Type 1 Diabetes MellitusNCT01401751
Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting
A study testing Hypoglycemia-Hyperglycemia Minimizer System in people with Type 1 Diabetes Mellitus, run by Animas Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) setting. 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 Mellitus
- What is being tested?
- Hypoglycemia-Hyperglycemia Minimizer System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2011to 1 Dec 2011
- 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 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
- 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
- Other Inclusion/Exclusion criteria apply.
- Please contact clinical study site for complete details.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
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 24 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
Total subject participation approximately 1 week for screening to completion. This includes approximately 24 hours usage of the investigation device in the clinical research center under close medical supervision.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Hypoglycemia-Hyperglycemia Minimizer System
- Keywords
- Type 1 Diabetes Mellitus, Artificial Pancreas
- 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.
Hypoglycemia-Hyperglycemia Minimizer SystemDevice
Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | non-randomized, uncontrolled, feasibility study Receives: Device: Hypoglycemia-Hyperglycemia Minimizer System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
Measuring the response of the investigational device, including insulin delivery dosing changes in response to glucose changes. Also, the ability of the system to mitigate Hypoglycemia.
Measured: End of Study - in approximately 5 months from first subject enrolled
Secondary outcomes (1)
Safety Evaluation
Measuring the following:
- the number and type of adverse events, including Adverse device effects, Serious Adverse Events, Unanticipated Adverse Device Effects, device malfunctions
- Resulting glucose data from 24 hour clinical research center visit
Measured: End of Study - in approximately 5 months from first subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study start1 Jul 2011
- Primary completion1 Nov 2011
- Study completion1 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Animas Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Zisser, MD, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401751
- Sponsor's protocol ID
- 3076823
- Status last verified
- Jan 2025
- First submitted
- 21 Jul 2011
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. 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 And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting
- ClinicalTrials.gov ID
- NCT01401751
- Acronym / sponsor ID
- 3076823
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, Artificial Pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Animas CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 1 Nov 2011 (actual)
- Study completion
- 1 Dec 2011 (actual)
- First posted
- 25 Jul 2011 (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 performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
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 24 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
Total subject participation approximately 1 week for screening to completion. This includes approximately 24 hours usage of the investigation device in the clinical research center under close medical supervision.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Hypoglycemia-Hyperglycemia Minimizer Systemnon-randomized, uncontrolled, feasibility study |
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
- Using an insulin infusion pump for at least the past 6 months
Key exclusion criteria (5 listed)
- Pregnancy
- History of diabetic ketoacidosis (DKA) in the past six months
- History of severe hypoglycemia (seizure, unconsciousness) in the past 6 months
- Other Inclusion/Exclusion criteria apply.
- Please contact clinical study site for complete details.
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 |
|---|---|---|
| Hypoglycemia-Hyperglycemia Minimizer SystemHypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm | Device | Single Arm |
Primary outcome
To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
Time frame: End of Study - in approximately 5 months from first subject enrolled
Measuring the response of the investigational device, including insulin delivery dosing changes in response to glucose changes. Also, the ability of the system to mitigate Hypoglycemia.
1 secondary outcome
Safety Evaluation
Time frame: End of Study - in approximately 5 months from first subject enrolled
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 3 Feb 2025.
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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
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoglycemia-Hyperglycemia Minimizer System in people with Type 1 Diabetes Mellitus, 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 5 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 3 Feb 2025. 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.
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?
To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting. (time frame: End of Study - in approximately 5 months from first subject enrolled). 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 3 Feb 2025; AzTrials last refreshed its copy on 1 Nov 2026.