Diabetes MellitusSELF CARENCT02082028
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
A study testing BGStar and glucose meter in people with Diabetes Mellitus, run by Sanofi at 20 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- BGStar and glucose meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 20 sitesItaly
- Study dates
- 27 Jun 2012to 30 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females
- Age ≥ 45 years
- Type 2 diabetes
- First access at the diabetes clinic
- Any diabetes duration
- HbA1c >7.0 and ≤ 9.0%
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- 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
Who cannot join
- 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;
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- 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)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Investigational Site Number 016
Andria (BA)
Investigational Site Number 011
Avezzano
Investigational Site Number 006
Bergamo, 24128
Investigational Site Number 002
Brescia
Investigational Site Number 022
Catania, 95122
Investigational Site Number 001
Cusano Milanino
Investigational Site Number 013
Livorno
Investigational Site Number 015
Lucca
Investigational Site Number 004
Mariano Comense
Investigational Site Number 017
Messina
Investigational Site Number 008
Milan
Investigational Site Number 018
Naples
Investigational Site Number 021
Potenza
Investigational Site Number 020
Ragusa
Investigational Site Number 014
Ravenna
Investigational Site Number 012
Rimini, 47900
Investigational Site Number 009
Roma
Investigational Site Number 019
Terlizzi (BA)
Investigational Site Number 007
Torino
Investigational Site Number 003
Udine
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- BGStar, glucose meter
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGStarDevice
glucose meterDevice
| Study group | Role | What they receive |
|---|---|---|
| A (BGStar) | Experimental | 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. Receives: Device: BGStar |
| B (traditional approach) | Active comparator | 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. Receives: Device: glucose meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c levels from baseline
Measured: baseline to 12 months
Secondary outcomes (12)
Percentage of participants with HbA1c ≤7.0%
Measured: at 12 months and 24 months
Variation in body weight from baseline
Measured: at 12 months and 24 months
Variation in waist circumference from baseline
Measured: at 12 months and 24 months
Variation in blood pressure from baseline
Measured: at 12 months and 24 months
Variation in lipid profile from baseline
Measured: at 12 months and 24 months
Quality of life: SF12 (Health Survey) questionnaire
Measured: at 12 months and 24 months
ADDQOL (Audit of Diabetes-Dependent Quality of Life)
Measured: at 12 months and 24 months
DTSQ (Diabetes Treatment Satisfaction Questionnaire)
Measured: at 12 months and 24 months
ABIM-14 (American Board of Internal Medicine satisfaction questionnaire)
Measured: at 12 months and 24 months
PDM (Patient involvement in the Decision Making process) questionnaire
Measured: at 12 months and 24 months
PHCO (Patient Health Care Orientation) questionnaire
Measured: at 12 months and 24 months
Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)
Measured: at 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study start27 Jun 2012
- Primary completion30 Jul 2015
- Study completion30 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Science & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082028
- Sponsor's protocol ID
- BGSTA_L_05978
- Acronym
- SELF CARE
- Status last verified
- May 2017
- First submitted
- 6 Mar 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02082028
- Acronym / sponsor ID
- SELF CARE / BGSTA_L_05978
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2012 (actual)
- Primary completion
- 30 Jul 2015 (actual)
- Study completion
- 30 Jul 2015 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (BGStar) | Experimental | Device: BGStarPatients 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. |
| B (traditional approach) | Active comparator | Device: glucose meterUsual 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females
- Age ≥ 45 years
- Type 2 diabetes
- First access at the diabetes clinic
- Any diabetes duration
Key exclusion criteria (10 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGStar | Device | A (BGStar) |
| glucose meter | Device | B (traditional approach) |
Primary outcome
Change in HbA1c levels from baseline
Time frame: baseline to 12 months
12 secondary outcomes
Percentage of participants with HbA1c ≤7.0%
Time frame: at 12 months and 24 months
Variation in body weight from baseline
Time frame: at 12 months and 24 months
Variation in waist circumference from baseline
Time frame: at 12 months and 24 months
Variation in blood pressure from baseline
Time frame: at 12 months and 24 months
Variation in lipid profile from baseline
Time frame: at 12 months and 24 months
Quality of life: SF12 (Health Survey) questionnaire
Time frame: at 12 months and 24 months
ADDQOL (Audit of Diabetes-Dependent Quality of Life)
Time frame: at 12 months and 24 months
DTSQ (Diabetes Treatment Satisfaction Questionnaire)
Time frame: at 12 months and 24 months
ABIM-14 (American Board of Internal Medicine satisfaction questionnaire)
Time frame: at 12 months and 24 months
PDM (Patient involvement in the Decision Making process) questionnaire
Time frame: at 12 months and 24 months
PHCO (Patient Health Care Orientation) questionnaire
Time frame: at 12 months and 24 months
Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)
Time frame: at 12 months and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Science & Operations study director
Sanofi
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BGStar and glucose meter in people with Diabetes Mellitus, run by Sanofi at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c levels from baseline (time frame: baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.