Diabetes MellitusPhase 1NCT02877771
Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study
A Phase 1 study testing t:slim insulin pump with predictive low glucose suspend in people with Diabetes Mellitus and Type 1 Diabetes, run by Tandem Diabetes Care, Inc. at 2 sites in United States.
Trial summary
The goal of this study is to assess the functionality of an integrated predictive low glucose suspend system designed to minimize the incidence and duration of hypoglycemia by suspending insulin delivery if hypoglycemia is projected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1 Diabetes, Insulin Pump
- What is being tested?
- t:slim insulin pump with predictive low glucose suspend
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2016to Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 1 diabetes requiring insulin therapy for at least 12 months
- Insulin pump therapy for at least 6 months
- Age ≥18.0 years
- Subject demonstrates stable insulin regimen including basal rates, insulin sensitivity factor and insulin:carbohydrate ratio for at least 3 months
Who cannot join
- Pregnant (female subjects must have negative urine or serum pregnancy screening test)
- Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
- Diabetic ketoacidosis in the month prior to enrollment
- A current condition that would prevent the use of a CGM sensor or insulin pump, or in the judgment of the investigator is a contraindication to study participation
- Use of acetaminophen during study participation
- Current use of any medication intended to lower glucose other than insulin including naturaceuticals, oral or non-insulin injectable medications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Stanford University
Palo Alto, California, 94304
About this study
The goal of this study is to assess the functionality of an integrated predictive low glucose suspend system designed to minimize the incidence and duration of hypoglycemia by suspending insulin delivery if hypoglycemia is projected.
Read the detailed description
This protocol is designed to test the functionality of a predictive low glucose suspend system under supervised conditions where basal insulin rates are manually increased until a system generated suspension occurs. The study will collect data that will be used for planning a pivotal study, and the study data are intended to be used to support a Premarket Approval (PMA) application.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Insulin Pump
- Being tested
- t:slim insulin pump with predictive low glucose suspend
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
t:slim insulin pump with predictive low glucose suspendDevice
To assess the functionality of a predictive low glucose suspend (PLGS) system that uses Continuous Glucose Monitoring (CGM) values to suspend basal insulin delivery when hypoglycemia is predicted as well as resume basal insulin delivery once Continuous Glucose Monitoring (CGM) values begin to increase.
| Study group | Role | What they receive |
|---|---|---|
| t:slim insulin pump with predictive low glucose suspend | Experimental | To assess the functionality of a predictive low glucose suspend (PLGS) system that uses CGM values to suspend basal insulin delivery when hypoglycemia is predicted as well as resume basal insulin delivery once Continuous Glucose Monitoring (CGM) values begin to increase. Receives: Device: t:slim insulin pump with predictive low glucose suspend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suspension of Insulin Delivery
To test functionality of the system
Measured: 8 hours between 9pm and 5am
Restoration of insulin delivery
To test functionality of the system
Measured: 8 hours between 9pm and 5am
Agreement between algorithm-recommended pump action
To test functionality of the system
Measured: 8 hours between 9pm and 5am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tandem Diabetes Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877771
- Sponsor's protocol ID
- 010300
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study
- ClinicalTrials.gov ID
- NCT02877771
- Acronym / sponsor ID
- 010300
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Insulin Pump
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tandem Diabetes Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Study start
- Aug 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Aug 2016 (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 goal of this study is to assess the functionality of an integrated predictive low glucose suspend system designed to minimize the incidence and duration of hypoglycemia by suspending insulin delivery if hypoglycemia is projected.
Detailed description
This protocol is designed to test the functionality of a predictive low glucose suspend system under supervised conditions where basal insulin rates are manually increased until a system generated suspension occurs. The study will collect data that will be used for planning a pivotal study, and the study data are intended to be used to support a Premarket Approval (PMA) application.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| t:slim insulin pump with predictive low glucose suspend | Experimental | Device: t:slim insulin pump with predictive low glucose suspendTo assess the functionality of a predictive low glucose suspend (PLGS) system that uses CGM values to suspend basal insulin delivery when hypoglycemia is predicted as well as resume basal insulin delivery once Continuous Glucose Monitoring (CGM) values begin to increase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of type 1 diabetes requiring insulin therapy for at least 12 months
- Insulin pump therapy for at least 6 months
- Age ≥18.0 years
- Subject demonstrates stable insulin regimen including basal rates, insulin sensitivity factor and insulin:carbohydrate ratio for at least 3 months
Key exclusion criteria (6 listed)
- Pregnant (female subjects must have negative urine or serum pregnancy screening test)
- Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
- Diabetic ketoacidosis in the month prior to enrollment
- A current condition that would prevent the use of a CGM sensor or insulin pump, or in the judgment of the investigator is a contraindication to study participation
- Use of acetaminophen during study participation
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 |
|---|---|---|
| t:slim insulin pump with predictive low glucose suspendTo assess the functionality of a predictive low glucose suspend (PLGS) system that uses Continuous Glucose Monitoring (CGM) values to suspend basal insulin delivery when hypoglycemia is predicted as well as resume basal insulin delivery once Continuous Glucose Monitoring (CGM) values begin to increase. | Device | t:slim insulin pump with predictive low glucose suspend |
Primary outcome
Suspension of Insulin Delivery
Time frame: 8 hours between 9pm and 5am
To test functionality of the system
Restoration of insulin delivery
Time frame: 8 hours between 9pm and 5am
To test functionality of the system
Agreement between algorithm-recommended pump action
Time frame: 8 hours between 9pm and 5am
To test functionality of the system
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 1 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing t:slim insulin pump with predictive low glucose suspend in people with Diabetes Mellitus and Type 1 Diabetes, run by Tandem Diabetes Care, Inc. at 2 sites 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 4 inclusion and 6 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 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Suspension of Insulin Delivery (time frame: 8 hours between 9pm and 5am). The study lists 3 primary outcomes in all. 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 1 Sep 2016.