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

GlucoMe

Status: Terminated

Conditions: Diabetes Mellitus, Type 1 or 2

Treatments: Device: GlucoMe App

Study type: Interventional

Funder types: Industry

Identifiers

NCT03017287

Clin-002-00

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

GlucoMe App

Experimental group

Description:

Self monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App

Treatment:

Device: GlucoMe App