Type 2 Diabetes MellitusNCT01535612
Study of PaQ™ (a Simple Patch on Insulin Delivery Device) in Patients With Type 2 Diabetes Mellitus
A study testing PaQ™ insulin infusion device in people with Type 2 Diabetes Mellitus, run by CeQur Corporation at 1 site in Austria.
Trial summary
The purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes (T2DM) who is currently treated with basal/bolus insulin therapy, to use PaQ™ (a simple patch on insulin delivery device) to control his/her blood glucose. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- PaQ™ insulin infusion device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2012to Sep 2012
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female patient's ≥ 30 ≤ 65 years of age.
- Clinical confirmation of T2DM diagnosis by history and medication usage or glucose tolerance test.
- Currently treated with insulin using a basal/bolus regimen with or without concurrent use of OADs (metformin and/or glitazone).
- Currently on a stable insulin regimen "as judged by the investigator" (using an estimate of their basal dose of insulin does not fluctuate by more than ±10% every day) and if he/she is receiving a concurrent oral agent, the dose has remained unchanged for the last 30 days.
- Currently uses between 20 to 50 units/day basal insulin.
Who cannot join
- Uncontrolled hyperglycemia, HbA1c > 9.0% requiring adjustment to his/her insulin regimen.
- Treated with premixed insulin, or neutral protamine hagedorn (NPH)/glargine/detemir insulin without use of bolus/meal time insulin.
- Patient has had an episode of severe (assisted) hypoglycemia within the past 30 days.
- Currently treated with sulfonylurea or incretin-based therapy [glucagon-like peptide-1(GLP-1) agonist or dipeptidyl peptidase-4 (DPP-4) inhibitor].
- Total daily dose (TDD) of insulin is >100 units/day.
- Have a meal-time bolus doses that exceeds the capacity of the bolus Insulin Reservoir at any given meal.
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- Have existing dermal irritation on their abdomen or have known hypersensitivity to skin adhesives.
- Taking or has taken prednisone or cortisone medications in the previous 30 days.
- Pregnant or is planning to become pregnant during the study period.
- Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.
- Unable to follow the study clinical investigational plan (CIP)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Evaluating the Feasibility of Use and Performance of PaQ™ in Patients With Type 2 Diabetes Mellitus Who Are Currently Treated With Basal/Bolus Insulin Therapy
The purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes (T2DM) who is currently treated with basal/bolus insulin therapy, to use PaQ™ (a simple patch on insulin delivery device) to control his/her blood glucose.
Read the detailed description
This is a single center, open label, feasibility of use and performance evaluation of PaQ™ (using insulin aspart) in patients with T2DM who are currently receiving basal/bolus insulin therapy with or without oral anti-diabetic drugs (OADs) for glycemic control. The patient's participation in the study is comprised of four phases: screening, baseline evaluation, transition to PaQ™ use, and PaQ™ treatment period. The use of these phases will allow an orderly transition to PaQ™ treatment as well as a reliable construct from which to interpret the final data.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- PaQ™ insulin infusion device
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaQ™ insulin infusion deviceDevice
Basal/bolus insulin therapy administered by CSII for 4 weeks. First two weeks is transition period to identify correct basal rate for the patient, second 2 weeks is treatment period to evaluate efficacy of CSII device.
| Study group | Role | What they receive |
|---|---|---|
| PaQ™ insulin infusion device | Experimental | PaQ™ insulin infusion device which delivers rapid acting insulin. Receives: Device: PaQ™ insulin infusion device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device
Measured: End of two week transition period
Secondary outcomes (9)
Insulin usage
Average daily amount of basal insulin and meal time bolus insulin will be calculated
Measured: End of two baseline period and end of 2 week treatment period
7-point blood glucose reading
7 - points are pre and 1.5 hours post each meal and at bedtime
Measured: Twice per week during baseline period (weeks 1 & 2) and PaQ™ Treatment period (weeks 5 & 6)
Glucose variability
Continuous glucose monitoring (CGM) will be performed. Data stored in the CGM will be transferred to a computer at the end of each study period. Glucose variability during each time period will be calculated.
Measured: During baseline and PaQ™ treatment period
Glucose exposure
Continuous glucose monitoring (CGM) will be performed. Data stored in the CGM will be transferred to a computer at the end of each study period. Glucose exposure during each time period will be calculated.
Measured: During baseline and PaQ™ treatment period
Glucose Stability
Continuous glucose monitoring (CGM) will be performed. Data stored in the CGM will be transferred to a computer at the end of each study period. Glucose stability during each time period will be calculated.
