Type 1 DiabetesNCT01773668
Feasibility Study - Integrated Sensor and Infusion Set. Trial III
A study testing Integrated sensor and infusion set. in people with Type 1 Diabetes and Type 2 Diabetes, run by Medtronic Diabetes R&D Denmark at 1 site in Sweden.
Trial summary
The purpose of this study is to collect performance data on the Integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Integrated sensor and infusion set.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2012to Jan 2013
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 21-70 years of age at time of screening (age criteria chosen in order to comply with other studies in the same field of research).
- Subject has a clinical diagnose of type 1 or type 2 diabetes, as determined by investigator.
- Subject has one or more established insulin carbohydrate ratio.
- Subject has one or more established insulin correction ratio.
- Subject is a high bolus user (>10 units/meal) for at least one meal a day.
- Subject is currently using a Medtronic insulin pump and has been so for a minimum of 3 months at time of enrollment.
Show all 10Show fewer
- Subject has been using insulin for more than one year.
- Subject is willing to wear two pumps, one sensor, one infusion set and one Integrated sensor and infusion set at one time (first night).
- Subject is willing to perform frequent SMBGs during Visits 3 and 4.
- Subject is in good general health without other acute or chronic illnesses.
Who cannot join
- Vulnerable population will not be included in the study
- Subject is pregnant as per urine test or lactating (if female), as self-declared by patient.
- Subject plans to become pregnant during the course of the study.
- Subject is unable to tolerate tape adhesive in the area of sensor placement.
- Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection).
- The subject has complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months.
- The subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening or which might confound the collection or interpretation of the study data.
- The subject has experienced two or more severe hypoglycemic events - seizures/coma requiring assistance in the past 6 months.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Skåne University Hospital, Department of Endokrinology
Malmö, 205 02
About this study
Official title: FEASIBILITY STUDY TO ASSESS PERFORMANCE OF THE INTEGRATED SENSOR AND INFUSION SET. WITH HIGH INSULIN NEED USERS (TRIAL III)
The purpose of this study is to collect performance data on the Integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. The hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy. This study focuses on high bolus patients. A high bolus is defined as 12 units or more.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Integrated sensor and infusion set.
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated sensor and infusion set.Device
| Study group | Role | What they receive |
|---|---|---|
| Integrated sensor and infusion set | Experimental | Not described Receives: Device: Integrated sensor and infusion set. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance data
The purpose of this study is to collect performance data on the integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities.
Measured: 4 months
Secondary outcomes (5)
Performance characteristics
Comparative analysis of performance characteristics of the sensors of the Integrated sensor and infusion set with the Enlite sensors will be performed. SMBG data will be used as reference.
Measured: 4 months
Functionality
Gluco-dynamic effect of insulin delivered via the integrated sensor and infusion set demonstrating that insulin was successfully delivered.
Measured: 4 months
Longevity
The longevity of the insulin delivery and glucose sensing functionalities will be assessed by comparing day 1 and day 3 of device wear
Measured: 4 months
skin impact
Skin condition after removal of the integrated sensor and infusion set will be evaluated and assessed by the clinical staff in the study survey (CRF)
Measured: 4 months
Physical duration
Investigational Center and subject's report on physical duration of the Integrated sensor and infusion set assessed in study survey (CFR)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Diabetes R&D Denmark
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Frid, MD, Principal investigator, Hospital of Malmo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773668
- Sponsor's protocol ID
- CEP 271
- Status last verified
- Jan 2013
- First submitted
- 31 Oct 2012
- Last updated
- 5 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEASIBILITY STUDY TO ASSESS PERFORMANCE OF THE INTEGRATED SENSOR AND INFUSION SET. WITH HIGH INSULIN NEED USERS (TRIAL III)
- ClinicalTrials.gov ID
- NCT01773668
- Acronym / sponsor ID
- CEP 271
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medtronic Diabetes R&D DenmarkIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Jan 2013 (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 collect performance data on the Integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. The hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy. This study focuses on high bolus patients. A high bolus is defined as 12 units or more.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated sensor and infusion set | Experimental | Device: Integrated sensor and infusion set. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is 21-70 years of age at time of screening (age criteria chosen in order to comply with other studies in the same field of research).
- Subject has a clinical diagnose of type 1 or type 2 diabetes, as determined by investigator.
- Subject has one or more established insulin carbohydrate ratio.
- Subject has one or more established insulin correction ratio.
- Subject is a high bolus user (>10 units/meal) for at least one meal a day.
Key exclusion criteria (8 listed)
- Vulnerable population will not be included in the study
- Subject is pregnant as per urine test or lactating (if female), as self-declared by patient.
- Subject plans to become pregnant during the course of the study.
- Subject is unable to tolerate tape adhesive in the area of sensor placement.
- Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection).
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 |
|---|---|---|
| Integrated sensor and infusion set. | Device | Integrated sensor and infusion set |
Primary outcome
Performance data
Time frame: 4 months
The purpose of this study is to collect performance data on the integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities.
5 secondary outcomes
Performance characteristics
Time frame: 4 months
Functionality
Time frame: 4 months
Longevity
Time frame: 4 months
skin impact
Time frame: 4 months
Physical duration
Time frame: 4 months
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 5 Feb 2013.
Related trials for Type 1 Diabetes
RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
RecruitingPhase 4
INfluenza VaccInation To Mitigate typE 1 Diabetes
Diabetes Mellitus, Type 1
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.
Anders Frid, MD principal investigator
Hospital of Malmo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated sensor and infusion set. in people with Type 1 Diabetes and Type 2 Diabetes, run by Medtronic Diabetes R&D Denmark at 1 site in Sweden.
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 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 5 Feb 2013. 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 Sweden. 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?
Performance data (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2013.