Type 1 Diabetes MellitusNCT01697150
Outpatient Control-to-Range: System and Monitoring Testing
A study testing DiAs Diabetes Assistant Wearable Artificial Pancreas Platform in people with Type 1 Diabetes Mellitus, run by Sansum Diabetes Research Institute at 1 site in United States.
Trial summary
Automated closed-loop control (CLC) of blood glucose, known as "artificial pancreas" (AP) can have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- DiAs Diabetes Assistant Wearable Artificial Pancreas Platform
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥21 and <65 years old
- Clinical diagnosis of type 1 diabetes mellitus:
- Criteria for documented hyperglycemia (at least 1 criterion must be met):
- Fasting glucose ≥126 mg/dL - confirmed
- Two-hour OGTT glucose ≥200 mg/dL - confirmed
- HbA1c ≥6.5% documented by history - confirmed
Show all 19Show fewer
- Random glucose ≥200 mg/dL with symptoms
- No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
- Criteria for requiring insulin at diagnosis (at least 1 criterion must be met):
- Participant required insulin at diagnosis and continually thereafter
- Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually
- Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually
- Use of an insulin pump to treat his/her diabetes for at least 1 year
- Actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active insulin.
- HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device
- Not currently known to be pregnant, breast feeding, or intending to become pregnant (females)
- Demonstration of proper mental status and cognition for the study
- Willingness to avoid consumption of acetaminophen-containing products during the study interventions involving DexCom use
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study
Who cannot join
- ≥21 and <65 years old
- Clinical diagnosis of type 1 diabetes mellitus:
- Criteria for documented hyperglycemia (at least 1 criterion must be met):
- Fasting glucose ≥126 mg/dL - confirmed
- Two-hour OGTT glucose ≥200 mg/dL - confirmed
- HbA1c ≥6.5% documented by history - confirmed
Show all 19Show fewer
- Random glucose ≥200 mg/dL with symptoms
- No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
- Criteria for requiring insulin at diagnosis (at least 1 criterion must be met):
- Participant required insulin at diagnosis and continually thereafter
- Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually
- Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually
- Use of an insulin pump to treat his/her diabetes for at least 1 year
- Actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active insulin.
- HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device
- Not currently known to be pregnant, breast feeding, or intending to become pregnant (females)
- Demonstration of proper mental status and cognition for the study
- Willingness to avoid consumption of acetaminophen-containing products during the study interventions involving DexCom use
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Systems Approach to Closed-Loop Control of Type 1 Diabetes at Home
Automated closed-loop control (CLC) of blood glucose, known as "artificial pancreas" (AP) can have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). The investigators inter-institutional and international research team has been on the forefront of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006. Thus far, the investigators have conducted three closed-loop control clinical trials (totaling 60 subjects with T1DM), which demonstrated significantly more time in an acceptable "target" blood glucose range during CLC, and significantly fewer hypoglycemic events during CLC compared to open loop. The investigators overall objective is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and a Hypoglycemia Mitigation Module (HMM). The SSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia and will also monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations or loss of sensitivity. The HMM will be responsible for the optimal regulation of postprandial hyperglycemic excursions through correction boluses.
This study will test the ability of AP Platform to (1) run CTR in an outpatient setting, and (2) be remotely monitored. Specifically, this study involves studying adults with T1DM who are experienced insulin pump users. Subjects will spend two nights (-42 hours) in a local hotel, during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur. During the study, study subject will be responsible for. operating the CTR system with nursing and technicians available
Read the detailed description
I.A. PURPOSE/OBJECTIVES
- Primary objective The purpose of this pilot study is to test a closed-loop Control-to-Range (CTR) system in a semi-controlled environment and especially to evaluate if the system can accurately collect data coming from patient inputs, insulin pump, and continuous glucose monitoring (CGM) device with more than 80% of time of use.
- Secondary objectives
This pilot study will use a Artificial Pancreas Platform (AP Platform) cell phone/phone-based system to test an outpatient controller and remote monitoring as follows:
- test that the CTR system can be remotely monitored by nurses/physicians/ technicians to confirm appropriate functioning outside of the hospital setting
- test that the CTR system can be deployed, with appropriate subject response, outside of the hospital setting
I.B. STUDY DESIGN
This study is an early feasibility pilot trial with the principal goal is to validate an initial outpatient ready CTR system and its remote-monitoring capability. Therefore, this is an unblinded pilot study and no control group will be used.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- DiAs Diabetes Assistant Wearable Artificial Pancreas Platform
- Keywords
- Type 1 diabetes mellitus, closed loop 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.
DiAs Diabetes Assistant Wearable Artificial Pancreas PlatformDevice
Subjects will spend two nights in a non hospital setting while the Artificial Pancreas Device System is remotely monitored from an adjacent room. Artificial Pancreas Device System is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings.
| Study group | Role | What they receive |
|---|---|---|
| Control to Range Testing | Experimental | Subjects will spend two nights in a non hospital setting while the DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is remotely monitored from an adjacent room. DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings. Receives: Device: DiAs Diabetes Assistant Wearable Artificial Pancreas Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent time of active CTR
The main endpoint will be the percent time with all expected data from CGM, pump and patient manual inputs that should be available on Artificial Pancreas platform and monitoring stations. To be considered as successful, this percent time will have to reach more than 80% of total time of investigation.
Measured: 42 hours
Secondary outcomes (3)
Frequency analysis of failed data caused by system components
The failed data records will be compared to failure/missing data records from our past in-clinic studies
Measured: 42 hours
Frequency of inaccurate data caused by system components
Continuous glucose sensor data will be compared with Hemocue data for accuracy.
Measured: 42 hours
Frequency analysis of lost data caused by system components
The failure/missing data records will be compared to missing data records from our past in-clinic studies
Measured: 42 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2015
- Study completionDec 2015
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Santa Barbara, University of Virginia
- Responsible party
- Principal investigator, Jordan Pinsker, Sansum Diabetes Research Institute
- Investigators
- Howard Zisser, MD, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697150
- Sponsor's protocol ID
- JDRF 22-2011-649 SB
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2012
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Approach to Closed-Loop Control of Type 1 Diabetes at Home
- ClinicalTrials.gov ID
- NCT01697150
- Acronym / sponsor ID
- JDRF 22-2011-649 SB
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, closed loop artificial pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- University of California, Santa Barbara, University of Virginia
- Study start
- Apr 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Oct 2012 (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.
Automated closed-loop control (CLC) of blood glucose, known as "artificial pancreas" (AP) can have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). The investigators inter-institutional and international research team has been on the forefront of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006. Thus far, the investigators have conducted three closed-loop control clinical trials (totaling 60 subjects with T1DM), which demonstrated significantly more time in an acceptable "target" blood glucose range during CLC, and significantly fewer hypoglycemic events during CLC compared to open loop. The investigators overall objective is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and a Hypoglycemia Mitigation Module (HMM). The SSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia and will also monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations or loss of sensitivity. The HMM will be responsible for the optimal regulation of postprandial hyperglycemic excursions through correction boluses.
This study will test the ability of AP Platform to (1) run CTR in an outpatient setting, and (2) be remotely monitored. Specifically, this study involves studying adults with T1DM who are experienced insulin pump users. Subjects will spend two nights (-42 hours) in a local hotel, during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur. During the study, study subject will be responsible for. operating the CTR system with nursing and technicians available
Detailed description
I.A. PURPOSE/OBJECTIVES
- Primary objective The purpose of this pilot study is to test a closed-loop Control-to-Range (CTR) system in a semi-controlled environment and especially to evaluate if the system can accurately collect data coming from patient inputs, insulin pump, and continuous glucose monitoring (CGM) device with more than 80% of time of use.
- Secondary objectives
This pilot study will use a Artificial Pancreas Platform (AP Platform) cell phone/phone-based system to test an outpatient controller and remote monitoring as follows:
- test that the CTR system can be remotely monitored by nurses/physicians/ technicians to confirm appropriate functioning outside of the hospital setting
- test that the CTR system can be deployed, with appropriate subject response, outside of the hospital setting
I.B. STUDY DESIGN
This study is an early feasibility pilot trial with the principal goal is to validate an initial outpatient ready CTR system and its remote-monitoring capability. Therefore, this is an unblinded pilot study and no control group will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control to Range Testing | Experimental | Device: DiAs Diabetes Assistant Wearable Artificial Pancreas PlatformSubjects will spend two nights in a non hospital setting while the DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is remotely monitored from an adjacent room. DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- ≥21 and <65 years old
- Clinical diagnosis of type 1 diabetes mellitus:
- Use of an insulin pump to treat his/her diabetes for at least 1 year
- Actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active insulin.
- HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device
Key exclusion criteria (19 listed)
- ≥21 and <65 years old
- Clinical diagnosis of type 1 diabetes mellitus:
- Use of an insulin pump to treat his/her diabetes for at least 1 year
- Actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active insulin.
- HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device
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 |
|---|---|---|
| DiAs Diabetes Assistant Wearable Artificial Pancreas PlatformSubjects will spend two nights in a non hospital setting while the Artificial Pancreas Device System is remotely monitored from an adjacent room. Artificial Pancreas Device System is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings. | Device | Control to Range Testing |
Primary outcome
Percent time of active CTR
Time frame: 42 hours
The main endpoint will be the percent time with all expected data from CGM, pump and patient manual inputs that should be available on Artificial Pancreas platform and monitoring stations. To be considered as successful, this percent time will have to reach more than 80% of total time of investigation.
3 secondary outcomes
Frequency analysis of failed data caused by system components
Time frame: 42 hours
Frequency of inaccurate data caused by system components
Time frame: 42 hours
Frequency analysis of lost data caused by system components
Time frame: 42 hours
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 21 Apr 2016.
- http://www.sansum.org/research-trials/current-trials/Link provided by the sponsor.
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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 DiAs Diabetes Assistant Wearable Artificial Pancreas Platform in people with Type 1 Diabetes Mellitus, run by Sansum Diabetes Research Institute 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 19 inclusion and 19 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 21 Apr 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 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?
Percent time of active CTR (time frame: 42 hours). 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 21 Apr 2016.