Diabetes Mellitus, Type 1NCT01714505
Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy
A study testing Diabetes Assistant (DiAs) in people with Diabetes Mellitus, Type 1, run by University of Virginia at 2 sites in United States.
Trial summary
An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a hospital based clinical research center. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Diabetes Assistant (DiAs)
- 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
- Oct 2012to Jan 2013
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥21 and <65 years old.
- Clinical diagnosis of type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met.
- o Criteria for documented hyperglycemia (at least 1 must be met): i. Fasting glucose ≥126 mg/dL - confirmed ii. Two-hour Oral Glucose Tolerance Test (OGTT) glucose ≥200 mg/dL - confirmed iii. HbA1c ≥6.5% documented - confirmed iv. Random glucose ≥200 mg/dL with symptoms v. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
- o Criteria for requiring insulin at diagnosis (1 must be met): i. Participant required insulin at diagnosis and continually thereafter ii. 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 iii. 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.
- Familiarity with a bolus calculator with the current insulin pump with pre-defined parameters for carbohydrate (CHO) ratio, insulin sensitivity factor (ISF), target glucose and active insulin.
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- HbA1c <9% 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 CGM 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
- Severe hypoglycemia resulting in seizure, loss of consciousness, or diabetic ketoacidosis within the 12 months prior to enrollment.
- Pregnancy; breast feeding, or intention of becoming pregnant.
- Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg).
- Conditions which may increase the risks associated with possible hypoglycemia, such as any active 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.
- Self-reported hypoglycemia unawareness.
- 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 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, the DiAs 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).
- In adherence with the One Touch Ultra 2 User Guide, subjects with hematocrit levels less than 30% and above 55% will be excluded.
- 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, such as current proliferative diabetic retinopathy or macular edema, 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.
- Active enrollment in another clinical trial.
- Use of anti-diabetic agents other than continuous subcutaneous insulin infusion (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 0.01U/hr.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia
Charlottesville, Virginia, 22908
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a hospital based clinical research center. The principal goal is to validate a smart phone-based control-to-range (CTR) system for ambulatory use and to estimate the effect of CTR vs. sensor-augmented pump therapy, thereby providing justification for further larger home-based trials of CTR.
Read the detailed description
The overall objective of this project is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system for optimal blood glucose (BG) regulation in people with type 1 diabetes. The CTR system is comprised of two algorithmic layers: a Safety Supervision Module (SSM) and Insulin on Board Tracking and Safety Module (ITSM), and an automated Range Correction Module (RCM). Both modules will receive continuous glucose monitoring (CGM) and insulin delivery data. The SSM and ITSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia. The RCM will be responsible for optimizing BG control and mitigating postprandial hyperglycemic excursions through series of insulin boluses. To run CTR, we will use our wearable artificial pancreas platform, known as DiAs (Diabetes Assistant), which consists of a smart phone running CTR and connected to standard insulin delivery and CGM devices.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Diabetes Assistant (DiAs)
- Keywords
- Diabetes Mellitus, Type 1, Continuous Glucose Monitor, Artificial Pancreas, Insulin Pump, Closed Loop control, Open Loop treatment
- 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.
Diabetes Assistant (DiAs)Device
A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Involving Automated CTR | Experimental | Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system. Receives: Device: Diabetes Assistant (DiAs) |
| CGM-Augmented Insulin Pump Treatment | No intervention | Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, Low Blood Glucose Index (LBGI)
The LBGI reflects the frequency and extent of hypoglycemic episodes and presents the results in "risk space." Thus the LBGI is a weighted average of the number of hypoglycemic readings, with progressively increasing weights as BG levels go down. The increase of the weights follows a risk function; thus the LBGI has been associated with risk for hypoglycemia and prediction of severe hypoglycemic episodes.
LBGI < 2.5 is associated with low risk of hypoglycemia, 2.5 < LBGI < 5 is associated with a moderate risk of hypoglycemia and LBGI > 5 is associated with a high risk of hypoglycemia.
Measured: 40 hours (x2 admissions)
Safety, Frequency of Hypoglycemia
Hypoglycemic episodes are defined as BG < 3.9mmol/L
Measured: 40 hours (x 2 admissions)
Secondary outcomes (1)
Efficacy, Time Spent in Target Range
Percentage of time in the target range of 3.9-10 mmol/L (70-180 mg/dL).
Measured: 40 hours (x2 admissions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionJan 2013
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 Diabetes Mellitus, Type 1Studies 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
- Randomised
- Intervention model
- Crossover
- 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, Sansum Diabetes Research Institute, University of Padova, University Hospital, Montpellier
- Responsible party
- Principal investigator, Boris Kovatchev, PhD, University of Virginia
- Investigators
- Boris P. Kovatchev, Ph.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714505
- Sponsor's protocol ID
- 16457
- Other IDs
- JDRF 22-2011-649
- Status last verified
- Aug 2014
- First submitted
- 23 Oct 2012
- Last updated
- 9 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, Mize LB, Farret A, Place J, Bruttomesso D, Del Favero S, Boscari F, Galasso S, Avogaro A, Magni L, Di Palma F, Toffanin C, Messori M, Dassau E, Doyle FJ 3rd. Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas. Diabetes Care. 2014 Jul;37(7):1789-96. doi: 10.2337/dc13-2076. Epub 2014 Jun 14.
