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Type 1 DiabetesNCT00486109

A Prospective, Randomized, Parallel Crossover Study Demonstrating Subject Wearability and Usability of the I-Port Injection Port

A study testing I-Port(TM) Injection Port in people with Type 1 Diabetes and Type 2 Diabetes, run by Patton Medical Devices at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigated wearability and usability of the I-PORT™ Injection Port (I-PORT™), a new disposable injection port through which prescribed medication is injected subcutaneously from a standard syringe or pen. Read more about this study

Who is it for?
Ages 14 to 70 years
Conditions the study is for
Type 1 Diabetes, Type 2 Diabetes
What is being tested?
I-Port(TM) Injection Port
How many people
74 participants
Where
5 sitesUnited States
Study dates
Oct 2006to Jan 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male and female subjects, 14-70 years of age, with type 1 and type 2 diabetes mellitus for a minimum of six (6) months
  • Subjects must be utilizing a regimen of at least two (2)injections daily of either Novolin®, Humulin®, NovoLog®, Humalog® or Apidra® and no more than one (1) injection of Lantus® daily using a standard syringe or insulin pen
  • Current regimen of intensified insulin therapy (defined as separate injections of basal and prandial insulin with at least three (3) insulin injections per day) for a minimum of three (3) months
  • Body Mass Index <35 kg/m2
  • HbA1c ≤ 10 %
  • If medications (other than oral anti-diabetic agents) in addition to insulin are taken at screening, the subject must be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least three (3) months prior to study enrollment
  • Subjects must be willing to provide written informed consent

Who cannot join

  • Use of Continuous Subcutaneous Insulin Infusion (CSII) at any time within the preceding three (3) months
  • History or current diagnosis of chronic diseases which in the view of the PI would interfere with adequate involvement in and completion of the requirements of the study
  • Use of short term or chronic steroids within two (2) months of entry into the study or likelihood that same might be required during the conduct of the study
  • Use of hydrochlorthiazide at doses >25 mg daily
  • Use of beta-blocker drugs
  • Regular pre-prandial doses of SC insulin >30 IU per meal
Show all 22Show fewer
  • Intake of any drug or herbal preparation which, in the evaluation of the PI, may interfere with the interpretation of clinical study results or that is known to cause clinically relevant interference with insulin action, glucose utilization or ability to detect or recover from hypoglycemia (e.g., systemic steroids)
  • History of known hypersensitivity to plastics or polymers
  • Treatment with any investigational drug within two (2) months prior to enrollment or during this study
  • Progressive fatal disease
  • History of malignancy within five (5) years of study entry(other than basal cell carcinoma)
  • Evidence of severe secondary complications of diabetes(neuropathy, nephropathy as evidenced by creatinine >1.5 mg/dL for females or >1.8 mg/dL for males, grade III or IV retinopathy or severe peripheral vascular disease)
  • Evidence of gastroparesis, orthostatic hypotension or hypoglycemia unawareness (autonomic neuropathy)
  • Myocardial infarction or stroke within the preceding six (6)months
  • Positive hepatitis B (HBsAg) and/or hepatitis C (Hep C AB)serology and/or positive HIV serology
  • History or presence of clinically significant cardiovascular, hepatic (as evidenced by ALT or AST >3 times the upper limit of normal), gastrointestinal, neurological or infectious disorders capable of altering the absorption, metabolism or elimination of drugs, or constituting a significant risk factor when using the study device
  • Anemia (hemoglobin levels <11 g/dL for females or <12 g/dL for males)
  • Pregnancy, lactation, or intention to become pregnant
  • Female subjects of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral
  • Regular alcohol intake greater than 18 units*/week, or subjects unwilling to stop alcohol for the duration of the study (* 1 unit = 8 g ethanol, ¼ liter of beer or 1 glass wine or 1 ounce of spirits)
  • PI or clinical site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted
  • A lack of compliance (including the inability to maintain a minimum of 75% compliance with study device administration) or other reasons, which in the opinion of the PI may preclude the participation of the subject in the study

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30309

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78731

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Diabetes and Endocrine Associates

    Omaha, Nebraska, 68131

  • Diabetes and Glandular Disease Clinic

    San Antonio, Texas, 78729

Other trials in United States

About this study

Official title: A Study Assessing an Injection Port for Administration of Insulin

This study investigated wearability and usability of the I-PORT™ Injection Port (I-PORT™), a new disposable injection port through which prescribed medication is injected subcutaneously from a standard syringe or pen. Additional investigation compared subject opinion towards using the I-PORT™ device compared to standard injection therapy.

Being tested
I-Port(TM) Injection Port
Keywords
Diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-Port(TM) Injection PortDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycosylated albumin levels

    Measured: 7 weeks

Secondary outcomes (1)

  1. Participants' satisfaction evaluated with standard quality of life questionnaires and adverse events related to the study device including incidents of erythema > 2cm diameter, incidence of induration > 1cm dimater and incidence of suppuration.

    Measured: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2007 (estimated)
  2. Study startOct 2006
  3. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00486109
Sponsor's protocol ID
PTN 012.1
Status last verified
Mar 2008
First submitted
12 Jun 2007
Last updated
11 Mar 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing I-Port(TM) Injection Port in people with Type 1 Diabetes and Type 2 Diabetes, run by Patton Medical Devices at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycosylated albumin levels (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00486109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2008.

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