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Diabetes Mellitus, Type 1Early Phase 1NCT01484457

Controlled Insulin Delivery: Combining Technology With Treatment

A Early Phase 1 study testing Closed-loop session in people with Diabetes Mellitus, Type 1, run by Sansum Diabetes Research Institute at 2 sites in 2 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

Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric model predictive control can be developed and evaluated safely in patients with Type 1 Diabetes Mellitus (T1DM) to control blood glucose concentrations. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Closed-loop session
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
2 sitesin 2 countries
Study dates
Jul 2008to Jan 2010
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing to sign the consent form
  • Type 1 diabetes for at least 1 year prior to the study
  • Using continuous subcutaneous insulin infusion pump
  • Above 21 years of age
  • Willing to follow the study requirements

Who cannot join

  • Allergy to the sensor or to one of its components
  • Psychiatric disorders
  • Reported diabetic ketoacidosis within last 3 months
  • Abnormal liver function (Transaminase > 2 times the upper limit of normal)
  • Heart failure
  • Any carcinogenic disease
Show all 18Show fewer
  • Any other chronic abnormality
  • Unwilling to perform or to follow the research protocol
  • Participation in any other study concurrent with the proposed study
  • Creatinine concentration above the upper limit of normal for age and sex
  • Active coronary artery disease
  • Active gastroparesis
  • History of uncontrolled seizures
  • Pregnancy
  • Untreated adrenal insufficiency
  • Hypokalemia
  • Uncontrolled thyroid disease.
  • Condition, which in the opinion of the investigator, would interfere with patient safety

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105

Other trials in United States

Israel1 site

  • Schneider Children's Medical Center of Israel

    Petah Tikva

Other trials in Israel

About this study

Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric model predictive control can be developed and evaluated safely in patients with Type 1 Diabetes Mellitus (T1DM) to control blood glucose concentrations.

This study seeks to combine real-time continuous glucose sensing with automated insulin delivery in a closed-loop system that will achieve euglycemia in patients with T1DM. The end result of this line of research will be an artificial pancreas that will provide around-the-clock glucose regulation through controlled insulin delivery in response to detected patterns of change in glucose levels.

Read the detailed description

The goal of the JDRF Artificial Pancreas Project is to produce an autonomous artificial pancreas that can safely and effectively regulate glycemia in people with type 1 diabetes mellitus. In our work, this fully automated closed-loop system combines a subcutaneous continuous glucose monitor (CGM) and a continuous subcutaneous insulin infusion (CSII) pump with a sophisticated control algorithm. This is a proof-of-concept study to demonstrate that the controller could bring the patient back to a relatively normal glucose concentration after an unannounced meal and from mild hyperglycemia. Once the system is initiated, all insulin delivery is calculated automatically. There was no outside intervention either by the subject or medical personnel. An artificial pancreas system that aims at replicating normal beta-cell function by using the subcutaneous-subcutaneous (sc-sc) route needs to address inherent delays in both glucose sensing and insulin delivery. Our strategic approach is that a closed-loop system should operate safely without any knowledge of meals or other disturbances. We have developed the Artificial Pancreas System (APS©) and used it to clinically evaluate a control strategy that allows efficient glycemic control without any a priori meal information. The Artificial Pancreas device uses the Artificial Pancreas System (APS©) platform with the OmniPod insulin pump, the DexCom SEVEN PLUS CGM and a multi-parametric model predictive control algorithm (mpMPC) with an insulin-on-board (IOB) safety constraint.

Being tested
Closed-loop session
Keywords
Diabetes Mellitus, Closed Loop, Artificial Pancreas
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

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

  • Closed-loop sessionDevice

    Also called Closed-loop Artificial Pancreas Device

    Subjects will arrive fasting at 7am unless needed for hypoglycemia (glucose < 70 mg/dL) and no extra bolus insulin after 3am. An IV catheter will be inserted for blood samples and for IV administration of glucose if necessary. Blood samples will be analyzed for glucose by YSI 2300Stat every 30 minutes.

