- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03017287
Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Holon, Israel
- Diabitic Unit of the Wolfson Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Clin-002-00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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