Type 1 DiabetesPhase 1NCT01919385
Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia
A Phase 1 study testing Predictive Low Glucose Minimizer in people with Type 1 Diabetes, run by Animas Corporation at 1 site in United States.
Trial summary
This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Predictive Low Glucose Minimizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2013
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21-65 years
- Type 1 diabetes mellitus for at least one year
- Currently using an insulin infusion pump for at least the past 6 months
Who cannot join
- Pregnancy
- History of Diabetic Ketoacidosis (DKA) in the past six months
- History of severe hypoglycemia (Seizure, unconsciousness) in the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Samsum Diabetes Reserach Inst.
Santa Barbara, California, 93105
About this study
Official title: Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting
This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.
Read the detailed description
This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
- Conditions
- Type 1 Diabetes
- Being tested
- Predictive Low Glucose Minimizer
- Keywords
- Type 1 diabetes, Insulin Pump
- 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.
Predictive Low Glucose MinimizerDevice
Also called type 1 diabetes
This study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetes | Experimental | Predictive Low Glucose Minimizer (PLGM) System Receives: Device: Predictive Low Glucose Minimizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting
Evaluating the ability of the system to predict a fall or rise in glucose values below or above a low glucose threshold, and take the corresponding appropriate action of reducing or suspending insulin delivery in order to keep the subject's glucose above this threshold, or resuming insulin delivery at the current basal rate upon the increase of glucose above this threshold.
Ability of the system to issue timely and accurate warnings.
Measured: 1 week after subject is enrolled in the study
Secondary outcomes (1)
Capturing the number of Adverse Events as a measure of assessing subject safety
Understand the System's ability to safely keep the subject glucose levels within designated threshold. The subject and the device will be continuously monitored by the Principle Investigator and Algorithm Engineer to ensure proper function of the device and subject safety. All Adverse Events will be captured on the CRF.
Measured: 1 week after subject is enrolled in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
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 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Animas Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Zisser, MD, Principal investigator, Samsum Diabetes Reserach Inst.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919385
- Sponsor's protocol ID
- 3108873,
- Status last verified
- Sep 2013
- First submitted
- 28 Jun 2013
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Finan DA, Dassau E, Breton MD, Patek SD, McCann TW Jr, Kovatchev BP, Doyle FJ 3rd, Levy BL, Venugopalan R. Sensitivity of the Predictive Hypoglycemia Minimizer System to the Algorithm Aggressiveness Factor. J Diabetes Sci Technol. 2015 Jun 30;10(1):104-10. doi: 10.1177/1932296815593292.
PubMed 26134834
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting
- ClinicalTrials.gov ID
- NCT01919385
- Acronym / sponsor ID
- 3108873,
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Insulin Pump
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Animas CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 9 Aug 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.
This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.
Detailed description
This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetes | Experimental | Device: Predictive Low Glucose MinimizerPredictive Low Glucose Minimizer (PLGM) System |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21-65 years
- Type 1 diabetes mellitus for at least one year
- Currently using an insulin infusion pump for at least the past 6 months
Key exclusion criteria (3 listed)
- Pregnancy
- History of Diabetic Ketoacidosis (DKA) in the past six months
- History of severe hypoglycemia (Seizure, unconsciousness) in 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 |
|---|---|---|
| Predictive Low Glucose MinimizerAlso: type 1 diabetesThis study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results. | Device | type 1 diabetes |
Primary outcome
Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting
Time frame: 1 week after subject is enrolled in the study
Evaluating the ability of the system to predict a fall or rise in glucose values below or above a low glucose threshold, and take the corresponding appropriate action of reducing or suspending insulin delivery in order to keep the subject's glucose above this threshold, or resuming insulin delivery at the current basal rate upon the increase of glucose above this threshold. Ability of the system to issue timely and accurate warnings.
1 secondary outcome
Capturing the number of Adverse Events as a measure of assessing subject safety
Time frame: 1 week after subject is enrolled in the study
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 19 Sep 2013.
- Derived from this study: PubMed 26134834Finan DA, Dassau E, Breton MD, Patek SD, McCann TW Jr, Kovatchev BP, Doyle FJ 3rd, Levy BL, Venugopalan R. Sensitivity of the Predictive Hypoglycemia Minimizer System to the Algorithm Aggressiveness Factor. J Diabetes Sci Technol. 2015 Jun 30;10(1):104-10. doi: 10.1177/1932296815593292.
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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.
Howard Zisser, MD principal investigator
Samsum Diabetes Reserach Inst.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Predictive Low Glucose Minimizer in people with Type 1 Diabetes, run by Animas Corporation 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 3 inclusion and 3 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 19 Sep 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 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting (time frame: 1 week after subject is enrolled in the study). 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 NCT01919385, 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 19 Sep 2013.