Type 1 Diabetes MellitusNCT01874392

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

A study testing Investigational inhaled insulin (Technosphere) and Artificial Pancreas (AP) device (APS©) in people with Type 1 Diabetes Mellitus, run by Sansum Diabetes Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Type 1 Diabetes Mellitus
What is being tested?: Investigational inhaled insulin (Technosphere) and Artificial Pancreas (AP) device (APS©)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: Oct 2012to Jun 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

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.

Who cannot join

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

Show all 38Show fewer

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
o Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
Abuse of alcohol
A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
Current use of a beta blocker medication
Laboratory results:
Hematocrit < 30% or >55%
A1C > 10%
Abnormal liver or renal function (Transaminase >2 times the upper limit of normal, Creatinine> 1.5 mg/dL)
Labs drawn at screening visit or within one month prior to screening (for other purposes) will suffice for enrollment purposes related to hematocrit
Subject has skin conditions that, in the determination of the investigator, would preclude wearing the study devices (infusion set and sensor), in the abdomen. Examples include but are not limited to: psoriasis, burns, scaring, eczema, tattoos, and significant hypertrophy at sites of device wear; any known allergy to medical adhesives.
Currently on long-term treatment using prednisone.
If subject had been on short term treatment of prednisone, defer enrollment until underlying condition and prednisone treatment have resolved.
Allergy to study drug, food or other study material
History of asthma, COPD (chronic obstructive pulmonary disease), or any other clinically relevant chronic lung disease
Respiratory track infection within 4 weeks before screening
Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
Exposure to any investigational drug within 30 days.
History of malignancy within the 5 years before screening (other than basal cell carcinoma)
Inability, in the opinion of the investigator, to adequately inhale Technosphere® Inhalation powder
Abnormal spirometry
Currently smoking or discontinued smoking (including cigarettes, cigars, pipes) over the past 6 months.
Highly sensitive to insulin: insulin-to-carbohydrate ratio I:C > 1:12.
Current participation in another investigational trial (unless participation to original protocol of IDE G110093) or has previously participated to this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sansum Diabetes Research Institute
Santa Barbara, California, 93105

Other trials in United States

About this study

Official title: Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS) and Technosphere® Insulin Inhalation System From MannnKind Corp.

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
Being tested: Investigational inhaled insulin (Technosphere), Artificial Pancreas (AP) device (APS©)
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational inhaled insulin (Technosphere)Drug
Also called Technosphere® Insulin Inhalation System (Gen2C inhaler)
by MannKind Corp. IND 61,729
Artificial Pancreas (AP) device (APS©)Device
Also called Artificial Pancreas System platform (APS©) from the University of California, Santa Barbara and SDRI
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)

Study groups in NCT01874392
Study group	Role	What they receive
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 Receives: Drug: Investigational inhaled insulin (Technosphere); Device: Artificial Pancreas (AP) device (APS©)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 hours overnight

Secondary outcomes (2)

Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System
To evaluate the performance of the AP device combined with the Technosphere® Insulin Powder System after dinner by measuring the postprandial excursion of blood glucose.
Measured: 150 minutes
Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System
To evaluate the performance of the AP device combined with the Technosphere® Insulin Powder System after breakfast by measuring the postprandial excursion of blood glucose
Measured: 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Jun 2013

First posted11 Jun 2013 (estimated)
Study startOct 2012
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01874392
Sponsor's protocol ID: JDRF 17-2010-765
Status last verified: Oct 2021
First submitted: 14 May 2013
Last updated: 11 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25901023

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS) and Technosphere® Insulin Inhalation System From MannnKind Corp.
ClinicalTrials.gov ID: NCT01874392
Acronym / sponsor ID: JDRF 17-2010-765
Conditions: Type 1 Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Sansum Diabetes Research InstituteUniversity, hospital or other
Collaborators: Juvenile Diabetes Research Foundation
Study start: Oct 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 11 Jun 2013 (estimated)
Results: Posted 11 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
T1DM	Experimental	Drug: Investigational inhaled insulin (Technosphere), Device: Artificial Pancreas (AP) device (APS©)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

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (38 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Investigational inhaled insulin (Technosphere)Also: Technosphere® Insulin Inhalation System (Gen2C inhaler)by MannKind Corp. IND 61,729	Drug	T1DM
Artificial Pancreas (AP) device (APS©)Also: Artificial Pancreas System platform (APS©) from the University of California, Santa Barbara and SDRIDevice 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)	Device	T1DM

Primary outcome

Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.
Time frame: 5 hours
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.
Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.
Time frame: 25-28 hours
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
Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting
Time frame: 30 minutes
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
Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting
Time frame: 3 hours
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
Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.
Time frame: 7 hours overnight
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

2 secondary outcomes

Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System
Time frame: 150 minutes
Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System
Time frame: 120 minutes

Results and safety

Results posted to the registry on 11 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T1DM	9	9

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

Time frame: 5 hours. Median (Inter-Quartile Range). Unit: percentage time in range (70 - 180 mg/dL

Measure	T1DM n = 9
Value	81.6 (72.5 to 85.0)

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

Time frame: 25-28 hours. Median (Inter-Quartile Range). Unit: percentage time in range(80-140mg/dL)

Measure	T1DM n = 9
Value	67.5 (48.5 to 73.1)

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

Time frame: 30 minutes. Median (Inter-Quartile Range). Unit: percentage time in range (70-150 mg/dL)

Measure	T1DM n = 9
Value	94.4 (91.6 to 94.4)

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

Time frame: 3 hours. Median (Inter-Quartile Range). Unit: percentage time in range (70-150 mg/dL)

Measure	T1DM n = 9
Value	94.4 (91.6 to 94.4)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 25-28 hours. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T1DM	0 of 9 (0%)	0 of 9 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25901023Zisser 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Howard Zisser, MD principal investigator

Sansum Diabetes Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting. (time frame: 5 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01874392, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.