Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI

Study Overview
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Brief Summary
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The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with uncontrolled diabetes treated with MDI.

Detailed Description
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GlucoMe is an interactive system, which provides glucose management tools to both the patient and health care team (HCT). The system includes a decision support system to be used by the HCT aiming to aid clinical decision making with mathematical models. The system does not intend to replace clinical judgement and all recommendations are to be approved by the HCT. Forty (40) diabetic patients on multiple daily insulin injection (MDI) with abnormal HbA1c and identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Patient's daily blood glucose will be measured and the GlucoMe App will give its recommendations for change in insulin dose, as well as recommendations for pre and post-meal carbohydrate and exercise. Patient's daily blood glucose levels will be followed by the HCT biweekly for 12 weeks and patients will be instructed to change their insulin doses according to the decision of the treating physician. At the end of the study, the HCT's recommendations for treatment adjustment will be compared to those of the system for both safety and efficacy. Study subjects and the HCT will be asked to complete a questionnaire regarding the GlucoMe system usability.

Official Title
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Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI

Conditions
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Diabetes Mellitus, Type 1 or 2

Intervention / Treatment
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* Device: GlucoMe App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both type 1 and type 2 diabetes HbA1c 7-11% Treated with MDI for at least 3 months Ability to use the system at home, mobile phone Exclusion Criteria: Active CAD, CVA during last 6 months Treatment with steroids or other glucose modifying drugs Chronic infection/cancer/other severe disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GlucoMe App<br>Self monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App | Device: GlucoMe App<br>* Assessment of the the GlucoMe App<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemic and Hyperglycemic Events | Number and severity of hypoglycemic and severe hyperglycemic events | At 12 weeks of the study | 
| Correlation between GlucoMe and HCT recommendations | Correlation between GlucoMe and HCT recommendations for changing insulin dose and the treating physician/HCT advice. | At 12 weeks of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target HbA1C/glucose achievement | Percent of patients that achieve HbA1C/glucose targets | At 12 weeks of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose blood measurements, glucometer, BGM, Diabetes App