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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

DiAs Diabetes Assistant Wearable Artificial Pancreas Platform

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 diabetes mellitus, closed loop artificial pancreas

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 BG and active insulin.
HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device
Not currently known to be pregnant, breast feeding, or intending to become pregnant (females)
Demonstration of proper mental status and cognition for the study
Willingness to avoid consumption of acetaminophen-containing products during the study interventions involving DexCom use
If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study

Exclusion 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 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 BG and active insulin.
HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device
Not currently known to be pregnant, breast feeding, or intending to become pregnant (females)
Demonstration of proper mental status and cognition for the study
Willingness to avoid consumption of acetaminophen-containing products during the study interventions involving DexCom use
If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study

Sites / Locations

Sansum Diabetes Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Control to Range Testing

Arm Description

Subjects will spend two nights in a non hospital setting while the DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is remotely monitored from an adjacent room. DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings.

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.

Secondary Outcome Measures

Frequency analysis of failed data caused by system components

The failed data records will be compared to failure/missing data records from our past in-clinic studies

Frequency of inaccurate data caused by system components

Continuous glucose sensor data will be compared with Hemocue data for accuracy.

Frequency analysis of lost data caused by system components

The failure/missing data records will be compared to missing data records from our past in-clinic studies

Full Information

NCT ID

NCT01697150

First Posted

April 19, 2012

Last Updated

April 20, 2016

Sponsor

Sansum Diabetes Research Institute

Collaborators

University of California, Santa Barbara, University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT01697150

Brief Title

Outpatient Control-to-Range: System and Monitoring Testing

Official Title

Systems Approach to Closed-Loop Control of Type 1 Diabetes at Home

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sansum Diabetes Research Institute

Collaborators

University of California, Santa Barbara, University of Virginia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Automated closed-loop control (CLC) of blood glucose, known as "artificial pancreas" (AP) can have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). The investigators inter-institutional and international research team has been on the forefront of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006. Thus far, the investigators have conducted three closed-loop control clinical trials (totaling 60 subjects with T1DM), which demonstrated significantly more time in an acceptable "target" blood glucose range during CLC, and significantly fewer hypoglycemic events during CLC compared to open loop. The investigators overall objective is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and a Hypoglycemia Mitigation Module (HMM). The SSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia and will also monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations or loss of sensitivity. The HMM will be responsible for the optimal regulation of postprandial hyperglycemic excursions through correction boluses. This study will test the ability of AP Platform to (1) run CTR in an outpatient setting, and (2) be remotely monitored. Specifically, this study involves studying adults with T1DM who are experienced insulin pump users. Subjects will spend two nights (-42 hours) in a local hotel, during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur. During the study, study subject will be responsible for. operating the CTR system with nursing and technicians available

Detailed Description

I.A. PURPOSE/OBJECTIVES Primary objective The purpose of this pilot study is to test a closed-loop Control-to-Range (CTR) system in a semi-controlled environment and especially to evaluate if the system can accurately collect data coming from patient inputs, insulin pump, and continuous glucose monitoring (CGM) device with more than 80% of time of use. Secondary objectives This pilot study will use a Artificial Pancreas Platform (AP Platform) cell phone/phone-based system to test an outpatient controller and remote monitoring as follows: test that the CTR system can be remotely monitored by nurses/physicians/ technicians to confirm appropriate functioning outside of the hospital setting test that the CTR system can be deployed, with appropriate subject response, outside of the hospital setting I.B. STUDY DESIGN This study is an early feasibility pilot trial with the principal goal is to validate an initial outpatient ready CTR system and its remote-monitoring capability. Therefore, this is an unblinded pilot study and no control group will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitus, closed loop artificial pancreas

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control to Range Testing

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

DiAs Diabetes Assistant Wearable Artificial Pancreas Platform

Intervention Description

Subjects will spend two nights in a non hospital setting while the Artificial Pancreas Device System is remotely monitored from an adjacent room. Artificial Pancreas Device System is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings.

Primary Outcome Measure Information:

Title

Percent time of active CTR

Description

Time Frame

42 hours

Secondary Outcome Measure Information:

Title

Frequency analysis of failed data caused by system components

Description

The failed data records will be compared to failure/missing data records from our past in-clinic studies

Time Frame

42 hours

Title

Frequency of inaccurate data caused by system components

Description

Continuous glucose sensor data will be compared with Hemocue data for accuracy.

Time Frame

42 hours

Title

Frequency analysis of lost data caused by system components

Description

The failure/missing data records will be compared to 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

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 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 BG and active insulin. HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device Not currently known to be pregnant, breast feeding, or intending to become pregnant (females) Demonstration of proper mental status and cognition for the study Willingness to avoid consumption of acetaminophen-containing products during the study interventions involving DexCom use If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study Exclusion 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 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 BG and active insulin. HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device Not currently known to be pregnant, breast feeding, or intending to become pregnant (females) Demonstration of proper mental status and cognition for the study Willingness to avoid consumption of acetaminophen-containing products during the study interventions involving DexCom use If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Howard Zisser, MD

Organizational Affiliation

Sansum Diabetes Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sansum Diabetes Research Institute

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.sansum.org

Description

http://www.sansum.org/research-trials/current-trials/

Learn more about this trial

Outpatient Control-to-Range: System and Monitoring Testing

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