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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01978990
Enrollment
0
Registered
2013-11-08
Start date
2018-01-31
Completion date
2019-10-31
Last updated
2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 or 2 Diabetics

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.

Interventions

None listed

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recommendation accuracythree monthsRecommendation accuracy: over 80% correspondence between the corrective actions recommended by the system and the corrective actions decided upon by the physician.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026