Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy (Italy)

NCT01727817 | Completed

• 2 other identifiers: 0052904JDRF 22-2011-649
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control to Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a hospital based clinical research center.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1; Continuous Glucose Monitor; Artificial Pancreas; Insulin Pump; Closed Loop; Open Loop; Diabetes Assistant; DiAs; Cell Phone

Outcome Measures

Primary Outcomes (1)

• Effect size of Control-to-Range (CTR) vs. Continuous Glucose Monitor (CGM)-augmented insulin pump treatment in an outpatient setting.

  The investigators expect that compared to CGM-augmented insulin pump treatment, CTR will result in moderate effect size of approximately 0.4, in terms of reduction of the overnight risk for hypoglycemia as measured by the Low Blood Glucose Index computed from retrofitted CGM data. This effect is not expected to be statistically significant with the anticipated sample size but will be used to inform power analysis for the subsequent multi-center trial of CTR at home.

  40 hours

Secondary Outcomes (1)

• Time spent in target range

  40 hours

Other Outcomes (3)

• Patient comfort with the Diabetes Assistant (DiAs) user interface

  40 hours

• Reliability of DiAs remote monitoring

  40 hours

• Reliability of inter-device connections between DiAs and the CGM and between DiAs and the insulin pump.

  40 hours

Study Arms (2)

Experimental Involving Automated CTR

EXPERIMENTAL

Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. Subjects will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.

Device: Diabetes Assistant (DiAs)

CGM-Augmented Insulin Pump Treatment

NO INTERVENTION

Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. Subjects will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. Subjects will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.

Interventions

Diabetes Assistant (DiAs) DEVICE

A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.

Experimental Involving Automated CTR

Eligibility Criteria

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

You may qualify if:

• ≥21 and \<65 years old.
• Clinical diagnosis of type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met.
• o Criteria for documented hyperglycemia (at least 1 must be met): i. Fasting glucose ≥126 mg/dL - confirmed ii. Two-hour Oral Glucose Tolerance Test (OGTT) glucose ≥200 mg/dL - confirmed iii. HbA1c ≥6.5% documented - confirmed iv. Random glucose ≥200 mg/dL with symptoms v. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
• o Criteria for requiring insulin at diagnosis (1 must be met): i. Participant required insulin at diagnosis and continually thereafter ii. 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 iii. 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.
• Familiarity with a bolus calculator with the current insulin pump with pre-defined parameters for carbohydrate (CHO) ratio, insulin sensitivity factor (ISF), target glucose and active insulin.
• HbA1c \<9% 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 CGM 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.

You may not qualify if:

• Severe hypoglycemia resulting in seizure, loss of consciousness, or diabetic ketoacidosis within the 12 months prior to enrollment.
• Pregnancy; breast feeding, or intention of becoming pregnant.
• Uncontrolled arterial hypertension (Resting diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg).
• Conditions which may increase the risks associated with possible hypoglycemia, such as any active 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.
• Self-reported hypoglycemia unawareness.
• 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.
• Medical conditions that would make operating a CGM, the DiAs 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
• Juvenile Diabetes Research Foundation: collaborator
• Sansum Diabetes Research Institute: collaborator
• University Hospital, Montpellier: collaborator

Study Sites (1)

University of Padova

Padua, 35131, Italy

Location

Related Publications (1)

• Kovatchev BP, Renard E, Cobelli C, Zisser HC, Keith-Hynes P, Anderson SM, Brown SA, Chernavvsky DR, Breton MD, Mize LB, Farret A, Place J, Bruttomesso D, Del Favero S, Boscari F, Galasso S, Avogaro A, Magni L, Di Palma F, Toffanin C, Messori M, Dassau E, Doyle FJ 3rd. Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas. Diabetes Care. 2014 Jul;37(7):1789-96. doi: 10.2337/dc13-2076. Epub 2014 Jun 14.

  PMID: 24929429 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

• Claudio Cobelli, Ph.D.

  University of Padova

  PRINCIPAL INVESTIGATOR

• Boris P. Kovatchev, Ph.D.

  University of Virginia

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 16, 2012
• Study Start: January 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

IT (1)