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

NCT02073188 | Completed Phase 3

• 1 other identifier: IBGST_L_05971
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 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

Study Arms (2)

iBGStar (Group A)

EXPERIMENTAL

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

Traditional Glucometer (Group B)

ACTIVE COMPARATOR

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

Interventions

iBGStar DEVICE

iBGStar (Group A)

Traditional Glucometer DEVICE

Traditional Glucometer (Group B)

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi -Aventis Administrative Office

Milan, Italy

Location

Related Publications (1)

• 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.

  PMID: 28138788 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: June 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

IT (1)