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Type 1 DiabetesPhase 1CTRNCT01271023

Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System

A Phase 1 study of Type 1 Diabetes, run by Jaeb Center for Health Research at 7 sites in 4 countries.

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 study is to test an insulin management system ("Control-to-Range (CTR) system") in an inpatient setting to see if the system is safe and effective enough to test in a future at-home study. Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Type 1 Diabetes
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
7 sitesin 4 countries
Study dates
Mar 2011to Aug 2012
Phase
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 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, 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 The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
  • Age 12 to 65 years
  • Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
  • For females, not currently known to be pregnant
  • Demonstration of proper mental status and cognition for the study
  • An understanding of and willingness to follow the protocol and sign the informed consent or assent

Who cannot join

  • Diabetic ketoacidosis in the past 6 months
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
  • History of a seizure disorder (except hypoglycemic seizure). Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist treatment for a seizure disorder
  • 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
  • Cystic fibrosis
  • Active infection
Show all 18Show fewer
  • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
  • Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
  • Presence of a known adrenal disorder
  • Abnormal liver or renal function (Transaminase >2 times the upper limit of normal, Creatinine > 1.5 mg/dL)
  • 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
  • Abuse of alcohol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
  • 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% (labs drawn at screening visit or within one month prior to screening for other purposes will suffice for enrollment purposes related to hematocrit)
  • Use of pseudoephedrine 48 hours prior to Clinical Research Center (CRC) admission

Trial locations and contacts

7 sites in 4 countries.

7 sites in 4 countries

United States4 sites

  • University of Colorado Health Sciences Center- Barbara Davis

    Aurora, Colorado, 80045

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105

  • Stanford University

    Stanford, California, 94305

Other trials in United States

France1 site

  • Montpellier University Hospital

    Montpellier, 34295

Other trials in France

Israel1 site

  • Schneider Children's Medical Center of Israel

    Petah Tikva, 49202

Other trials in Israel

Italy1 site

  • University of Padova

    Padova, 93106

Other trials in Italy

About this study

The purpose of this study is to test an insulin management system ("Control-to-Range (CTR) system") in an inpatient setting to see if the system is safe and effective enough to test in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the insulin.

The study will include two hospital stays consisting of meals and exercise scenarios. Both hospital stays will be for 24+ hours during the day and night. The study will include about 50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.

Read the detailed description

Clinical Research Center (CRC) Session Detail (closed-loop control active for all elements)

Day 1 (24+ hours):

  1. Admission at 7:00 AM
  2. Standardized breakfast with normal bolus at 9:00 AM
  3. Lunch with normal bolus at 1:00 PM
  4. Dinner with normal bolus at 7:00 PM
  5. Overnight sleep
  6. Breakfast with missed meal bolus followed by user alert and correction bolus
  7. Discharge

Day 2 (24+ hours):

  1. Admission at 7:00 AM
  2. Standardized breakfast with normal bolus at 9:00 AM
  3. Lunch with normal bolus at 1:00 PM
  4. Exercise
  5. Dinner with normal bolus at 7:00 PM
  6. Overnight sleep
  7. Breakfast with overbolus at 7:00 AM
  8. Discharge

Meal boluses will be semi-automated, with manual meal announcement by the physician/nurse, automated bolus recommendation by the system, and automated delivery of the bolus following confirmation of the recommendation. Between-meal insulin dosing will be fully automated; bolus confirmation by the physician/nurse will be requested by the closed-loop controller only when it determines that carbohydrates may be necessary to avoid hypoglycemia following the bolus.

Conditions
Type 1 Diabetes
Being tested
Control-to-Range Automated Insulin Management System
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.

  • Control-to-Range Automated Insulin Management SystemDevice

    The devices that will be used in the Closed-Loop Control System are standardized across all study sites and include the DexCom Seven Plus Continuous Glucose Monitor (CGM), the OmniPod insulin pump, and the FreeStyle blood glucose meter. The Closed-Loop Control System will be used during all 3 admission visits.

Study groups in NCT01271023
Study groupRoleWhat they receive
Closed-Loop ControlExperimentalThe Control to Range algorithm will be used in conjunction with continuous glucose monitoring and insulin pump delivery to manage the subject's blood glucose.
Receives: Device: Control-to-Range Automated Insulin Management System

What is being measured

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

  1. Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit

    Group success criterion defined as a mean blood glucose >50%, lower end of one-sided 95% confidence interval >40% and individual criterion of no individual <30%.

