of SMBG tests/day was calculated for the entire study period.	12 Months	No
Secondary	Glycemic Variability Pre and Post-Prandial Excursions at Each Meal	Glycemic Variability was evaluated in the STG group for each 3-day set that corresponded to the days the subjects completed the tool before each post-baseline clinic visit. Some parameters used to estimate glycemic variability over the 3-day profile included mean and maximum post-prandial glucose excursions (differences between pre- and post-meal blood glucose levels), mean blood glucose and mean amplitude of glycemic excursion.; The calculation used a Linear mixed model with visit, Month 1 value, gender, age and race (White and Non-White) as fixed effects; and site and subject as random effects.	Month 1, Month 12	No