Type 2 Diabetes MellitusNCT02158078
A Prospective Observational Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus, run by CeQur Corporation at 1 site in Austria.
Trial summary
The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- PaQ® Insulin Delivery Device
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2014to Nov 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twenty five (25) individuals with T2DM who have an A1C of 7.0% to 11.0%, inclusive, at Screening (Visit 1) will be recruited at one investigative site.
Who may be able to join
- Is at least 18 years of age
- Has a clinical diagnosis of T2DM, as determined by clinical history and medication usage
- Has an A1C ≥ 7.0% and ≤ 11.0%;
- Is treated with basal-bolus insulin therapy (at least 2 injections per day) with or without OADs, and/or glucagon-like peptide-1 (GLP-1) agonist for at least 3 months and has not had a change (addition or discontinuation of existing drug or change in dose) in their OADs for the last 8 weeks
- Determined by the investigator that insulin requirements to achieve glycemic targets can be met by the insulin capacity of the PaQ device
- If on concomitant metformin, has serum creatinine <1.5 mg/dL (male) or <1.4 mg/dL (female)
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- If female, and of child-bearing potential, has a negative urine pregnancy test at screening and must be using adequate means of contraception as determined by the Investigator
- Is clinically euthyroid as judged by the Investigator
- Is able to understand and sign the required study documents and comply with the clinical investigational plan (CIP) requirements
- Is deemed capable by the Investigator to perform the requirements of the CIP, including use of PaQ, frequent self-monitoring of blood glucose
Who cannot join
- Is poorly compliant with the currently prescribed diabetes regimen, as determined by the Investigator
- Is poorly compliant with prescribed self-monitoring of blood glucose, as determined by the Investigator
- Is currently taking or has taken sulfonylureas within the last 2 months
- Has a BMI greater than 40 kg/m2
- Has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months
- Has existing dermal irritation/inflammation over the abdominal area that may interfere with use of PaQ, as determined by the Investigator
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- Has known clinically significant hypersensitivity to skin adhesives
- Is female and if of child-bearing potential, is pregnant, lactating, or planning to become pregnant
- Is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route (inhaled with low systemic exposure is permitted)
- Currently abuses drugs or alcohol or has a history of abuse that in the Investigator's opinion would cause the individual to be non-compliant
- Has received any investigational drug within 1 month
- Has donated blood within 30 days
- Has any significant medical condition (including current or past history of cardiovascular disease), laboratory findings, or medical history that in the Investigator's opinion may affect successful completion of the study and/or personal well-being
- Is an immediate family member (spouse, parent, child, or sibling) of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Center, Post-Market Observational Study to Assess the Efficacy, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).
Read the detailed description
This is a prospective, single center, post-market observational study to assess the efficacy, safety, and patient reported outcomes of insulin delivery with PaQ® in patients with type 2 diabetes mellitus (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 three phases: screening/baseline evaluation, transition to PaQ use and optimization, 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 Delivery Device
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Insulin, Continuous subcutaneous insulin infusion (CSII), Insulin pumps
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaQ® Insulin Delivery DeviceDevice
PaQ is a 3 day insulin delivery device. Utilizes U 100 rapid-acting insulin. Provides basal insulin at preset basal doses and bolus insulin (in 2 unit increments) with a push of a button.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) from baseline at Week 12
Measured: 12 weeks
Secondary outcomes (7)
Change in A1C from baseline at Week 8
Measured: 8 weeks
Change in fasting plasma glucose from baseline at end of study week 12
Measured: 12 weeks
Change in 7-point blood glucose profiles and 1.5-2 hour postprandial blood glucose excursions (average and by meal) from baseline at week 12
Measured: 12 weeks
Change in insulin dose (total, basal, and bolus) from Baseline at week 12
Measured: 12 weeks
Change in body weight from baseline at Week 12
Measured: 12 weeks
Occurrence of hypoglycemia, adverse events, and/or dermal irritation at PaQ application site
Measured: Throughout the study
Change in measures of PROs from baseline at Week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Terminated to allow continued optimization of the product.
