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

Withdrawn

• Conditions: Type 1 or 2 Diabetics

• Registration Number: NCT01978990
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-03
• Study First Submitted QC: 2013-11-03
• Study First Posted: 2013-11-08
• Status Verified: 2017-03
• Study Start: 2018-01
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recommendation accuracy	three months	Recommendation accuracy: over 80% correspondence between the corrective actions recommended by the system and the corrective actions decided upon by the physician.