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 Overview
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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.

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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: iBGStar
* Device: Traditional Glucometer


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iBGStar (Group A)<br>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. | Device: iBGStar<br> <br> |
| Active Comparator: Traditional Glucometer (Group B)<br>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. | Device: Traditional Glucometer<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c levels from baseline |  | baseline to six months | 
| Proportion of participants performing at least 30% of the recommended Self-Monitoring Blood Glucose tests after 6 months from randomization |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with HbA1c ≤7.5% |  | at 6 months and 12 months | 
| Average number of recommended Self-Monitoring Blood Glucose tests daily, weekly, and monthly |  | at 6 months and 12 months | 
| Mean fasting plasma glucose (FPG) and postprandial glucose (PPG) |  | at 6 months and 12 months | 
| Mean Glycemic Variability |  | at 6 months and 12 months | 
| Average Insulin Dose |  | at 6 months and 12 months | 
| Number of Daily Injections |  | at 6 months and 12 months | 
| Number of Insulin Dose Adjustments |  | at 6 months and 12 months | 
| Quality of life: Audit of Diabetes Dependent Quality of Life (ADDQOL) (young adults 18-24 years) |  | at 6 months and 12 months | 
| Diabetes Quality of Life (DQOL-Y) (adolescents 14-17 years) |  | at 6 months and 12 months | 
| Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS) |  | at 6 months and 12 months | 
| Number overall contacts between centers and participants |  | up to 12 months | 
| Type of overall contacts between centers and participants |  | up to 12 months |