Type 1 Diabetes MellitusNCT01470807
Pilot Study 1 of Outpatient Control-to-Range - System and Monitoring Testing
A study testing portable artificial pancreas system with CTR algorithms in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in Italy.
Trial summary
A single arm, single treatment study is proposed to assess the feasibility of a portable artificial pancreas system outside of a hospital based clinical research center. Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous insulin infusion pump and a continuous glucose monitor for… 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?
- portable artificial pancreas system with CTR algorithms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be aged between 21 (inclusive) and 65 years old. The age of 21 has been chosen because this trial is supported by a US Foundation.
- Patient must have been clinically diagnosed with Type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met:
- Criteria for documented hyperglycemia (at least 1 must be met):
- Fasting glucose ≥126 mg/dL - confirmed
- Two-hour OGTT glucose ≥200 mg/dL - confirmed
- HbA1c ≥6.5% documented - confirmed
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- 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 (1 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 a carbohydrate [CHO] / insulin ratio for insulin bolus adjustments in order to keep blood glucose in a predefined range
- Patient HbA1c is between 6.0% and 9% as measured with DCA2000 or equivalent device
- Patient must demonstrate proper mental status and cognition for the study
- Patient must be willing to avoid consumption of acetaminophen-containing products during the study interventions involving DexCom use
- Patient must be affiliated or beneficiary of a social medical insurance
- Patient has signed informed consent form prior to study entry
Who cannot join
- Diabetic ketoacidosis within the 6 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy, breast feeding, or intention of becoming pregnant
- Uncontrolled arterial hypertension (diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg)
- Conditions which may increase the risk of hypoglycemia such as uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, or positive stress test or catheterization with coronary blockages >50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation
- History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans
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- Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the DexCom CGM (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants)
- Anticoagulant therapy other than aspirin
- Oral steroids
- Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admissions.
- Psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment)
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Known current or recent alcohol or drug abuse
- Medical conditions that would make operating a CGM, cell phone, or insulin pump difficult (e.g. blindness, severe arthritis, immobility)
- Any skin condition that prevents sensor or pump placement on the abdomen or arm (e.g. bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
- Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase ≥three times the upper reference limit
- Impaired renal function measured as creatinine >1.2 times above the upper limit of normal
- Uncontrolled microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment
- Active gastroparesis requiring current medical therapy
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
- Uncontrolled thyroid disease
- Known bleeding diathesis or dyscrasia
- Known allergy to medical adhesives, components of the insulin pump insertion set or continuous glucose monitor sensor
- Unwillingness to withhold dietary supplements two weeks prior to admission and for the duration of the study participation.
- Unwillingness to withhold pramlintide, liraglutide and exenatide for the duration of the study intervention.
- Patient is actively enrolled in another clinical trial or was part of study within 30 days or whose annual study income is over 4 500€
- Persons deprived of freedom, adults protected by law or vulnerable persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of a Portable Artificial Pancreas System in Type 1 Diabetes
A single arm, single treatment study is proposed to assess the feasibility of a portable artificial pancreas system outside of a hospital based clinical research center.
Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions (hotel).
Read the detailed description
Automated closed-loop control (CLC), known as "artificial pancreas" (AP) can have tremendous impact on the health and lives of people with type 1 diabetes (T1D). Our 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, we have conducted three closed-loop control clinical trials (totaling 60 subjects with T1D), 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. Our 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 an automated Range Correction Module (RCM). 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 RCM will be responsible for the optimal regulation of postprandial hyperglycemic excursions through correction boluses.
The first phase to address our overall objective is a pilot study that will test the ability of a cell-phone-based system to (1) run CTR in an outpatient setting, and (2) be remotely monitored. Specifically, this pilot study entails a hybrid hotel/hospital design targeting adults with T1D that are experienced insulin pump users. Subjects will spend one night in a local hotel, during which the phone-based system will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur. Subjects will spend the following day in the hospital, where CTR will be activated, and challenged with meals and a CGM sensor replacement . Subjects will then spend a second night in the hotel for continued evaluation of remote system monitoring, along with outpatient testing of the CTR system run on the phone-based system. This series of admissions will address the first major hurdles that need to be overcome for home deployment of a closed loop CTR system:
Specific Aim 1: The phone-based CTR system can be remotely monitored by nurses/physicians/technicians to confirm appropriate functioning outside of the hospital setting.
Specific Aim 2: The CTR can be deployed outside of the hospital setting.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- portable artificial pancreas system with CTR algorithms
- Keywords
- Artificial Pancreas, Insulin Pump, Continuous Glucose Monitor, Closed Loop
- 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.
portable artificial pancreas system with CTR algorithmsDevice
The investigators will test the new portable CTR system in CRC conditions for 10h followed by 18h of CTR in a hotel.
| Study group | Role | What they receive |
|---|---|---|
| portable artificial pancreas system with CTR algorithms | Experimental | This is the only arm of the study and concerns all patients. Receives: Device: portable artificial pancreas system with CTR algorithms |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimation of the failure rates of system components
the investigators will estimate the frequency of failures (#failures/day) of each following system components: CGM communication, pump communication, insulin dose computation, user interface.
