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Diabetes MellitusPhase 3iNew TrendNCT02073188

Comparative Study of a Smartphone-Linked Self-Monitoring System Versus a Traditional One for Improving Metabolic Control and Compliance to Self-Monitoring of Blood Glucose

A Phase 3 study testing iBGStar and Traditional Glucometer in people with Diabetes Mellitus, run by Sanofi at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to demonstrate the superiority of iBGstar as a component of the diabetes treatment vs. traditional blood glucose self-monitoring system for improving glycemic control after 6 months in young patients with type 1 diabetes. Read more about this study

Who is it for?
Ages 14 to 24 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
iBGStar and Traditional Glucometer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
1 siteItaly
Study dates
Jun 2012to Sep 2014
Phase
Phase 3
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 14 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Type 1 diabetes
  • Males and females
  • Age between 14-24 years
  • Any diabetes duration
  • Cared for by the diabetes center for at least 1 year
  • HbA1c ≥ 8%
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  • Basal bolus treatment (any insulin)
  • Poor compliance with Self-Monitoring of Blood Glucose (less than 30% of the recommended Blood Glucose measurements recorded in the glucose meter in the two previous weeks, i.e. <16 Blood Glucose measurements in the last two weeks)
  • Written informed consent obtained from patient or legal representative (for minor)

Who cannot join

  • Treatment with other insulin regimen or Continuous Subcutaneous Insulin Infusion
  • 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
  • Patients with high likelihood of being unavailable for 6 and/or 12 months visits
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  • Subject is the investigator, 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
  • Severe visual or dexterity impairment
  • Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
  • Pregnant or breast-feeding women
  • Subjects unlikely or unable to comply with the Protocol requirements

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Sanofi -Aventis Administrative Office

    Milan

Other trials in Italy

About this study

Official title: Comparative Efficacy of iBGStar Glucose Meter vs. Traditional Glucose Monitoring in Improving Metabolic Control and Compliance Towards Self-Monitoring of Blood Glucose in Young Patients With Type 1 Diabetes

The purpose of this study is to demonstrate the superiority of iBGstar as a component of the diabetes treatment vs. traditional blood glucose self-monitoring system for improving glycemic control after 6 months in young patients with type 1 diabetes. The study is intended also to demonstrate the superiority of iBGStar as a component of the diabetes treatment vs. usual blood glucose self-monitoring system for improving the compliance to self monitoring of blood glucose after 6 months.

Read the detailed description

The planned study duration will be 20 months (5 quarters) with screening/enrollment of 7 months, followed by 2-3 weeks of a qualification phase, a 6 month experimental phase, plus a 6 month follow-up in the post-trial observational phase.

Being tested
iBGStar, Traditional Glucometer
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iBGStarDevice

  • Traditional GlucometerDevice

Study groups in NCT02073188
Study groupRoleWhat they receive
iBGStar (Group A)ExperimentalSelf-Monitoring Blood Glucose will be managed with iBGStar and iBGStar Diabetes Manager Application (App) uploaded on iPhone for all duration of the study (6 months of experimental phase plus 6-months of observational phase). In the first 3 months, the patients in Group A will send their glycemic test values and notes by mail to the physician through Diabetes Manager App every 2 weeks. Afterwards until the visit V2 (six months), the patients in Group A will send their glycemic test values and notes by mail monthly. 9 reports in total.
Receives: Device: iBGStar
Traditional Glucometer (Group B)Active comparatorSelf-Monitoring Blood Glucose will be managed with a traditional glucometer according to usual care for the first 6 months (experimental phase). In the 6 months post-trial follow-up (observational phase), Self-Monitoring Blood Glucose will be managed with iBGStar and iBGStar Diabetes Manager App.
Receives: Device: Traditional Glucometer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c levels from baseline

    Measured: baseline to six months

  2. Proportion of participants performing at least 30% of the recommended Self-Monitoring Blood Glucose tests after 6 months from randomization

    Measured: at 6 months

Secondary outcomes (12)

  1. Percentage of participants with HbA1c ≤7.5%

    Measured: at 6 months and 12 months

  2. Average number of recommended Self-Monitoring Blood Glucose tests daily, weekly, and monthly

    Measured: at 6 months and 12 months

  3. Mean fasting plasma glucose (FPG) and postprandial glucose (PPG)

    Measured: at 6 months and 12 months

  4. Mean Glycemic Variability

    Measured: at 6 months and 12 months

  5. Average Insulin Dose

    Measured: at 6 months and 12 months

  6. Number of Daily Injections

    Measured: at 6 months and 12 months

  7. Number of Insulin Dose Adjustments

    Measured: at 6 months and 12 months

  8. Quality of life: Audit of Diabetes Dependent Quality of Life (ADDQOL) (young adults 18-24 years)

    Measured: at 6 months and 12 months

  9. Diabetes Quality of Life (DQOL-Y) (adolescents 14-17 years)

    Measured: at 6 months and 12 months

  10. Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)

    Measured: at 6 months and 12 months

  11. Number overall contacts between centers and participants

    Measured: up to 12 months

  12. Type of overall contacts between centers and participants

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2014 (estimated)
  2. Study startJun 2012
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

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 3
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02073188
Sponsor's protocol ID
IBGST_L_05971
Acronym
iNew Trend
Status last verified
Apr 2016
First submitted
25 Feb 2014
Last updated
14 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Di Bartolo P, Nicolucci A, Cherubini V, Iafusco D, Scardapane M, Rossi MC. Young patients with type 1 diabetes poorly controlled and poorly compliant with self-monitoring of blood glucose: can technology help? Results of the i-NewTrend randomized clinical trial. Acta Diabetol. 2017 Apr;54(4):393-402. doi: 10.1007/s00592-017-0963-4. Epub 2017 Jan 30.

    PubMed 28138788

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing iBGStar and Traditional Glucometer in people with Diabetes Mellitus, run by Sanofi at 1 site 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 12 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02073188, which also lists 1 linked publication.

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 14 Apr 2016.

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