Measured: During baseline and PaQ™ Treatment Period
Infection at cannula insertion site
Measured: During transition and PaQ™ treatment period
Occurence of adverse experiences and the number and severity of hypoglycemic episodes
Measured: During baseline, transition and PaQ™ treatment period
Quality of Life Questionnaire
Measured: At the end of the study
Dermal Irritation
Measured: During transition and PaQ™ treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CeQur Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Diabetes Center at Park Nicollet
- Responsible party
- Sponsor
- Investigators
- Thomas Pieber, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535612
- Sponsor's protocol ID
- CQR-09001
- Status last verified
- Jul 2016
- First submitted
- 2 Sep 2011
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Published in Diabetes Care - Volume 37, May 2014, pages 1476-1479
Publications
Mader JK, Lilly LC, Aberer F, Korsatko S, Strock E, Mazze RS, Damsbo P, Pieber TR. A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes. Diabetes Care. 2014 May;37(5):1476-9. doi: 10.2337/dc13-2238. Epub 2014 Mar 5.
PubMed 24598242
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Feasibility of Use and Performance of PaQ™ in Patients With Type 2 Diabetes Mellitus Who Are Currently Treated With Basal/Bolus Insulin Therapy
- ClinicalTrials.gov ID
- NCT01535612
- Acronym / sponsor ID
- CQR-09001
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CeQur CorporationIndustry (pharma, biotech, devices)
- Collaborators
- International Diabetes Center at Park Nicollet
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes (T2DM) who is currently treated with basal/bolus insulin therapy, to use PaQ™ (a simple patch on insulin delivery device) to control his/her blood glucose.
Detailed description
This is a single center, open label, feasibility of use and performance evaluation of PaQ™ (using insulin aspart) in patients with T2DM who are currently receiving basal/bolus insulin therapy with or without oral anti-diabetic drugs (OADs) for glycemic control. The patient's participation in the study is comprised of four phases: screening, baseline evaluation, transition to PaQ™ use, and PaQ™ treatment period. The use of these phases will allow an orderly transition to PaQ™ treatment as well as a reliable construct from which to interpret the final data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PaQ™ insulin infusion device | Experimental | Device: PaQ™ insulin infusion devicePaQ™ insulin infusion device which delivers rapid acting insulin. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male/female patient's ≥ 30 ≤ 65 years of age.
- Clinical confirmation of T2DM diagnosis by history and medication usage or glucose tolerance test.
- Currently treated with insulin using a basal/bolus regimen with or without concurrent use of OADs (metformin and/or glitazone).
- Currently on a stable insulin regimen "as judged by the investigator" (using an estimate of their basal dose of insulin does not fluctuate by more than ±10% every day) and if he/she is receiving a concurrent oral agent, the dose has remained unchanged for the last 30 days.
- Currently uses between 20 to 50 units/day basal insulin.
Key exclusion criteria (11 listed)
- Uncontrolled hyperglycemia, HbA1c > 9.0% requiring adjustment to his/her insulin regimen.
- Treated with premixed insulin, or neutral protamine hagedorn (NPH)/glargine/detemir insulin without use of bolus/meal time insulin.
- Patient has had an episode of severe (assisted) hypoglycemia within the past 30 days.
- Currently treated with sulfonylurea or incretin-based therapy [glucagon-like peptide-1(GLP-1) agonist or dipeptidyl peptidase-4 (DPP-4) inhibitor].
- Total daily dose (TDD) of insulin is >100 units/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 |
|---|---|---|
| PaQ™ insulin infusion deviceBasal/bolus insulin therapy administered by CSII for 4 weeks. First two weeks is transition period to identify correct basal rate for the patient, second 2 weeks is treatment period to evaluate efficacy of CSII device. | Device | PaQ™ insulin infusion device |
Primary outcome
Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device
Time frame: End of two week transition period
9 secondary outcomes
Insulin usage
Time frame: End of two baseline period and end of 2 week treatment period
7-point blood glucose reading
Time frame: Twice per week during baseline period (weeks 1 & 2) and PaQ™ Treatment period (weeks 5 & 6)
Glucose variability
Time frame: During baseline and PaQ™ treatment period
Glucose exposure
Time frame: During baseline and PaQ™ treatment period
Glucose Stability
Time frame: During baseline and PaQ™ Treatment Period
Infection at cannula insertion site
Time frame: During transition and PaQ™ treatment period
Occurence of adverse experiences and the number and severity of hypoglycemic episodes
Time frame: During baseline, transition and PaQ™ treatment period
Quality of Life Questionnaire
Time frame: At the end of the study
Dermal Irritation
Time frame: During transition and PaQ™ treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Results publication: PubMed 24598242Mader JK, Lilly LC, Aberer F, Korsatko S, Strock E, Mazze RS, Damsbo P, Pieber TR. A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes. Diabetes Care. 2014 May;37(5):1476-9. doi: 10.2337/dc13-2238. Epub 2014 Mar 5.
- Individual participant dataSharing planned: Yes. Published in Diabetes Care - Volume 37, May 2014, pages 1476-1479
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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.
Thomas Pieber, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PaQ™ insulin infusion device in people with Type 2 Diabetes Mellitus, run by CeQur Corporation at 1 site in Austria.
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 5 inclusion and 11 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 27 Jul 2016. 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 Austria. 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?
Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device (time frame: End of two week transition period). 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 NCT01535612, 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 27 Jul 2016.