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- CeQur Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Pieber, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158078
- Sponsor's protocol ID
- CQR13002
- Status last verified
- Jul 2016
- First submitted
- 4 Jun 2014
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: No plan to share individual data sets, but will publish results.
Publications
Mader JK, Lilly LC, Aberer F, Poettler T, Johns D, Trautmann M, Warner JL, Pieber TR. Improved glycaemic control and treatment satisfaction with a simple wearable 3-day insulin delivery device among people with Type 2 diabetes. Diabet Med. 2018 Oct;35(10):1448-1456. doi: 10.1111/dme.13708. Epub 2018 Jul 5.
PubMed 29888811
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Post-Market Observational Study to Assess the Efficacy, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02158078
- Acronym / sponsor ID
- CQR13002
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Insulin, Continuous subcutaneous insulin infusion (CSII), Insulin pumps
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated to allow continued optimization of the product.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- CeQur CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 6 Jun 2014 (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 the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).
Detailed description
This is a prospective, single center, post-market observational study to assess the efficacy, safety, and patient reported outcomes of insulin delivery with PaQ® in patients with type 2 diabetes mellitus (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 three phases: screening/baseline evaluation, transition to PaQ use and optimization, 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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty five (25) individuals with T2DM who have an A1C of 7.0% to 11.0%, inclusive, at Screening (Visit 1) will be recruited at one investigative site.
Key inclusion criteria (10 listed)
- Is at least 18 years of age
- Has a clinical diagnosis of T2DM, as determined by clinical history and medication usage
- Has an A1C ≥ 7.0% and ≤ 11.0%;
- Is treated with basal-bolus insulin therapy (at least 2 injections per day) with or without OADs, and/or glucagon-like peptide-1 (GLP-1) agonist for at least 3 months and has not had a change (addition or discontinuation of existing drug or change in dose) in their OADs for the last 8 weeks
- Determined by the investigator that insulin requirements to achieve glycemic targets can be met by the insulin capacity of the PaQ device
Key exclusion criteria (14 listed)
- Is poorly compliant with the currently prescribed diabetes regimen, as determined by the Investigator
- Is poorly compliant with prescribed self-monitoring of blood glucose, as determined by the Investigator
- Is currently taking or has taken sulfonylureas within the last 2 months
- Has a BMI greater than 40 kg/m2
- Has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months
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 Delivery DevicePaQ is a 3 day insulin delivery device. Utilizes U 100 rapid-acting insulin. Provides basal insulin at preset basal doses and bolus insulin (in 2 unit increments) with a push of a button. | Device | – |
Primary outcome
Change in glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) from baseline at Week 12
Time frame: 12 weeks
7 secondary outcomes
Change in A1C from baseline at Week 8
Time frame: 8 weeks
Change in fasting plasma glucose from baseline at end of study week 12
Time frame: 12 weeks
Change in 7-point blood glucose profiles and 1.5-2 hour postprandial blood glucose excursions (average and by meal) from baseline at week 12
Time frame: 12 weeks
Change in insulin dose (total, basal, and bolus) from Baseline at week 12
Time frame: 12 weeks
Change in body weight from baseline at Week 12
Time frame: 12 weeks
Occurrence of hypoglycemia, adverse events, and/or dermal irritation at PaQ application site
Time frame: Throughout the study
Change in measures of PROs from baseline at Week 12
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Terminated to allow continued optimization of the product.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Derived from this study: PubMed 29888811Mader JK, Lilly LC, Aberer F, Poettler T, Johns D, Trautmann M, Warner JL, Pieber TR. Improved glycaemic control and treatment satisfaction with a simple wearable 3-day insulin delivery device among people with Type 2 diabetes. Diabet Med. 2018 Oct;35(10):1448-1456. doi: 10.1111/dme.13708. Epub 2018 Jul 5.
- Individual participant dataSharing planned: Yes. No plan to share individual data sets, but will publish results.
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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?
An observational study of 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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 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 was stopped early (reason given: Terminated to allow continued optimization of the product.). Results are not available in the source record.
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?
Change in glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) from baseline at Week 12 (time frame: 12 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 NCT02158078, 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 26 Jul 2016.