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Type 1 Diabetes MellitusPhase 3NCT02705053

At Home Study of a Zone-Model Predictive Control (MPC) Controller and a Health Monitoring System (HMS) With the Diabetes Assistant (DiAs) System and Run-to-Run Adaptation

A Phase 3 study testing CGM and Insulin Pump in people with Type 1 Diabetes Mellitus, run by Sansum Diabetes Research Institute at 3 sites 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

This clinical trial is a study to assess the performance of an automated glucose control system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes. 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?
CGM and Insulin Pump
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
3 sitesUnited States
Study dates
Feb 2016to Aug 2016
Phase
Phase 3
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, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year and an insulin pump for at least 6 months
  • Willing to wear the study CGM device for the duration of the study
  • Age ≥21 to <65 years
  • HbA1c <10.0%; if HbA1c <6.0% then total daily insulin must be ≥0.5 U/kg
  • For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
  • Demonstration of proper mental status and cognition for the study
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  • Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes
  • Hypoglycemia awareness as demonstrated by a Clarke Hypoglycemia Unawareness score of 2 or lower
  • Access to internet and cell phone service at home, and a computer for downloading device data
  • Availability of care partner committed to participating in training activities, knowledgeable at all times of the participant's location, and being available to provide assistance when system is being used at night
  • Commitment to maintaining uninterrupted availability via cell phone and avoiding any overnight travel for the duration the period using the closed-loop system
  • An understanding of and willingness to follow the protocol and sign the informed consent

Who cannot join

  • Admission for diabetic ketoacidosis in the 12 months prior to enrollment
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
  • History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
  • Coronary artery disease or heart failure, unless written clearance is received from a cardiologist
  • History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
  • Cystic fibrosis
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  • 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 function test results (Transaminase >2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
  • Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty
  • 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 (TSH undetectable or >10 mlU/L); testing required within three months prior to admission for subjects with a goiter or who are on thyroid hormone replacement, and within one year otherwise
  • Abuse of alcohol or recreational drugs
  • Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)
  • 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 protocol
  • Current use of the following drugs and supplements:
  • Acetaminophen
  • Beta blockers
  • Oral or injectable glucocorticoids
  • Any other medication that the investigator believes is a contraindication to the subject's participation

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • William Sansum Diabetes Center

    Santa Barbara, California, 93111

Other trials in United States

About this study

This clinical trial is a study to assess the performance of an automated glucose control system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes. Specifically, the investigators will test zone model predictive control AP that will be enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios (CR).

Read the detailed description

This clinical trial is a study to assess the performance of an automated glucose control system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes. Specifically, the investigators will test zone model predictive control AP that will be enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios (CR). This protocol builds on the investigators previously validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTrials.gov: NCT01929798) integrated into the Diabetes Assistant (DiAs) system (ClinicalTrials.gov: NCT02463682). The same AP system used in NCT02463682 will now be used with algorithmic adjustment of CR's prior to closed-loop initiation, and continued BR and CR algorithmic optimization during closed-loop use for a longer duration.

The system will be evaluated on up to 12 subjects per site (n=36 subjects) for 15 weeks at 3 different sites (William Sansum Diabetes Center, University of Virginia, and Mayo Clinic, Rochester, MN).

Being tested
CGM and Insulin Pump, Closed-Loop Control System
Keywords
Diabetes Mellitus, Type 1, Artificial Pancreas, Autoimmune Diseases, Diabetes Mellitus, Hyperglycemia, Hypoglycemia
Medical subject headings
Diabetes Mellitus, Type 1, Autoimmune Diseases, Diabetes Mellitus, Hyperglycemia, Hypoglycemia

What participants receive

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

  • CGM and Insulin PumpDevice

    Dexcom G4 Platinum CGM with Share AP Receiver Roche Accu-Chek insulin pump.

