Outpatient Control-to-Range: System and Monitoring Testing

NCT01578980 | Completed Results

• 1 other identifier: 16130
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Artificial Pancreas; Type 1 Diabetes Mellitus; Control-to-Range; Closed-Loop Control; Continuous Glucose Monitor

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 for the entire arm.

  42 hours

Secondary Outcomes (1)

• Frequency of Unplanned System Resets or Restarts

  42 hours

Study Arms (1)

Outpatient Control-to-Range

EXPERIMENTAL

Outpatient Control-to-Range: Testing system connectivity

Device: Outpatient Control-to-Range

Interventions

Outpatient Control-to-Range DEVICE

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.

Also known as: Ambulatory Artificial Pancreas

Outpatient Control-to-Range

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• Juvenile Diabetes Research Foundation: collaborator
• University of California, Santa Barbara: collaborator

Study Sites (2)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

• 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.

  PMID: 23801798 RESULT

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

Results Point of Contact

• Title: Boris Kovatchev, PhD
• Organization: University of Virginia

bpk2u@virginia.edu

434-924-5592

Study Officials

• Boris P. Kovatchev, Ph.D.

  University of Virginia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Professor, Director of Center for Diabetes Technology

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 17, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 16, 2014
• Results First Posted: August 25, 2014

Record last verified: 2014-08

Locations

US (2)