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Type 1 Diabetes MellitusEarly Phase 1DP3NCT01929798

Crossover Feasibility Study of Portable AP Device With Zone-MPC and HMS and Adapted I:C and Basal Insulin

A Early Phase 1 study testing portable Artificial Pancreas 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

The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1 diabetes using an insulin pump and rapid acting insulin. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
portable Artificial Pancreas
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Nov 2013to Nov 2014
Phase
Early Phase 1
Are there results?
None posted in the registry

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 acting 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 ≤ to 10%, as measured with DCA2000 or equivalent device
  • 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.
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  • 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 the close loop study visit: acetaminophen, prednisone, 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.
  • Females who are sexually active and able to conceive that do not use contraception.
  • Any documented arrhythmias.
  • 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; Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist
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  • 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. Subjects 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 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. 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
  • 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.
  • 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).
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sansum Diabetes Research Institutute

    Santa Barbara, California, 93105

Other trials in United States

About this study

Official title: Randomized Crossover Feasibility Study of Artificial Pancreas Device (AP) Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS) With and Without Basal and Insulin-to-Carbohydrate Bolus Initialization

The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1 diabetes using an insulin pump and rapid acting insulin. This proposed study is designed to compare closed-loop control with or without optimization of initialization parameters related to basal insulin infusion rates and insulin to carbohydrate (I:C) ratios for meals and snacks.

Read the detailed description

The study consists of an evaluation of the Artificial Pancreas device system during two 24-27.5-hour closed-loop phases in an outpatient/hotel environment. Prior to the closed-loop phases, each subject will undergo a 7-day data collection period consisting of his or her usual free-living conditions along with 3 meals of known carbohydrate content. Data from the insulin pump, a continuous glucose monitoring sensor (CGM), diet and exercise records will be collected during this period. These data from this 7-day period will be analyzed in order to come up with adapted basal insulin infusion rates and bolus insulin to carbohydrate (I:C) ratios.

Being tested
portable Artificial Pancreas
Keywords
artificial pancreas
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.

  • portable Artificial PancreasDevice

    The artificial pancreas system will be allowed to employ its Model Predictive Control algorithm to make decisions about insulin delivery based on measured glucose levels.

Study groups in NCT01929798
Study groupRoleWhat they receive
Optimized basal/bolus with artificial pancreasExperimentalPortable artificial pancreas with optimization
Receives: Device: portable Artificial Pancreas
Nominal basal/bolus treatmentNo interventionPortable artificial pancreas without optimization.

What is being measured

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

  1. time spent in safe blood glucose range

    The percentage time spent in safe blood glucose range of [80-140] mg/dl will be the primary endpoint. More time spent inside the desired range will be considered successful. Expected levels are [70-180] mg/dl the 5 hours after meals and [70-150] mg/dl 3 hours after exercise.

    Measured: 24-hour closed-loop

Secondary outcomes (1)

  1. glucose level extremes and need for outside intervention

    The secondary endpoint measures glucose extremes and the need for outside intervention to prevent hypoglycemia or hyperglycemia. Interventions would be insulin injections or oral carbohydrates given to the subject by the physician. No need for physician intervention will be considered a successful outcome.

    Measured: 24-hour closed loop

Timeline

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

  1. First posted28 Aug 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

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

Study design
Study type
Interventional
Phase
Early Phase 1
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01929798
Sponsor's protocol ID
DP301
Acronym
DP3
Status last verified
Oct 2015
First submitted
15 Aug 2013
Last updated
21 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Dassau E, Brown SA, Basu A, Pinsker JE, Kudva YC, Gondhalekar R, Patek S, Lv D, Schiavon M, Lee JB, Dalla Man C, Hinshaw L, Castorino K, Mallad A, Dadlani V, McCrady-Spitzer SK, McElwee-Malloy M, Wakeman CA, Bevier WC, Bradley PK, Kovatchev B, Cobelli C, Zisser HC, Doyle FJ 3rd. Adjustment of Open-Loop Settings to Improve Closed-Loop Results in Type 1 Diabetes: A Multicenter Randomized Trial. J Clin Endocrinol Metab. 2015 Oct;100(10):3878-86. doi: 10.1210/jc.2015-2081. Epub 2015 Jul 23.

    PubMed 26204135

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing portable Artificial Pancreas in people with Type 1 Diabetes Mellitus, run by Sansum Diabetes Research Institute at 1 site in United States.

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 9 inclusion and 31 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 21 Oct 2015. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

time spent in safe blood glucose range (time frame: 24-hour closed-loop). 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 NCT01929798, 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 21 Oct 2015.

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DP3 Clinical Trial NCT01929798 | AzTrials