  • Closed-Loop Control SystemDevice

    The devices that will be used in the Closed-Loop Control System include the following components:

    DiAs - a smart-phone medical platform; Dexcom G4 Platinum connected to DiAs via Bluetooth CGM receiver; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Zone-MPC and HMS algorithms running on DiAs (MPC and HMS)

Study groups in NCT02705053
Study groupRoleWhat they receive
Sensor-Augmented Pump Open-Loop Care (Week 2)Active comparatorThe subjects' Sensor-Augmented Pump Open-Loop Care for the second week of the study before any adjustments to pump settings, using a CGM and Insulin Pump.
Receives: Device: CGM and Insulin Pump
Closed-Loop Control System with Zone MPC and HMSExperimentalThe artificial pancreas system will be allowed to employ its Model Predictive Control algorithm to make decisions about insulin delivery based on CGM glucose levels. The Health Monitoring System algorithm uses the same CGM data as the MPC control algorithm but utilizes a separate algorithm for trending and predictions of future glucose values. Using a redundant and independent algorithm is an important safety feature of the overall AP device. Algorithmic adjustment of carbohydrate ratios prior to closed-loop initiation, and continued basal rate and carbohydrate ratio algorithmic optimization during closed-loop use will occur.
Receives: Device: Closed-Loop Control System

What is being measured

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

  1. Change in Hemoglobin A1c (HbA1c) (%) from baseline (week 2) to end of week 15 (end of study), with A1c measured at weeks 7 and 11 as well for repeated measures.

    The primary endpoint is change in HbA1c from baseline (end of week 2) to end of week 15 (end of study). HbA1c will be measured at weeks 7 and 11 as well following each adaptation period, so the overall design of the study includes 4 repeated measures and a baseline-end of study contrast.

    Measured: 13 Weeks

Secondary outcomes (10)

  1. Time within the target range for glucose 70-180 mg/dl overall

    Time within the target range for glucose 70-180 mg/dl overall, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.

    Measured: 1 week

  2. Time within the tight target range for glucose 80-140 mg/dl overnight

    Time within the tight target range for glucose 80-140 mg/dl overnight, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.

    Measured: 1 week

  3. Time within the target range for glucose 70-150 mg/dl postprandial within 5 hours following meals

    Time within the target range for glucose 70-150 mg/dl postprandial within 5 hours following meals, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.

    Measured: 1 week

  4. Markers of hypo- and hyperglycemia

    Markers of hypo- and hyperglycemia, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use. These markers include LBGI (Low blood glucose index) and HBGI (High blood glucose index.

    Measured: 1 week

  5. Insulin Doses Given

    Change in insulin doses given, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.

    Measured: 1 week

  6. Treatments for hypoglycemia

    Treatments for hypoglycemia between the open and closed-loop phases of the study, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.

    Measured: 1 week

  7. Number of alerts given by the HMS to prevent hypoglycemia

    Number of alerts given by the HMS to prevent hypoglycemia during closed-Loop control.

    Measured: 12 weeks

  8. Outside interventions needed.

    Outside interventions needed to aid with treatment during closed-Loop control.

    Measured: 12 weeks

  9. Failure analysis of the devices/connectivity issues that may occur (# disconnects and device restarts).

    Failure analysis of the devices/connectivity issues that may occur during closed-Loop control. This includes number of CGM communication losses with 3 or more missed points, and number of times the entire system required a restart

    Measured: 12 weeks

  10. Time with glucose ≤ 70 mg/dL, overall

    Time with glucose ≤ 70 mg/dL, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.

    Measured: 1 week

Timeline

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

  1. First posted10 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionAug 2016
  4. Study completionAug 2016

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02705053
Sponsor's protocol ID
G150063_2
Status last verified
Oct 2016
First submitted
25 Feb 2016
Last updated
14 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Dassau E, Pinsker JE, Kudva YC, Brown SA, Gondhalekar R, Dalla Man C, Patek S, Schiavon M, Dadlani V, Dasanayake I, Church MM, Carter RE, Bevier WC, Huyett LM, Hughes J, Anderson S, Lv D, Schertz E, Emory E, McCrady-Spitzer SK, Jean T, Bradley PK, Hinshaw L, Laguna Sanz AJ, Basu A, Kovatchev B, Cobelli C, Doyle FJ 3rd. Twelve-Week 24/7 Ambulatory Artificial Pancreas With Weekly Adaptation of Insulin Delivery Settings: Effect on Hemoglobin A1c and Hypoglycemia. Diabetes Care. 2017 Dec;40(12):1719-1726. doi: 10.2337/dc17-1188. Epub 2017 Oct 13.

    PubMed 29030383

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CGM and Insulin Pump in people with Type 1 Diabetes Mellitus, run by Sansum Diabetes Research Institute at 3 sites 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 12 inclusion and 22 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change in Hemoglobin A1c (HbA1c) (%) from baseline (week 2) to end of week 15 (end of study), with A1c measured at weeks 7 and 11 as well for repeated measures. (time frame: 13 Weeks). 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 NCT02705053, 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 14 Oct 2016.

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