Efficacy of a Chronic Care Model Supported by Self Monitoring of Blood Glucose With BGStar Over Usual Care in Improving Glycemic Control in Patients With Type 2 Diabetes Not Treated With Insulin

Diabetes Mellitus Clinical Trial

— SELF CARE  

Official title:

Randomized Clinical Trial on the Efficacy of Self-Monitoring Blood Glucose in the Context of a Chronic Care Model for Type 2 Diabetes Patients Treated With Oral Agents Only

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082028
• Other study ID #: BGSTA_L_05978
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: May 2, 2017
• Start date: June 27, 2012
• Est. completion date: July 30, 2015

Study information

• Verified date: May 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate the superiority of a chronic care model (SINERGIA model) supported by the Self Monitoring of Blood Glucose with BGStar over usual care in improving glycemic control at 12 months in patients with type 2 diabetes not treated with insulin.

Description:

The planned study duration is 36 months (9 quarters). The estimated duration of screening/enrollment will be 12 months, followed by the 12-month experimental phase, plus the 12-month follow-up in the observational phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: July 30, 2015
• Est. primary completion date: July 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Males and females

• Age = 45 years

• Type 2 diabetes

• First access at the diabetes clinic

• Any diabetes duration

• HbA1c >7.0 and = 9.0%

• Already treated with any oral antidiabetic agent (OAD) or requiring the initiation of therapy with OAD

• Patients not using SMBG or using SMBG with a frequency =1 test/week

• Written informed consent

Exclusion Criteria:

Treatment with insulin or need to start insulin regimens or continuous sub-cutaneous insulin infusion at the first access; Refusal or inability to give informed consent to participate in the study;

Conditions / situations such as:

• Patients with short life expectancy;

• Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment;

• Requirement for concomitant treatment that could bias primary evaluation (i.e. corticosteroid treatment);

• Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study;

• Current addition/abuse of alcohol or drugs;

• Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study;

• Pregnant or breast-feeding women;

• Patients living too far from investigational center or other conditions reducing the adherence to the protocol; Subjects unlikely or unable to comply with the Protocol requirements (e.g. illiterate, uncooperative, unable to return for follow-up visit, unable to use BGStar unlikely to complete the study)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• BGStar

• glucose meter

Locations

Country	Name	City	State
Italy	Investigational Site Number 016	Andria (BA)
Italy	Investigational Site Number 011	Avezzano
Italy	Investigational Site Number 006	Bergamo
Italy	Investigational Site Number 002	Brescia
Italy	Investigational Site Number 022	Catania
Italy	Investigational Site Number 001	Cusano Milanino
Italy	Investigational Site Number 013	Livorno
Italy	Investigational Site Number 015	Lucca
Italy	Investigational Site Number 004	Mariano Comense
Italy	Investigational Site Number 017	Messina
Italy	Investigational Site Number 008	Milano
Italy	Investigational Site Number 018	Napoli
Italy	Investigational Site Number 021	Potenza
Italy	Investigational Site Number 020	Ragusa
Italy	Investigational Site Number 014	Ravenna
Italy	Investigational Site Number 012	Rimini
Italy	Investigational Site Number 009	Roma
Italy	Investigational Site Number 019	Terlizzi (BA)
Italy	Investigational Site Number 007	Torino
Italy	Investigational Site Number 003	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c levels from baseline		baseline to 12 months
Secondary	Percentage of participants with HbA1c =7.0%		at 12 months and 24 months
Secondary	Variation in body weight from baseline		at 12 months and 24 months
Secondary	Variation in waist circumference from baseline		at 12 months and 24 months
Secondary	Variation in blood pressure from baseline		at 12 months and 24 months
Secondary	Variation in lipid profile from baseline		at 12 months and 24 months
Secondary	Quality of life: SF12 (Health Survey) questionnaire		at 12 months and 24 months
Secondary	ADDQOL (Audit of Diabetes-Dependent Quality of Life)		at 12 months and 24 months
Secondary	DTSQ (Diabetes Treatment Satisfaction Questionnaire)		at 12 months and 24 months
Secondary	ABIM-14 (American Board of Internal Medicine satisfaction questionnaire)		at 12 months and 24 months
Secondary	PDM (Patient involvement in the Decision Making process) questionnaire		at 12 months and 24 months
Secondary	PHCO (Patient Health Care Orientation) questionnaire		at 12 months and 24 months
Secondary	Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)		at 12 months and 24 months