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

GlucoMe40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1 or 2

Interventions

GlucoMe AppDEVICE

Assessment of the the GlucoMe App

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Both type 1 and type 2 diabetes 2. HbA1c 7-11% 3. Treated with MDI for at least 3 months 4. Ability to use the system at home, mobile phone Exclusion Criteria: 1. Active CAD, CVA during last 6 months 2. Treatment with steroids or other glucose modifying drugs 3. Chronic infection/cancer/other severe disease

Locations (1)

Diabitic Unit of the Wolfson Medical Center

Holon, Israel

Outcomes

Primary Outcomes

Hypoglycemic and Hyperglycemic Events

Number and severity of hypoglycemic and severe hyperglycemic events

Time frame: 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.

Time frame: At 12 weeks of the study

Secondary Outcomes

Target HbA1C/glucose achievement

Percent of patients that achieve HbA1C/glucose targets

Time frame: At 12 weeks of the study

Data from ClinicalTrials.gov

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