Type 1 Diabetes MellitusPhase 2/3NCT00837512
Insulin Delivery Using Microneedles in Type 1 Diabetes
A Phase 2/3 study testing Microneedle and Subcutaneous insulin catheter in people with Type 1 Diabetes Mellitus, run by Emory University at 1 site in United States.
Trial summary
The goal of this study is to determine if microneedles can effectively and painlessly deliver insulin to children and young adults with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Microneedle and Subcutaneous insulin catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jul 2013
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ≥ 8 years of age
- <19 years of age
- Type 1 Diabetes for at least 2 years
- Uses a conventional, FDA-approved insulin pump for the past year
- Uses Lispro insulin
- Mean hemoglobin A1C ≤ 8.5 % for the past year
- Body mass index ≤ 85th percentile for age
- Understand and be willing to adhere to the study protocol
Who cannot join
- Type 2 Diabetes
- Acanthosis nigricans
- Clinically significant major organ system disease
- On glucocorticoid therapy
- Insulin requirement ≥ 150 U/day
- Illness on the day of the study
- Cognitive impairment (IQ < 85 or > 2 grades behind age-appropriate grade)
- Pregnant or breast-feeding (if female).
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to determine if microneedles can effectively and painlessly deliver insulin to children and young adults with type 1 diabetes.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Microneedle, Subcutaneous insulin catheter
- Keywords
- microneedle continuous subcutaneous insulin infusion
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedleDevice
Microneedle used to deliver insulin at a depth less than 900 micrometers
Subcutaneous insulin catheterDevice
Also called subcutaneous insulin infusion catheter
Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
| Study group | Role | What they receive |
|---|---|---|
| Microneedle | Experimental | Microneedle used to deliver insulin at a depth less than 900 micrometers Receives: Device: Microneedle |
| Subcutaneous insulin catheter | Active comparator | Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) Receives: Device: Subcutaneous insulin catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset Time (Tmax)
Average time to peak insulin concentration
Measured: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Eric Felner, MD, MSCR, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837512
- Sponsor's protocol ID
- 1348-2005
- Other IDs
- FWA00005792
- Status last verified
- Nov 2013
- First submitted
- 4 Feb 2009
- Last updated
- 8 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Norman JJ, Brown MR, Raviele NA, Prausnitz MR, Felner EI. Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2013 Sep;14(6):459-65. doi: 10.1111/pedi.12031. Epub 2013 Mar 21.
PubMed 23517449
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Delivery Using Microneedles in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00837512
- Acronym / sponsor ID
- 1348-2005
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- microneedle continuous subcutaneous insulin infusion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Sep 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Posted 8 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine if microneedles can effectively and painlessly deliver insulin to children and young adults with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedle | Experimental | Device: MicroneedleMicroneedle used to deliver insulin at a depth less than 900 micrometers |
| Subcutaneous insulin catheter | Active comparator | Device: Subcutaneous insulin catheterSubcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- ≥ 8 years of age
- <19 years of age
- Type 1 Diabetes for at least 2 years
- Uses a conventional, FDA-approved insulin pump for the past year
- Uses Lispro insulin
Key exclusion criteria (8 listed)
- Type 2 Diabetes
- Acanthosis nigricans
- Clinically significant major organ system disease
- On glucocorticoid therapy
- Insulin requirement ≥ 150 U/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroneedleMicroneedle used to deliver insulin at a depth less than 900 micrometers | Device | Microneedle |
| Subcutaneous insulin catheterAlso: subcutaneous insulin infusion catheterSubcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) | Device | Subcutaneous insulin catheter |
Primary outcome
Onset Time (Tmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours
Average time to peak insulin concentration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23517449Norman JJ, Brown MR, Raviele NA, Prausnitz MR, Felner EI. Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2013 Sep;14(6):459-65. doi: 10.1111/pedi.12031. Epub 2013 Mar 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Microneedle and Subcutaneous insulin catheter in people with Type 1 Diabetes Mellitus, run by Emory University at 1 site 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 8 inclusion and 8 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 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Onset Time (Tmax) (time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours). 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 NCT00837512, which also lists 1 linked publication.
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 8 Jan 2014.