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

Primary Purpose

Diabetes Mellitus, Type 1 or 2

Status

Terminated

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

GlucoMe App

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 or 2 focused on measuring Glucose blood measurements, glucometer, BGM, Diabetes App

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Diabitic Unit of the Wolfson Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GlucoMe App

Arm Description

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

Outcomes

Primary Outcome Measures

Hypoglycemic and Hyperglycemic Events

Number and severity of hypoglycemic and severe hyperglycemic events

Correlation between GlucoMe and HCT recommendations

Correlation between GlucoMe and HCT recommendations for changing insulin dose and the treating physician/HCT advice.

Secondary Outcome Measures

Target HbA1C/glucose achievement

Percent of patients that achieve HbA1C/glucose targets

Full Information

NCT ID

NCT03017287

First Posted

January 9, 2017

Last Updated

September 21, 2020

Sponsor

GlucoMe

1. Study Identification

Unique Protocol Identification Number

NCT03017287

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Terminated

Why Stopped

Poor accrual

Study Start Date

January 2017 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlucoMe

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1 or 2

Keywords

Glucose blood measurements, glucometer, BGM, Diabetes App

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GlucoMe App

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

GlucoMe App

Intervention Description

Assessment of the the GlucoMe App

Primary Outcome Measure Information:

Title

Hypoglycemic and Hyperglycemic Events

Description

Number and severity of hypoglycemic and severe hyperglycemic events

Time Frame

At 12 weeks of the study

Title

Correlation between GlucoMe and HCT recommendations

Description

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 Outcome Measure Information:

Title

Target HbA1C/glucose achievement

Description

Percent of patients that achieve HbA1C/glucose targets

Time Frame

At 12 weeks of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Diabitic Unit of the Wolfson Medical Center

City

Holon

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

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

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