Type 1 Diabetes MellitusNCT01578980
Outpatient Control-to-Range: System and Monitoring Testing
A study of Type 1 Diabetes Mellitus, run by University of Virginia at 2 sites in United States.
Trial summary
A single arm, single treatment study is proposed to assess the feasibility of the AP Platform (cell phone + Control to Range system) outside of a hospital based clinical research center. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Oral Glucose Tolerance Test (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 blood glucose (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
- 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
- Diabetic ketoacidosis within the 6 months prior to enrollment
- Severe hypoglycemia resulting in seizure, loss of consciousness, or 3rd party assistance in the 12 months prior to enrollment
- Subject reports that he/she has hypoglycemia unawareness with severe low blood sugars (e.g. <50 mg/dL without symptoms)
- 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 any cardiac disorder/arrhythmia, 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
Show all 36Show fewer
- Hematocrit <40% (males) and <35% (females)
- History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans
- Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the 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 current proliferative diabetic retinopathy, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment
- Active gastroparesis requiring current medical therapy
- If taking 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
- Active enrollment in another clinical trial
- Unwillingness to withhold dietary supplements two weeks prior to admission and for the duration of the study participation
- Use of anti-diabetic agents other than CSII including long-acting insulin, intermediate-acting insulin, metformin, sulfonylureas, meglitinides, thiazolidinediones, DPP-IV inhibitors, glucagon-like peptide 1 agonists, and alpha-glucosidase inhibitors
- Subjects with basal rates less than 0.05.
- RESTRICTIONS ON USE OF OTHER DRUGS OR TREATMENTS.
- Use of anti-diabetic agents other than CSII including long-acting insulin, intermediate-acting insulin, metformin, sulfonylureas, meglitinides, thiazolidinediones, DPP-IV inhibitors, glucagon-like peptide 1 agonists, and alpha-glucosidase inhibitors.
- Oral steroids are excluded
- Anticoagulant therapy other than aspirin is excluded
- Acetaminophen will not be allowed while the continuous glucose monitor is in use
- Dietary supplements will be withheld two weeks prior to admission and for the duration of study participation
- Medications that block symptoms of hypoglycemia, including but not limited to beta blockers
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia
Charlottesville, Virginia, 22904
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
A single arm, single treatment study is proposed to assess the feasibility of the AP Platform (cell phone + Control to Range system) outside of a hospital based clinical research center.
Read the detailed description
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). This inter-institutional and international research team has been on the forefront of CLC developments since the beginning of the Juvenile Diabetes Research Foundation (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 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 subjects will be responsible for operating the CTR system with nursing and technicians available for additional support. A study physician and senior engineer will be on call.
Five subjects each will be enrolled at University of Virginia and the University of California, Santa Barbara.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Outpatient Control-to-Range
- Keywords
- Artificial Pancreas, Type 1 Diabetes Mellitus, Control-to-Range, Closed-Loop Control, Continuous Glucose Monitor
- 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.
Outpatient Control-to-RangeDevice
Also called Ambulatory Artificial Pancreas
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.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Control-to-Range | Experimental | Outpatient Control-to-Range: Testing system connectivity Receives: Device: Outpatient Control-to-Range |
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 for the entire arm.
Measured: 42 hours
Secondary outcomes (1)
Frequency of Unplanned System Resets or Restarts
Frequency of unplanned system resets or restarts
Secondary endpoints include the estimation of the failure rates of system components, frequency analysis of lost or inaccurate CGM records, and percent time of active CTR. The failure/missing data records will be compared to failure/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 posted17 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, University of California, Santa Barbara
- Responsible party
- Principal investigator, Boris Kovatchev, PhD, University of Virginia
- Investigators
- Boris P. Kovatchev, Ph.D., Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578980
- Sponsor's protocol ID
- 16130
- Status last verified
- Aug 2014
- First submitted
- 13 Apr 2012
- Last updated
- 16 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kovatchev BP, Renard E, Cobelli C, Zisser HC, Keith-Hynes P, Anderson SM, Brown SA, Chernavvsky DR, Breton MD, Farret A, Pelletier MJ, Place J, Bruttomesso D, Del Favero S, Visentin R, Filippi A, Scotton R, Avogaro A, Doyle FJ 3rd. Feasibility of outpatient fully integrated closed-loop control: first studies of wearable artificial pancreas. Diabetes Care. 2013 Jul;36(7):1851-8. doi: 10.2337/dc12-1965.
PubMed 23801798
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Control-to-Range: System and Monitoring Testing
- ClinicalTrials.gov ID
- NCT01578980
- Acronym / sponsor ID
- 16130
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Artificial Pancreas, Type 1 Diabetes Mellitus, Control-to-Range, Closed-Loop Control, Continuous Glucose Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, University of California, Santa Barbara
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Apr 2012 (estimated)
- Results
- Posted 25 Aug 2014
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 the AP Platform (cell phone + Control to Range system) outside of a hospital based clinical research center.
Detailed description
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). This inter-institutional and international research team has been on the forefront of CLC developments since the beginning of the Juvenile Diabetes Research Foundation (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 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 subjects will be responsible for operating the CTR system with nursing and technicians available for additional support. A study physician and senior engineer will be on call.
Five subjects each will be enrolled at University of Virginia and the University of California, Santa Barbara.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatient Control-to-Range | Experimental | Device: Outpatient Control-to-RangeOutpatient Control-to-Range: Testing system connectivity |
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 blood glucose (BG) and active insulin.
- HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device
Key exclusion criteria (36 listed)
- Diabetic ketoacidosis within the 6 months prior to enrollment
- Severe hypoglycemia resulting in seizure, loss of consciousness, or 3rd party assistance in the 12 months prior to enrollment
- Subject reports that he/she has hypoglycemia unawareness with severe low blood sugars (e.g. <50 mg/dL without symptoms)
- Pregnancy; breast feeding, or intention of becoming pregnant
- Uncontrolled arterial hypertension (diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg)
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 |
|---|---|---|
| Outpatient Control-to-RangeAlso: Ambulatory Artificial PancreasSubjects 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. | Device | Outpatient Control-to-Range |
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 for the entire arm.
1 secondary outcome
Frequency of Unplanned System Resets or Restarts
Time frame: 42 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23801798Kovatchev BP, Renard E, Cobelli C, Zisser HC, Keith-Hynes P, Anderson SM, Brown SA, Chernavvsky DR, Breton MD, Farret A, Pelletier MJ, Place J, Bruttomesso D, Del Favero S, Visentin R, Filippi A, Scotton R, Avogaro A, Doyle FJ 3rd. Feasibility of outpatient fully integrated closed-loop control: first studies of wearable artificial pancreas. Diabetes Care. 2013 Jul;36(7):1851-8. doi: 10.2337/dc12-1965.
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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.
Boris P. Kovatchev, Ph.D. study chair
University of Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 1 Diabetes Mellitus, run by University of Virginia 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 19 inclusion and 36 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 16 Sep 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
On the ClinicalTrials.gov record for NCT01578980, 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 16 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.