User Satisfaction Using the ADI Insulin Pump

NiliMedix

Status

Completed

Conditions

Diabetes

Treatments

Device: "Adi" Insulin pump

Study type

Interventional

Funder types

Industry

Identifiers

NCT00797771

NM-HU-01

Details and patient eligibility

About

Approximately 250,000 people worldwide are currently being treated with an insulin pump. This number is growing dramatically as these devices become smaller and more user-friendly. Insulin pumps allow for tight metabolic control and lifestyle flexibility while minimizing the number of hypoglycemic events.

The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro- infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by the pressure of insulin within it to deliver preset basal profiles and patient programmed bolus of insulin through custom infusion sets, into subcutaneous tissue.

This type of device requires extensive user interaction and education in order to ensure its safety. This study was designed to test the independent home-use of the NiliMedix ADI Insulin Pump, and to evaluate user's satisfaction.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male/female age 18 years and up.
Subject is diagnosed as Type 1 Diabetes.
Pump Users for at least 6 months
HbA1c: less than 8.5%
Capable of reading pump screens in English.
Subject understands the study procedure.
Subject is willing to sign the informed consent form and comply with the study requirements.

Exclusion criteria

Major physical, motor, mental, behavioral, or psychiatric limitations.
Subject experienced a severe hypoglycemic episode that led to hospitalization during the last 6 months.
Subject experienced an episode of Ketoacidosis during the last 6 months, while using an insulin pump.
Concurrent additional major illness.
Subject objects to the study protocol.
Physician objection
Concurrent participation in other study.