NCT03017287

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

January 9, 2017

Last Update Submit

September 21, 2020

Conditions

Diabetes Mellitus, Type 1 or 2

Keywords

Glucose blood measurements, glucometer, BGM, Diabetes App

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Target HbA1C/glucose achievement

    At 12 weeks of the study

Study Arms (1)

GlucoMe App

EXPERIMENTAL

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

Device: GlucoMe App

Interventions

GlucoMe AppDEVICE

Assessment of the the GlucoMe App

GlucoMe App

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Active CAD, CVA during last 6 months
  • Treatment with steroids or other glucose modifying drugs
  • Chronic infection/cancer/other severe disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabitic Unit of the Wolfson Medical Center

Holon, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 11, 2017

Study Start

January 1, 2017

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

September 23, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)