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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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iBGStar (Group A)

Self-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.

Group Type EXPERIMENTAL

iBGStar

Intervention Type DEVICE

Traditional Glucometer (Group B)

Self-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.

Group Type ACTIVE_COMPARATOR

Traditional Glucometer

Intervention Type DEVICE

Interventions

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iBGStar

Intervention Type DEVICE

Traditional Glucometer

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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%
* 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)

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

14 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No