Feasibility Study of a Portable Artificial Pancreas System in Type 1 Diabetes Mellitus (T1DM) - Padova

NCT01447992 | Completed Early Phase 1

• 2 other identifiers: 2433PJDRF 22-2011-649
• 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

  we will estimate the relative frequency of failures (#failures/opportunity of failure) of each following system components: CGM communication (1 failure opportunity every 5min), pump communication (1 failure opportunity every 5min), insulin dose computation (1 failure opportunity every 5min), user interface (1 failure opportunity every 1min).

  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 Control-To-Range

EXPERIMENTAL

Device: Portable artificial pancreas system with Control-To-Range

Interventions

Portable artificial pancreas system with Control-To-Range DEVICE

We will test the new portable Control-To-Range system in clinical research center conditions for 10 hours followed by 18 hours of Control-To-Range in a hotel.

Portable artificial pancreas system with 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:

• 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 Oral Glucose Tolerance Test (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 of Padova: collaborator
• University Hospital, Montpellier: collaborator
• University of California, Santa Barbara: collaborator

Study Sites (1)

Azienda Ospedaliera E Universita Degli Study Di Padova

Padua, Veneto, 35128, Italy

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 DERIVED

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

• Angelo Avogaro, MD

  University of Padova Hospital

  PRINCIPAL INVESTIGATOR

• Boris Kovatchev, PhD

  University of Virginia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 6, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 19, 2014

Record last verified: 2014-06

Locations

IT (1)