PubMed 24929429
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy
- ClinicalTrials.gov ID
- NCT01714505
- Acronym / sponsor ID
- 16457
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, Continuous Glucose Monitor, Artificial Pancreas, Insulin Pump, Closed Loop control, Open Loop treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Sansum Diabetes Research Institute, University of Padova, University Hospital, Montpellier
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Posted 9 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a hospital based clinical research center. The principal goal is to validate a smart phone-based control-to-range (CTR) system for ambulatory use and to estimate the effect of CTR vs. sensor-augmented pump therapy, thereby providing justification for further larger home-based trials of CTR.
Detailed description
The overall objective of this project is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system for optimal blood glucose (BG) regulation in people with type 1 diabetes. The CTR system is comprised of two algorithmic layers: a Safety Supervision Module (SSM) and Insulin on Board Tracking and Safety Module (ITSM), and an automated Range Correction Module (RCM). Both modules will receive continuous glucose monitoring (CGM) and insulin delivery data. The SSM and ITSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia. The RCM will be responsible for optimizing BG control and mitigating postprandial hyperglycemic excursions through series of insulin boluses. To run CTR, we will use our wearable artificial pancreas platform, known as DiAs (Diabetes Assistant), which consists of a smart phone running CTR and connected to standard insulin delivery and CGM devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Involving Automated CTR | Experimental | Device: Diabetes Assistant (DiAs)Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system. |
| CGM-Augmented Insulin Pump Treatment | No intervention | –Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- ≥21 and <65 years old.
- Clinical diagnosis of type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met.
- o Criteria for documented hyperglycemia (at least 1 must be met): i. Fasting glucose ≥126 mg/dL - confirmed ii. Two-hour Oral Glucose Tolerance Test (OGTT) glucose ≥200 mg/dL - confirmed iii. HbA1c ≥6.5% documented - confirmed iv. Random glucose ≥200 mg/dL with symptoms v. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
- o Criteria for requiring insulin at diagnosis (1 must be met): i. Participant required insulin at diagnosis and continually thereafter ii. 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 iii. 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.
Key exclusion criteria (27 listed)
- Severe hypoglycemia resulting in seizure, loss of consciousness, or diabetic ketoacidosis within the 12 months prior to enrollment.
- Pregnancy; breast feeding, or intention of becoming pregnant.
- Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg).
- Conditions which may increase the risks associated with possible hypoglycemia, such as any active 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.
- Self-reported hypoglycemia unawareness.
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 |
|---|---|---|
| Diabetes Assistant (DiAs)A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night. | Device | Experimental Involving Automated CTR |
Primary outcome
Safety, Low Blood Glucose Index (LBGI)
Time frame: 40 hours (x2 admissions)
The LBGI reflects the frequency and extent of hypoglycemic episodes and presents the results in "risk space." Thus the LBGI is a weighted average of the number of hypoglycemic readings, with progressively increasing weights as BG levels go down. The increase of the weights follows a risk function; thus the LBGI has been associated with risk for hypoglycemia and prediction of severe hypoglycemic episodes. LBGI < 2.5 is associated with low risk of hypoglycemia, 2.5 < LBGI < 5 is associated with a moderate risk of hypoglycemia and LBGI > 5 is associated with a high risk of hypoglycemia.
Safety, Frequency of Hypoglycemia
Time frame: 40 hours (x 2 admissions)
Hypoglycemic episodes are defined as BG < 3.9mmol/L
1 secondary outcome
Efficacy, Time Spent in Target Range
Time frame: 40 hours (x2 admissions)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24929429Kovatchev BP, Renard E, Cobelli C, Zisser HC, Keith-Hynes P, Anderson SM, Brown SA, Chernavvsky DR, Breton MD, Mize LB, Farret A, Place J, Bruttomesso D, Del Favero S, Boscari F, Galasso S, Avogaro A, Magni L, Di Palma F, Toffanin C, Messori M, Dassau E, Doyle FJ 3rd. Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas. Diabetes Care. 2014 Jul;37(7):1789-96. doi: 10.2337/dc13-2076. Epub 2014 Jun 14.
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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. principal investigator
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 testing Diabetes Assistant (DiAs) in people with Diabetes Mellitus, Type 1, 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 11 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 9 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 9 Sep 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?
Safety, Low Blood Glucose Index (LBGI) (time frame: 40 hours (x2 admissions)). The study lists 2 primary outcomes in all. 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 NCT01714505, 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 9 Sep 2014.