    Measured: Admission Visit 1

  2. Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus

    Success is defined as >=40% subjects with a blood glucose in the 71-180 mg/dL range.

    Measured: 4 hours following the breakfast with a missed meal bolus

  3. Percent of subjects with blood glucose reading of 71-180 mg/dL 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount

    Success is defined as >=50% subjects with a blood glucose in the 71-180 mg/dL range.

    Measured: 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount

  4. Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise

    Success is defined as less than 25% of subjects with a blood glucose nadir <=60 mg/dL.

    Measured: Following exercise completion

  5. Overall frequency of hypoglycemia

    Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.

    Measured: Includes both admission visits

  6. Overall frequency of hyperglycemia

    Success defined as no subjects with diabetic ketoacidosis (DKA).

    Measured: Includes both admission visits

Secondary outcomes (8)

  1. Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit

    Group success criterion defined as a mean blood glucose >50%, lower end of one-sided 95% confidence interval >40% and individual criterion of no individual <30%.

    Measured: Admission Visit Day 1 (9:00AM-11:00PM)

  2. Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit

    Group success criterian defined as a mean blood glucose >60%, lower end of one-sided 95% confidence interval >50% and individual criterion of no individual <30%.

    Measured: Admission Visit Night 1 (11:00PM-8:00AM)

  3. Percent of blood glucose values >400 mg/dL during the first admission visit

    Individual success is defined as no blood glucose values >400 mg/dL.

    Measured: Admission Visit 1

  4. Percent of blood glucose values <=60 mg/dL during the first admission visit

    No more than 33% of visits with blood glucose <=60 mg/dL

    Measured: Admission Visit 1

  5. Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus

    Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL

    Measured: 4 hours following the breakfast with a missed meal bolus

  6. Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus

    Success is defined as less than 15% of subjects have a nadir blood glucose <=60 mg/dL

    Measured: 4 hours following the breakfast with a missed meal bolus

  7. Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount

    Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL

    Measured: following the breakfast with a meal bolus 30% more than the recommended bolus amount

  8. Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount

    Success is defined as less than 25% of subjects have a nadir blood glucose <=60 mg/dL

    Measured: following the breakfast with a meal bolus 30% more than the recommended bolus amount

Timeline

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

  1. First posted6 Jan 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionAug 2012
  4. Study completionAug 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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01271023
Sponsor's protocol ID
CTR
Acronym
CTR
Status last verified
Sep 2016
First submitted
4 Jan 2011
Last updated
9 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Chase HP, Doyle FJ 3rd, Zisser H, Renard E, Nimri R, Cobelli C, Buckingham BA, Maahs DM, Anderson S, Magni L, Lum J, Calhoun P, Kollman C, Beck RW; Control to Range Study Group. Multicenter closed-loop/hybrid meal bolus insulin delivery with type 1 diabetes. Diabetes Technol Ther. 2014 Oct;16(10):623-32. doi: 10.1089/dia.2014.0050. Epub 2014 Sep 4.

    PubMed 25188375

  • Zisser H, Renard E, Kovatchev B, Cobelli C, Avogaro A, Nimri R, Magni L, Buckingham BA, Chase HP, Doyle FJ 3rd, Lum J, Calhoun P, Kollman C, Dassau E, Farret A, Place J, Breton M, Anderson SM, Dalla Man C, Del Favero S, Bruttomesso D, Filippi A, Scotton R, Phillip M, Atlas E, Muller I, Miller S, Toffanin C, Raimondo DM, De Nicolao G, Beck RW; Control to Range Study Group. Multicenter closed-loop insulin delivery study points to challenges for keeping blood glucose in a safe range by a control algorithm in adults and adolescents with type 1 diabetes from various sites. Diabetes Technol Ther. 2014 Oct;16(10):613-22. doi: 10.1089/dia.2014.0066. Epub 2014 Jul 8.

    PubMed 25003311

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Type 1 Diabetes, run by Jaeb Center for Health Research at 7 sites in 4 countries.

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 6 inclusion and 18 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, France, Israel, 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit (time frame: Admission Visit 1). The study lists 6 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 NCT01271023, which also lists 2 linked publications.

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 9 Sep 2016.

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