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Type 1 Diabetes MellitusNCT03767790

Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting

A study testing iAPS 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 objective of this randomized crossover clinical trial is to 1) assess the efficacy and safety of an automated insulin delivery (AID) system using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS) in people with type 1 diabetes, and 2) assess… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
iAPS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
3 Jan 2019to 27 Jun 2019
Phase
Interventional
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

  • Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year.
  • Using an insulin pump for at least 3 months at the time of screening. Insulin pump use includes use of automated features, to include predictive or threshold low-glucose suspend or hybrid closed-loop with without a Dexcom sensor.
  • Familiarity and use of a carbohydrate ratio for meal boluses.
  • Age ≥18.0 years old
  • HbA1c < 10.5%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 weeks of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
  • 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 serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
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  • Willingness to switch home pump to PLGS or full manual mode if using hybrid closed-loop with an FDA approved system.
  • Have an emergency contact living at home with the subject who will be available to be contacted by the study staff overnight in the event of an emergency.
  • Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, to include having basic cooking equipment at home to prepare the study meals.
  • Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
  • Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.

Who cannot join

  • Use of an unapproved closed-loop insulin delivery system within 2 weeks before screening or during the study is not allowed.
  • Gastrointestinal disease such as celiac disease or multiple food allergies.
  • Any form of gluten sensitivity or wheat allergy.
  • Allergies to any form of nuts or ingredients present in the study meals (tomatoes etc).
  • History of difficulty digesting food.
  • Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
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  • Hemophilia or any other bleeding disorder
  • One or more episodes of hypoglycemia requiring an emergency room visit or hospitalization in the past 6 months.
  • One or more episodes of hyperglycemia requiring an emergency room visit or hospitalization in the past 6 months.
  • Self-reported or clinically documented hypoglycemia unawareness.
  • A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
  • Participation in another pharmaceutical or device trial at the time of enrollment or during the study
  • Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105

Other trials in United States

About this study

Official title: A Randomized Crossover Comparison of Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting

The objective of this randomized crossover clinical trial is to 1) assess the efficacy and safety of an automated insulin delivery (AID) system using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS) in people with type 1 diabetes, and 2) assess the impact of different meal macronutrient content on glucose control when using AID and SAP.

Read the detailed description

The goal of this study is to compare the efficacy and safety of an AID system using a MPC algorithm versus SAP/PLGS therapy with different food choices over a 4 week period.

The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.

In this study, during each two-week period, subjects will be given pre-weighed portions of different meals to eat (either regular semolina pasta or extra-long grain white rice) with detailed cooking instructions, and will eat these meals on 6 different occasions for dinner. They will bolus as they normally do for these meals. This will allow us to observe the postprandial meal response when using sensor-augmented pump (SAP) or iAPS, showing the importance of nutrition choices with modern technological treatments in T1D.

Being tested
iAPS
Keywords
Artificial Pancreas, Hyperglycemia, Hypoglycemia, Nutrition
Medical subject headings
Diabetes Mellitus, Type 1, Hyperglycemia, Hypoglycemia

What participants receive

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

  • iAPSDevice

    The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.

Study groups in NCT03767790
Study groupRoleWhat they receive
Automated Insulin DeliveryExperimentalParticipants will use the Automated Insulin Delivery (AID) iAPS system for 2 weeks in the outpatient setting. During AID use, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal.
Receives: Device: iAPS
SAP/PLGSNo interventionParticipants will use their home pump with a CGM sensor (sensor augmented pump) or in Predictive Low Glucose Suspend (PLGS) mode if their home pump supports this mode, for 2 weeks in the outpatient setting. During these 2 weeks, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal.

What is being measured

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

  1. Time in target glucose range

    Time in target glucose range 70-180 mg/dL measured by CGM to determine safety and efficacy of the integrated system

    Measured: 4 weeks

Secondary outcomes (12)

  1. Postprandial glucose peak

    Postprandial glucose peak rise (highest measurement in mg/dL) from baseline glucose (mg/dl) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS

    Measured: 4 weeks

  2. Time to postprandial glucose peak

    Time (minutes) to postprandial glucose (highest measurement in mg/dL) rise from baseline glucose (mg/dl) during the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS

    Measured: 4 weeks

  3. Postprandial Area Under the Curve

    Area Under the Curve Glucose (mg/dl x min) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS

    Measured: 4 weeks

  4. Postprandial time for glucose to return to baseline

    Time (minutes) for CGM glucose to return to baseline (starting value) after the study meals, during both use of SAP/PLGS and when using the iAPS

    Measured: 4 weeks

  5. Glucose < 70 mg/dL

    Percent time GGM glucose < 70 mg/dL

    Measured: 4 weeks

  6. Glucose < 54 mg/dL

    Percent time GGM glucose < 54 mg/dL

    Measured: 4 weeks

  7. Glucose > 180 mg/dL

    Percent time GGM glucose > 180 mg/dL

    Measured: 4 weeks

  8. Glucose > 250 mg/dL

    Percent time GGM glucose > 250 mg/dL

    Measured: 4 weeks

  9. Serious adverse events (SAE)

    The total number of serious adverse events during the clinical trial

    Measured: 4 weeks

  10. Serious adverse device events (SADE)

    The total number of serious adverse events related to the study device use during the clinical trial

    Measured: 4 weeks

  11. Adverse device effects (ADE)

    The total number of adverse device effects (ADE) during the clinical trial

    Measured: 4 weeks

  12. Unanticipated adverse device effects (UADE)

    The total number of unanticipated adverse device effects (UADE) during the clinical trial

    Measured: 4 weeks

Timeline

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

  1. First posted7 Dec 2018
  2. Study start3 Jan 2019
  3. Primary completion27 Jun 2019
  4. Study completion27 Jun 2019

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03767790
Sponsor's protocol ID
G180011-S001
Status last verified
Aug 2019
First submitted
5 Dec 2018
Last updated
8 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Deshpande S, Pinsker JE, Church MM, Piper M, Andre C, Massa J, Doyle Iii FJ, Eisenberg DM, Dassau E. Randomized Crossover Comparison of Automated Insulin Delivery Versus Conventional Therapy Using an Unlocked Smartphone with Scheduled Pasta and Rice Meal Challenges in the Outpatient Setting. Diabetes Technol Ther. 2020 Dec;22(12):865-874. doi: 10.1089/dia.2020.0022. Epub 2020 Oct 13.

    PubMed 32319791

Questions about this trial

What is this clinical trial studying?

A study testing iAPS 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 11 inclusion and 13 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 8 Aug 2019. 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.

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 in target glucose range (time frame: 4 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 NCT03767790, 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 8 Aug 2019.

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