Pilot Study 1 of Outpatient Control-to-Range - System and Monitoring Testing

NCT01470807 | Completed

• 1 other identifier: 0054961
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

A single arm, single treatment study is proposed to assess the feasibility of a portable artificial pancreas system outside of a hospital based clinical research center. Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions (hotel).

Conditions

Type 1 Diabetes Mellitus

Keywords

Artificial Pancreas; Insulin Pump; Continuous Glucose Monitor; Closed Loop

Outcome Measures

Primary Outcomes (1)

• estimation of the failure rates of system components

  the investigators will estimate the frequency of failures (#failures/day) of each following system components: CGM communication, pump communication, insulin dose computation, user interface.

  length of admission (hour 42)

Secondary Outcomes (2)

• frequency analysis of lost or inaccurate CGM records

  length of admission (42 hours)

• percent time of active CTR

  length of admission (42h)

Study Arms (1)

portable artificial pancreas system with CTR algorithms

EXPERIMENTAL

This is the only arm of the study and concerns all patients.

Device: portable artificial pancreas system with CTR algorithms

Interventions

portable artificial pancreas system with CTR algorithms DEVICE

The investigators will test the new portable CTR system in CRC conditions for 10h followed by 18h of CTR in a hotel.

portable artificial pancreas system with CTR algorithms

Eligibility Criteria

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

You may qualify if:

• Patient must be aged between 21 (inclusive) and 65 years old. The age of 21 has been chosen because this trial is supported by a US Foundation.
• Patient must have been clinically diagnosed with Type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met:
• Criteria for documented hyperglycemia (at least 1 must be met):
• Fasting glucose ≥126 mg/dL - confirmed
• Two-hour OGTT glucose ≥200 mg/dL - confirmed
• HbA1c ≥6.5% documented - 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 (1 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 a carbohydrate \[CHO\] / insulin ratio for insulin bolus adjustments in order to keep blood glucose in a predefined range
• Patient HbA1c is between 6.0% and 9% 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 or loss of consciousness in the 12 months prior to enrollment
• 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 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
• 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 DexCom 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)

Sponsors & Collaborators

• University of Virginia: lead
• University Hospital, Montpellier: collaborator
• University of Padova: collaborator
• University of California, Santa Barbara: collaborator

Study Sites (1)

University of Padova

Padua, Italy

Location

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

• Claudio Cobelli, Ph.D.

  University of Padova

  PRINCIPAL INVESTIGATOR

• Boris Kovatchev, Ph.D.

  University of Virginia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

IT (1)