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OpenTrials
Completed

NCT Number: NCT00797771

User Satisfaction Using the ADI Insulin Pump

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schnieder Children's Medical Center

Petah Tikva, 49202, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"Adi" Insulin pump

Device

insulin delivery will be defined by the physician

Primary outcomes

  1. User satisfaction regarding the "Adi" pump functioning will be evaluated by questionnaire. The questionnaire will be administrated during the last study visit

    Time frame: End of study

Secondary outcomes

  1. Number of severe hypoglycemic events

    Time frame: during the study

Sponsors and collaborators

Lead sponsor

NiliMedix

Industry

Registry information

Official study title

Evaluation of User Satisfaction Using the ADI Insulin Pump

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Nov 25, 2008
Registry last updated
Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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