    Breakfast consisting of 25g of CHO will be eaten at 7:30 am and the subject will bolus for this amount of CHO. The controller is switched "on" on the down slope of the meal response, and the subject is brought to a basal steady-state by the controller. Target blood glucose is 110 ± 30-mg/dL.

    After approximately 3 hours a small lunch will be eaten consisting of 25g of CHO (unannounced meal challenge). The subject will be monitored until blood glucose returns to euglycemia.

Study groups in NCT01484457
Study groupRoleWhat they receive
Closed-loop control systemExperimentalThe objective of this study is to automate glucose control in subjects with type 1 diabetes using a computer control algorithm in a controlled in-clinic research setting. The controller will be evaluated under two conditions: 1. restoring euglycemia (80-140 mg/dL) when the controller is initiated during a period when the subject's glucose is above the euglycemic range; 2. restoring euglycemia (80-140 mg/dL) when the controller is challenged with a small unannounced meal (~25 g CHO).
Receives: Device: Closed-loop session

What is being measured

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

  1. Restoration of Euglycemia

    The primary endpoint of this pilot study is successful restoration of euglycemia from the two perturbed conditions using closed loop control with minimal hypo- and hyperglycemia exposure. The first condition involves restoration of euglycemia when the subject is in a hyperglycemic state. The second condition involves restoration of euglycemia following consumption of a meal containing 25g CHO with no insulin bolus. The patients will be followed for the duration of the 12 hour study.

    Measured: 12 hours

Secondary outcomes (1)

  1. Average percent-of-time-in-range (80 - 180 mg/dL)

    All reported blood glucose values per both CGM and YSI ware analyzed for average percent-of-time-in-range (80 - 180 mg/dL). The participants will be followed for the duration of the 12 hour study.

    Measured: 12 hours

Timeline

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

  1. First posted2 Dec 2011 (estimated)
  2. Study startJul 2008
  3. Primary completionJan 2010
  4. Study completionJan 2010

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
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01484457
Sponsor's protocol ID
JDRF 22-2009-796
Status last verified
Mar 2021
First submitted
15 Nov 2011
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Basu R, Di Camillo B, Toffolo G, Basu A, Shah P, Vella A, Rizza R, Cobelli C. Use of a novel triple-tracer approach to assess postprandial glucose metabolism. Am J Physiol Endocrinol Metab. 2003 Jan;284(1):E55-69. doi: 10.1152/ajpendo.00190.2001.

    PubMed 12485809

  • Bellazzi R, Arcelloni M, Bensa G, Blankenfeld H, Brugues E, Carson E, Cobelli C, Cramp D, D'Annunzio G, De Cata P, De Leiva A, Deutsch T, Fratino P, Gazzaruso C, Garcia A, Gergely T, Gomez E, Harvey F, Ferrari P, Hernando E, Boulos MK, Larizza C, Ludekke H, Maran A, Nucci G, Pennati C, Ramat S, Roudsari A, Rigla M, Stefanelli M. Design, methods, and evaluation directions of a multi-access service for the management of diabetes mellitus patients. Diabetes Technol Ther. 2003;5(4):621-9. doi: 10.1089/152091503322250640.

    PubMed 14511417

  • Bellazzi R, Nucci G, Cobelli C. The subcutaneous route to insulin-dependent diabetes therapy. IEEE Eng Med Biol Mag. 2001 Jan-Feb;20(1):54-64. doi: 10.1109/51.897828. No abstract available.

    PubMed 11211661

  • Bequette BW. A critical assessment of algorithms and challenges in the development of a closed-loop artificial pancreas. Diabetes Technol Ther. 2005 Feb;7(1):28-47. doi: 10.1089/dia.2005.7.28.

