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Type 1 Diabetes MellitusEarly Phase 1HomeCTR1_2NCT01447992

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

A Early Phase 1 study of Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in Italy.

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

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… Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Type 1 Diabetes Mellitus
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteItaly
Study dates
Sep 2011to Apr 2012
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

  • 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
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  • 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
  • Patient must demonstrate proper mental status and cognition for the study
  • Patient must be willing to avoid consumption of acetaminophen-containing products during the study interventions involving DexCom use
  • Patient must be affiliated or beneficiary of a social medical insurance
  • Patient has signed informed consent form prior to study entry

Who cannot join

  • 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
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  • 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)
  • Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase ≥three times the upper reference limit
  • Impaired renal function measured as creatinine >1.2 times above the upper limit of normal
  • Uncontrolled microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment
  • Active gastroparesis requiring current medical therapy
  • 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
  • Known bleeding diathesis or dyscrasia
  • Known allergy to medical adhesives, components of the insulin pump insertion set or continuous glucose monitor sensor
  • Unwillingness to withhold dietary supplements two weeks prior to admission and for the duration of the study participation.
  • Unwillingness to withhold pramlintide, liraglutide and exenatide for the duration of the study intervention.
  • Patient is actively enrolled in another clinical trial or was part of study within 30 days or whose annual study income is over 4 500€
  • Persons deprived of freedom, adults protected by law or vulnerable persons

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedaliera E Universita Degli Study Di Padova

    Padova, Veneto, 35128

Other trials in Italy

About this study

Official title: Pilot Study 1 of Outpatient Control-to-Range - System and Monitoring Testing

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).

Read the detailed description

Automated closed-loop control (CLC), known as "artificial pancreas" (AP) can have tremendous impact on the health and lives of people with type 1 diabetes (T1D). Our inter-institutional and international research team has been on the forefront of CLC developments since the beginning of the Juvenile Diabetes Research Foundation (JDRF) Artificial Pancreas initiative in 2006. Thus far, we have conducted three closed-loop control clinical trials (totaling 60 subjects with T1D), which demonstrated significantly more time in an acceptable "target" blood glucose range during CLC, and significantly fewer hypoglycemic events during CLC compared to open loop. Our overall objective is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and an automated Range Correction Module (RCM). The SSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia, and will also monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations or loss of sensitivity. The RCM will be responsible for the optimal regulation of postprandial hyperglycemic excursions through correction boluses.

The first phase to address our overall objective is a pilot study that will test the ability of a cell-phone-based system to (1) run CTR in an outpatient setting, and (2) be remotely monitored. Specifically, this pilot study entails a hybrid hotel/hospital design targeting adults with T1D that are experienced insulin pump users. Subjects will spend one night in a local hotel, during which the phone-based system will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur. Subjects will spend the following day in the hospital, where CTR will be activated, and challenged with meals and a CGM sensor replacement . Subjects will then spend a second night in the hotel for continued evaluation of remote system monitoring, along with outpatient testing of the CTR system run on the phone-based system. This series of admissions will address the first major hurdles that need to be overcome for home deployment of a closed loop CTR system:

Specific Aim 1: The phone-based CTR system can be remotely monitored by nurses/physicians/technicians to confirm appropriate functioning outside of the hospital setting.

Specific Aim 2: The CTR can be deployed outside of the hospital setting.

Being tested
Portable artificial pancreas system with Control-To-Range
Keywords
Artificial Pancreas, Insulin Pump, Continuous Glucose Monitor, Closed Loop
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 pancreas system with Control-To-RangeDevice

    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.

Study groups in NCT01447992
Study groupRoleWhat they receive
Portable artificial pancreas system with Control-To-RangeExperimentalNot described
Receives: Device: Portable artificial pancreas system with Control-To-Range

What is being measured

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

  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).

    Measured: length of admission (hour 42)

Secondary outcomes (2)

  1. frequency analysis of lost or inaccurate CGM records

    number of CGM data points not received (or corrupted) by the device divided by the total number of possible CGM data points to be received.

    Measured: length of admission (42 hours)

  2. percent time of active CTR

    number of minutes the Control-To-Range system was functioning properly (computation of insulin infusion, and insulin actually delivered) divided by the maximum number of minutes the CTR system should have been active (as per protocol)

    Measured: length of admission (42h)

Timeline

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

  1. First posted6 Oct 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionApr 2012
  4. Study completionApr 2012

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01447992
Sponsor's protocol ID
2433P
Other IDs
JDRF 22-2011-649
Acronym
HomeCTR1_2
Status last verified
Jun 2014
First submitted
29 Sep 2011
Last updated
19 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23801798

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study of Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in Italy.

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 19 inclusion and 27 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 19 Jun 2014. 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 Italy. 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?

estimation of the failure rates of system components (time frame: length of admission (hour 42)). 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 NCT01447992, 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 19 Jun 2014.

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