Outpatient Control-to-Range: System and Monitoring Testing

NCT01697150 | Completed

• 1 other identifier: JDRF 22-2011-649 SB
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitus; closed loop artificial pancreas

Outcome Measures

Primary Outcomes (1)

• 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.

  42 hours

Secondary Outcomes (3)

• Frequency analysis of failed data caused by system components

  42 hours

• Frequency of inaccurate data caused by system components

  42 hours

• Frequency analysis of lost data caused by system components

  42 hours

Study Arms (1)

Control to Range Testing

EXPERIMENTAL

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.

Device: DiAs Diabetes Assistant Wearable Artificial Pancreas Platform

Interventions

DiAs Diabetes Assistant Wearable Artificial Pancreas Platform DEVICE

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.

Control to Range Testing

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• ≥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

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• University of California, Santa Barbara: collaborator
• University of Virginia: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Howard Zisser, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research and Diabetes Technology

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: October 2, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

US (1)