Assessment of a Health Informatics System on Insulin-treated Diabetic Patients

Modern medicine provides many solutions that are intended to help control the patient's blood glucose level: insulin and other medications to lower it, glucose tablets or glucagone to raise it when it gets dangerously low, glucometers to quickly measure the blood glucose level, pumps and pens to inject insulin or other injectable medicine, etc.The objective of this trial is proving the concept and the feasibility of using a medical informatics system comprised of computer hardware, software and a smartphone application to achieve better outcomes.

Study Overview

• Status: Withdrawn
• Conditions: Type 1 or 2 Diabetics

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Type 1 or 2 diabetics diagnosed at least 12 months prior to study enrollment

Description

Inclusion Criteria:

1. Type 1 or 2 diabetics diagnosed at least 12 months prior to study enrollment.
2. Treated with insulin (basal only or basal + bolus) for at least 6 months prior to study enroment.
3. HbA1c lower than 12% With or without other anti-diabetic drugs.
4. 18-80 years of age.
5. Male or female.
6. Own an Android phone.
7. Able to handle mobile applications, technology-friendly
8. Able and willing to understand and comply with the study procedures.
9. Provide signed written and informed consent form prior to enrolment in the study.

Exclusion Criteria:

1. Using an insulin pump.
2. Pregnant or planning to be pregnant within the period of the study.
3. Active substance abuse.
4. Psychosis or schizophrenia under active care.
5. Uncorrected severe hearing or visual impairment.
6. Any other condition that is not acceptable to the investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Diabetes Management System , blood glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommendation accuracy	Recommendation accuracy: over 80% correspondence between the corrective actions recommended by the system and the corrective actions decided upon by the physician.	three months

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: November 3, 2013
• First Submitted That Met QC Criteria: November 3, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 0406-13- HMO-CTIL