Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI

Diabetes Mellitus, Type 1 or 2 Clinical Trial

Official title:

Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03017287
• Other study ID #: Clin-002-00
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: August 2017

Study information

• Verified date: September 2020
• Source: GlucoMe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 1 or 2

Intervention

Device:
• GlucoMe App
Assessment of the the GlucoMe App

Locations

Country	Name	City	State
Israel	Diabitic Unit of the Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
GlucoMe

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycemic and Hyperglycemic Events	Number and severity of hypoglycemic and severe hyperglycemic events	At 12 weeks of the study
Primary	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	Target HbA1C/glucose achievement	Percent of patients that achieve HbA1C/glucose targets	At 12 weeks of the study