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

Not Applicable

Terminated

• Conditions: Diabetes Mellitus, Type 1 or 2
• Interventions: Device: GlucoMe App

• Registration Number: NCT03017287
• Lead Sponsor: GlucoMe

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-11
• Primary Completion: 2017-05
• Study Completion: 2017-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GlucoMe App	GlucoMe App	Self monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Target HbA1C/glucose achievement	At 12 weeks of the study	Percent of patients that achieve HbA1C/glucose targets

Trial Locations

Locations (1)

Diabitic Unit of the Wolfson Medical Center; 🇮🇱 Holon, Israel