Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI
NCT ID: NCT03017287
Last Updated: 2020-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
40 participants
INTERVENTIONAL
2017-01-31
2017-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GlucoMe App
Self monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App
GlucoMe App
Assessment of the the GlucoMe App
Interventions
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GlucoMe App
Assessment of the the GlucoMe App
Eligibility Criteria
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Inclusion Criteria
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
2. Treatment with steroids or other glucose modifying drugs
3. Chronic infection/cancer/other severe disease
18 Years
80 Years
ALL
No
Sponsors
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GlucoMe
INDUSTRY
Responsible Party
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Locations
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Diabitic Unit of the Wolfson Medical Center
Holon, , Israel
Countries
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Other Identifiers
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Clin-002-00
Identifier Type: -
Identifier Source: org_study_id
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