Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI
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|ClinicalTrials.gov Identifier: NCT03017287|
Recruitment Status : Terminated (Poor accrual)
First Posted : January 11, 2017
Last Update Posted : September 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1 or 2||Device: GlucoMe App||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI|
|Study Start Date :||January 2017|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||August 2017|
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
- Hypoglycemic and Hyperglycemic Events [ Time Frame: At 12 weeks of the study ]Number and severity of hypoglycemic and severe hyperglycemic events
- 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.
- Target HbA1C/glucose achievement [ Time Frame: At 12 weeks of the study ]Percent of patients that achieve HbA1C/glucose targets
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017287
|Diabitic Unit of the Wolfson Medical Center|