Outpatient Control-to-Range: System and Monitoring Testing
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outpatient Control-to-Range
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Artificial Pancreas, Type 1 Diabetes Mellitus, Control-to-Range, Closed-Loop Control, Continuous Glucose Monitor
Eligibility Criteria
INCLUSION CRITERIA
- ≥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
- 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
EXCLUSION CRITERIA
- 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
- 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
Sites / Locations
- Sansum Diabetes Research Institute
- University of Virginia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Outpatient Control-to-Range
Arm Description
Outpatient Control-to-Range: Testing system connectivity
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01578980
First Posted
April 13, 2012
Last Updated
September 5, 2014
Sponsor
University of Virginia
Collaborators
Juvenile Diabetes Research Foundation, University of California, Santa Barbara
1. Study Identification
Unique Protocol Identification Number
NCT01578980
Brief Title
Outpatient Control-to-Range: System and Monitoring Testing
Official Title
Outpatient Control-to-Range: System and Monitoring Testing
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Juvenile Diabetes Research Foundation, University of California, Santa Barbara
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Artificial Pancreas, Type 1 Diabetes Mellitus, Control-to-Range, Closed-Loop Control, Continuous Glucose Monitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Outpatient Control-to-Range
Arm Type
Experimental
Arm Description
Outpatient Control-to-Range: Testing system connectivity
Intervention Type
Device
Intervention Name(s)
Outpatient Control-to-Range
Other Intervention Name(s)
Ambulatory Artificial Pancreas
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Time of Active CTR
Description
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.
Time Frame
42 hours
Secondary Outcome Measure Information:
Title
Frequency of Unplanned System Resets or Restarts
Description
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.
Time Frame
42 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA
≥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
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
EXCLUSION CRITERIA
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris P. Kovatchev, Ph.D.
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23801798
Citation
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.
Results Reference
result
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