    PubMed 15738702

  • Bevier WC, Zisser H, Palerm CC, Finan DA, Seborg DE, Doyle FJ, Wollitzer AO, Jovanovic L. Calculating the insulin to carbohydrate ratio using the hyperinsulinaemic-euglycaemic clamp-a novel use for a proven technique. Diabetes Metab Res Rev. 2007 Sep;23(6):472-8. doi: 10.1002/dmrr.727.

    PubMed 17315240

  • Bode BW. Clinical utility of the continuous glucose monitoring system. Diabetes Technol Ther. 2000;2 Suppl 1:S35-41. doi: 10.1089/15209150050214104. No abstract available.

    PubMed 11469630

  • Bode BW, Gross TM, Thornton KR, Mastrototaro JJ. Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. Diabetes Res Clin Pract. 1999 Dec;46(3):183-90. doi: 10.1016/s0168-8227(99)00113-8.

    PubMed 10624783

  • Bode BW, Hirsch IB. Using the continuous glucose monitoring system to improve the management of type 1 diabetes. Diabetes Technol Ther. 2000;2 Suppl 1:S43-8. doi: 10.1089/15209150050214113. No abstract available.

    PubMed 11469631

  • Broekhuyse HM, Nelson JD, Zinman B, Albisser AM. Comparison of algorithms for the closed-loop control of blood glucose using the artificial beta cell. IEEE Trans Biomed Eng. 1981 Oct;28(10):678-87. doi: 10.1109/tbme.1981.324661. No abstract available.

    PubMed 7033107

  • Chanoch LH, Jovanovic L, Peterson CM. The evaluation of a pocket computer as an aid to insulin dose determination by patients. Diabetes Care. 1985 Mar-Apr;8(2):172-6. doi: 10.2337/diacare.8.2.172.

    PubMed 3838930

  • Dalla Man C, Caumo A, Basu R, Rizza R, Toffolo G, Cobelli C. Measurement of selective effect of insulin on glucose disposal from labeled glucose oral test minimal model. Am J Physiol Endocrinol Metab. 2005 Nov;289(5):E909-14. doi: 10.1152/ajpendo.00299.2004. Epub 2005 Jun 21.

    PubMed 15972269

  • Dassau E, Palerm CC, Zisser H, Buckingham BA, Jovanovic L, Doyle FJ. In silico evaluation platform for artificial pancreatic beta-cell development--a dynamic simulator for closed-loop control with hardware-in-the-loop. Diabetes Technol Ther. 2009 Mar;11(3):187-94. doi: 10.1089/dia.2008.0055.

    PubMed 19191486

  • Dassau E, Zisser H, C Palerm C, A Buckingham B, Jovanovic L, J Doyle F 3rd. Modular artificial beta-cell system: a prototype for clinical research. J Diabetes Sci Technol. 2008 Sep;2(5):863-72. doi: 10.1177/193229680800200518.

    PubMed 19885271

  • Diabetes Research in Children Network (DirecNet) Study Group; Buckingham B, Beck RW, Tamborlane WV, Xing D, Kollman C, Fiallo-Scharer R, Mauras N, Ruedy KJ, Tansey M, Weinzimer SA, Wysocki T. Continuous glucose monitoring in children with type 1 diabetes. J Pediatr. 2007 Oct;151(4):388-93, 393.e1-2. doi: 10.1016/j.jpeds.2007.03.047. Epub 2007 Aug 24.

    PubMed 17889075

  • Dua P, Doyle FJ 3rd, Pistikopoulos EN. Model-based blood glucose control for Type 1 diabetes via parametric programming. IEEE Trans Biomed Eng. 2006 Aug;53(8):1478-91. doi: 10.1109/TBME.2006.878075.

    PubMed 16916082

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Closed-loop session in people with Diabetes Mellitus, Type 1, run by Sansum Diabetes Research Institute at 2 sites in 2 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 5 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 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Israel. 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?

Restoration of Euglycemia (time frame: 12 hours). 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 NCT01484457, which also lists 50 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 23 Mar 2021.

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