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CompletedNCT00797771Updated Jun 9, 2011

User Satisfaction Using the ADI Insulin Pump

An interventional study of "Adi" Insulin pump in Diabetes, sponsored by NiliMedix. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-09.

Sponsored by NiliMedix · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetes

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Keywords

  • Insulin delivery
03

In context

Diabetes Mellitus

11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 20 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

NiliMedix is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    A

    "Adi" insulin pump users

    Device: "Adi" Insulin pump

Interventions

  • Device"Adi" Insulin pump

    insulin delivery will be defined by the physician

06

What researchers measure

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

07

Study locations

1 site
  • Schnieder Children's Medical Center
    Petah Tikva, 49202, Israel
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2008, a primary completion of Nov 2009 and a completion of Jan 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2008
First posted
Nov 25, 2008
Start
Dec 2008
Primary completionActual
Nov 2009
CompletionActual
Jan 2010
Last update
Jun 9, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00797771
Lead sponsor
NiliMedix
First posted
Nov 25, 2008
Start date
Dec 2008
Primary completion
Nov 2009
Completion
Jan 2010
Last update
Jun 9, 2011

Study contacts

Shlomit Shalitin, MD
principal investigator · Schnieder Children's Medical Center Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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