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

September 21, 2020 updated by: GlucoMe
The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with uncontrolled diabetes treated with MDI.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel
        • Diabitic Unit of the Wolfson Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GlucoMe App
Self monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App
Device: GlucoMe App
Assessment of the the GlucoMe App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycemic and Hyperglycemic Events
Time Frame: At 12 weeks of the study
Number and severity of hypoglycemic and severe hyperglycemic events
At 12 weeks of the study
Correlation between GlucoMe and HCT recommendations
Time Frame: At 12 weeks of the study
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
Time Frame: At 12 weeks of the study
Percent of patients that achieve HbA1C/glucose targets
At 12 weeks of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlucoMe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 9, 2017

First Posted (ESTIMATE)

January 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clin-002-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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