Feasibility Study Using Zone-MPC Controller, HMS and Technosphere® Insulin Inhalation System From MannnKind Corp

NCT01874392 | Completed Results

• 1 other identifier: JDRF 17-2010-765
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes using rapid-acting insulin as well as preprandial inhaled insulin (Technosphere® Insulin Inhalation System by MannKind Corporation). The goal of this proposed study is to explore the feasibility of using multiple insulin delivery routes in order to mimic the physiology of both first- and second-phase insulin secretion. The intent is to exploit the rapid action achieved by inhaled insulin to compensate for part of the meals and utilize the conventional subcutaneous route for management of basal insulin and as second-phase meal-related insulin.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.

  This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range 5 hours after meal: \[70-180\] mg/dL.

  5 hours

• Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.

  This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range for the entire study: \[80-140\] mg/dL

  25-28 hours

• Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting

  This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range during exercise: \[70-150\] mg/dL

  30 minutes

• Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting

  This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range 3 hours after exercise: \[70-150\] mg/dL

  3 hours

• Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.

  This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Overnight target range: \[70-180\] mg/dL

  7 hours overnight

Secondary Outcomes (2)

• Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System

  150 minutes

• Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System

  120 minutes

Study Arms (1)

T1DM

EXPERIMENTAL

Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months

Drug: Investigational inhaled insulin (Technosphere); Device: Artificial Pancreas (AP) device (APS©)

Interventions

Investigational inhaled insulin (Technosphere) DRUG

by MannKind Corp. IND 61,729

Also known as: Technosphere® Insulin Inhalation System (Gen2C inhaler)

T1DM

Artificial Pancreas (AP) device (APS©) DEVICE

Device includes: * OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp. * Dexcom® G4® CGM System (CGM) from Dexcom® Corp * Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)

Also known as: Artificial Pancreas System platform (APS©) from the University of California, Santa Barbara and SDRI

T1DM

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months with commercially available rapid actin insulin
• The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
• Age 21 to 65 years
• For females, not currently known to be pregnant or nursing
• HbA1c between 5.0% and 10%, as measured with DCA2000 or equivalent device
• Forced expiratory volume in 1 second (FEV1) ≥ 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
• Forced vital capacity (FVC) ≥70% NHANES III predicted
• Forced expiratory volume in 1 second as a percentage of forced vital capacity(FEVl/FVC)≥NHANES III lower limit of normal (LLN)
• Willing to perform the calibration of the study CGMs using a finger stick only and willing to follow instructions for insulin pump and CGM wear.
• Willing to use the study CGM and study insulin pump during closed-loop.
• Able to and agrees to avoid the following medication starting 24 hours before sensor wear through completion of CRC visit: acetaminophen, and pseudoephedrine.
• An understanding of and willingness to follow the protocol and sign the informed consent.

You may not qualify if:

• Pregnancy (as determined by a positive blood pregnancy test performed in females of childbearing capacity during screening visit and urine test at time of admission for in-patient visit) or nursing mother.
• Diabetic ketoacidosis in the past 6 months prior to enrollment requiring emergency room visit or hospitalization
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
• Current treatment for a seizure disorder;
• o Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist
• Cystic fibrosis
• Active infection
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as cognitive deficit.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write.
• Coronary artery disease or heart failure. oSubjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist
• Presence of a known adrenal disorder
• Active coronary artery disease or heart failure
• Active gastroparesis
• If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
• Uncontrolled thyroid disease

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Related Publications (1)

• Zisser H, Dassau E, Lee JJ, Harvey RA, Bevier W, Doyle FJ 3rd. Clinical results of an automated artificial pancreas using technosphere inhaled insulin to mimic first-phase insulin secretion. J Diabetes Sci Technol. 2015 May;9(3):564-72. doi: 10.1177/1932296815582061. Epub 2015 Apr 21.

  PMID: 25901023 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Director of Research and Innovation
• Organization: Sansum Diabetes Research Institute

dkerr@sansum.org

8056827640

Study Officials

• Howard Zisser, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: June 11, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 11, 2021
• Results First Posted: November 11, 2021

Record last verified: 2021-10

Locations

US (1)