Diabetes Mellitus
Conditions
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.
Interventions
DEVICEBGStar
DEVICEglucose meter
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels from baseline | baseline to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Variation in body weight from baseline | at 12 months and 24 months |
| Variation in waist circumference from baseline | at 12 months and 24 months |
| Variation in blood pressure from baseline | at 12 months and 24 months |
| Variation in lipid profile from baseline | at 12 months and 24 months |
| Quality of life: SF12 (Health Survey) questionnaire | at 12 months and 24 months |
| Percentage of participants with HbA1c ≤7.0% | at 12 months and 24 months |
| DTSQ (Diabetes Treatment Satisfaction Questionnaire) | at 12 months and 24 months |
| ABIM-14 (American Board of Internal Medicine satisfaction questionnaire) | at 12 months and 24 months |
| PDM (Patient involvement in the Decision Making process) questionnaire | at 12 months and 24 months |
| PHCO (Patient Health Care Orientation) questionnaire | at 12 months and 24 months |
| Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS) | at 12 months and 24 months |
| ADDQOL (Audit of Diabetes-Dependent Quality of Life) | at 12 months and 24 months |
Countries
Italy
Outcome results
None listed