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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 (SELF CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02082028
Recruitment Status : Completed
First Posted : March 7, 2014
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: BGStar Device: glucose meter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 27, 2012
Actual Primary Completion Date : July 30, 2015
Actual Study Completion Date : July 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: A (BGStar)
Patients will be educated within the context of the SINERGIA educational program to understand how to manage their own diabetes on the basis of their Self Monitoring of Blood Glucose values obtained with BGStar. Patients will be requested two 6-points profiles monthly.
Device: BGStar
Active Comparator: B (traditional approach)
Usual approach for the disease management. Patients in Group B will receive usual education and, at any time during the study duration, if needed, will be instructed on Self Monitoring of Blood Glucose, performed with any glucose meter.
Device: glucose meter

Primary Outcome Measures :
  1. Change in HbA1c levels from baseline [ Time Frame: baseline to 12 months ]

Secondary Outcome Measures :
  1. Percentage of participants with HbA1c ≤7.0% [ Time Frame: at 12 months and 24 months ]
  2. Variation in body weight from baseline [ Time Frame: at 12 months and 24 months ]
  3. Variation in waist circumference from baseline [ Time Frame: at 12 months and 24 months ]
  4. Variation in blood pressure from baseline [ Time Frame: at 12 months and 24 months ]
  5. Variation in lipid profile from baseline [ Time Frame: at 12 months and 24 months ]
  6. Quality of life: SF12 (Health Survey) questionnaire [ Time Frame: at 12 months and 24 months ]
  7. ADDQOL (Audit of Diabetes-Dependent Quality of Life) [ Time Frame: at 12 months and 24 months ]
  8. DTSQ (Diabetes Treatment Satisfaction Questionnaire) [ Time Frame: at 12 months and 24 months ]
  9. ABIM-14 (American Board of Internal Medicine satisfaction questionnaire) [ Time Frame: at 12 months and 24 months ]
  10. PDM (Patient involvement in the Decision Making process) questionnaire [ Time Frame: at 12 months and 24 months ]
  11. PHCO (Patient Health Care Orientation) questionnaire [ Time Frame: at 12 months and 24 months ]
  12. Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS) [ Time Frame: at 12 months and 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02082028

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Sponsors and Collaborators
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Study Director: Clinical Science & Operations Sanofi
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Responsible Party: Sanofi Identifier: NCT02082028    
Other Study ID Numbers: BGSTA_L_05978
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases