Clinical trial NCT02082028: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-03-07
Enrollment: 241
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in HbA1c levels from baseline
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Percentage of participants with HbA1c ≤7.0%
timeFrame: at 12 months and 24 months
measure: Variation in body weight from baseline
timeFrame: at 12 months and 24 months
measure: Variation in waist circumference from baseline
timeFrame: at 12 months and 24 months
measure: Variation in blood pressure from baseline
timeFrame: at 12 months and 24 months
measure: Variation in lipid profile from baseline
timeFrame: at 12 months and 24 months
measure: Quality of life: SF12 (Health Survey) questionnaire
timeFrame: at 12 months and 24 months
measure: ADDQOL (Audit of Diabetes-Dependent Quality of Life)
timeFrame: at 12 months and 24 months
measure: DTSQ (Diabetes Treatment Satisfaction Questionnaire)
timeFrame: at 12 months and 24 months
measure: ABIM-14 (American Board of Internal Medicine satisfaction questionnaire)
timeFrame: at 12 months and 24 months
measure: PDM (Patient involvement in the Decision Making process) questionnaire
timeFrame: at 12 months and 24 months
measure: PHCO (Patient Health Care Orientation) questionnaire
timeFrame: at 12 months and 24 months
measure: Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)
timeFrame: at 12 months and 24 months
Other outcomes:
Locations:
city: Andria (BA)
country: Italy
facility: Investigational Site Number 016
city: Avezzano
country: Italy
facility: Investigational Site Number 011
city: Bergamo
country: Italy
facility: Investigational Site Number 006
city: Brescia
country: Italy
facility: Investigational Site Number 002
city: Catania
country: Italy
facility: Investigational Site Number 022
city: Cusano Milanino
country: Italy
facility: Investigational Site Number 001
city: Livorno
country: Italy
facility: Investigational Site Number 013
city: Lucca
country: Italy
facility: Investigational Site Number 015
city: Mariano Comense
country: Italy
facility: Investigational Site Number 004
city: Messina
country: Italy
facility: Investigational Site Number 017
city: Milano
country: Italy
facility: Investigational Site Number 008
city: Napoli
country: Italy
facility: Investigational Site Number 018
city: Potenza
country: Italy
facility: Investigational Site Number 021
city: Ragusa
country: Italy
facility: Investigational Site Number 020
city: Ravenna
country: Italy
facility: Investigational Site Number 014
city: Rimini
country: Italy
facility: Investigational Site Number 012
city: Roma
country: Italy
facility: Investigational Site Number 009
city: Terlizzi (BA)
country: Italy
facility: Investigational Site Number 019
city: Torino
country: Italy
facility: Investigational Site Number 007
city: Udine
country: Italy
facility: Investigational Site Number 003
Study officials:
affiliation: Sanofi
name: Clinical Science & Operations
role: STUDY_DIRECTOR
References: