Diabetes Mellitus, Type 1 or 2
Conditions
Keywords
Glucose blood measurements, glucometer, BGM, Diabetes App
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.
Interventions
DEVICEGlucoMe App
Assessment of the the GlucoMe App
Sponsors
GlucoMe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Both type 1 and type 2 diabetes 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
1. Active CAD, CVA during last 6 months 2. Treatment with steroids or other glucose modifying drugs 3. Chronic infection/cancer/other severe disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemic and Hyperglycemic Events | At 12 weeks of the study | Number and severity of hypoglycemic and severe hyperglycemic events |
| Correlation between GlucoMe and HCT recommendations | At 12 weeks of the study | Correlation between GlucoMe and HCT recommendations for changing insulin dose and the treating physician/HCT advice. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target HbA1C/glucose achievement | At 12 weeks of the study | Percent of patients that achieve HbA1C/glucose targets |
Countries
Israel
Outcome results
None listed