Measured: length of admission (hour 42)
Secondary outcomes (2)
frequency analysis of lost or inaccurate CGM records
number of CGM data point not received by the device divided by the total number of possible data points to be received.
Measured: length of admission (42 hours)
percent time of active CTR
number of minutes the Control-To-Range system was functioning properly (computation of insulin infusion, and insulin actually delivered) divided by the maximum number of minutes the CTR system should have been active (as per protocol)
Measured: length of admission (42h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 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.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Montpellier, University of Padova, University of California, Santa Barbara
- Responsible party
- Sponsor
- Investigators
- Claudio Cobelli, Ph.D., Principal investigator, University of PadovaBoris Kovatchev, Ph.D., Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470807
- Sponsor's protocol ID
- 0054961
- Status last verified
- Nov 2012
- First submitted
- 9 Nov 2011
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Portable Artificial Pancreas System in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01470807
- Acronym / sponsor ID
- 0054961
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Artificial Pancreas, Insulin Pump, Continuous Glucose Monitor, Closed Loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University Hospital, Montpellier, University of Padova, University of California, Santa Barbara
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Nov 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.
A single arm, single treatment study is proposed to assess the feasibility of a portable artificial pancreas system outside of a hospital based clinical research center.
Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions (hotel).
Detailed description
Automated closed-loop control (CLC), known as "artificial pancreas" (AP) can have tremendous impact on the health and lives of people with type 1 diabetes (T1D). Our 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, we have conducted three closed-loop control clinical trials (totaling 60 subjects with T1D), 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. Our 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 an automated Range Correction Module (RCM). 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 RCM will be responsible for the optimal regulation of postprandial hyperglycemic excursions through correction boluses.
The first phase to address our overall objective is a pilot study that will test the ability of a cell-phone-based system to (1) run CTR in an outpatient setting, and (2) be remotely monitored. Specifically, this pilot study entails a hybrid hotel/hospital design targeting adults with T1D that are experienced insulin pump users. Subjects will spend one night in a local hotel, during which the phone-based system will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur. Subjects will spend the following day in the hospital, where CTR will be activated, and challenged with meals and a CGM sensor replacement . Subjects will then spend a second night in the hotel for continued evaluation of remote system monitoring, along with outpatient testing of the CTR system run on the phone-based system. This series of admissions will address the first major hurdles that need to be overcome for home deployment of a closed loop CTR system:
Specific Aim 1: The phone-based CTR system can be remotely monitored by nurses/physicians/technicians to confirm appropriate functioning outside of the hospital setting.
Specific Aim 2: The CTR can be deployed outside of the hospital setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| portable artificial pancreas system with CTR algorithms | Experimental | Device: portable artificial pancreas system with CTR algorithmsThis is the only arm of the study and concerns all patients. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient must be aged between 21 (inclusive) and 65 years old. The age of 21 has been chosen because this trial is supported by a US Foundation.
- Patient must have been clinically diagnosed with Type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met:
- Use of an insulin pump to treat his/her diabetes for at least 1 year
- Actively using a carbohydrate [CHO] / insulin ratio for insulin bolus adjustments in order to keep blood glucose in a predefined range
- Patient HbA1c is between 6.0% and 9% as measured with DCA2000 or equivalent device
Key exclusion criteria (27 listed)
- Diabetic ketoacidosis within the 6 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy, breast feeding, or intention of becoming pregnant
- Uncontrolled arterial hypertension (diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg)
- Conditions which may increase the risk of hypoglycemia such as uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, or positive stress test or catheterization with coronary blockages >50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation
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 |
|---|---|---|
| portable artificial pancreas system with CTR algorithmsThe investigators will test the new portable CTR system in CRC conditions for 10h followed by 18h of CTR in a hotel. | Device | portable artificial pancreas system with CTR algorithms |
Primary outcome
estimation of the failure rates of system components
Time frame: length of admission (hour 42)
the investigators will estimate the frequency of failures (#failures/day) of each following system components: CGM communication, pump communication, insulin dose computation, user interface.
2 secondary outcomes
frequency analysis of lost or inaccurate CGM records
Time frame: length of admission (42 hours)
percent time of active CTR
Time frame: length of admission (42h)
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 29 Nov 2012.
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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.
Claudio Cobelli, Ph.D. principal investigator
University of Padova
Boris Kovatchev, Ph.D. study chair
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing portable artificial pancreas system with CTR algorithms in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in Italy.
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 27 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 29 Nov 2012. 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 Italy. 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?
estimation of the failure rates of system components (time frame: length of admission (hour 42)). 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 29 Nov 2012; AzTrials last refreshed its copy on 6 Nov 2026.