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

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ClinicalTrials.gov Identifier: NCT03767790
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborators:
Harvard John A. Paulson School of Engineering and Applied Sciences
Harvard School of Public Health
Information provided by (Responsible Party):
Sansum Diabetes Research Institute

Brief 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 the impact of different meal macronutrient content on glucose control when using AID and SAP.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: iAPS Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 3, 2019
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Automated Insulin Delivery
Participants 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.
Device: iAPS
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.

No Intervention: SAP/PLGS
Participants 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.



Primary Outcome Measures :
  1. Time in target glucose range [ Time Frame: 4 weeks ]
    Time in target glucose range 70-180 mg/dL measured by CGM to determine safety and efficacy of the integrated system


Secondary Outcome Measures :
  1. Postprandial glucose peak [ Time Frame: 4 weeks ]
    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

  2. Time to postprandial glucose peak [ Time Frame: 4 weeks ]
    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

  3. Postprandial Area Under the Curve [ Time Frame: 4 weeks ]
    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

  4. Postprandial time for glucose to return to baseline [ Time Frame: 4 weeks ]
    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

  5. Glucose < 70 mg/dL [ Time Frame: 4 weeks ]
    Percent time GGM glucose < 70 mg/dL

  6. Glucose < 54 mg/dL [ Time Frame: 4 weeks ]
    Percent time GGM glucose < 54 mg/dL

  7. Glucose > 180 mg/dL [ Time Frame: 4 weeks ]
    Percent time GGM glucose > 180 mg/dL

  8. Glucose > 250 mg/dL [ Time Frame: 4 weeks ]
    Percent time GGM glucose > 250 mg/dL

  9. Serious adverse events (SAE) [ Time Frame: 4 weeks ]
    The total number of serious adverse events during the clinical trial

  10. Serious adverse device events (SADE) [ Time Frame: 4 weeks ]
    The total number of serious adverse events related to the study device use during the clinical trial

  11. Adverse device effects (ADE) [ Time Frame: 4 weeks ]
    The total number of adverse device effects (ADE) during the clinical trial

  12. Unanticipated adverse device effects (UADE) [ Time Frame: 4 weeks ]
    The total number of unanticipated adverse device effects (UADE) during the clinical trial


Other Outcome Measures:
  1. Total daily insulin use [ Time Frame: 4 weeks ]
    Total daily insulin use (units/day) during both use of SAP/PLGS and when using the iAPS

  2. Total basal insulin use [ Time Frame: 4 weeks ]
    Total daily basal insulin use (units/day) during both use of SAP/PLGS and when using the iAPS

  3. Total bolus insulin use [ Time Frame: 4 weeks ]
    Total daily bolus insulin use (units/day) during both use of SAP/PLGS and when using the iAPS

  4. Sensor Use Time [ Time Frame: 4 weeks ]
    Total hours of CGM sensor use time during both use of SAP/PLGS and when using the iAPS

  5. Closed-Loop Active Time [ Time Frame: 2 weeks ]
    Percent time (hours/day) of closed-loop use during the two weeks of iAPS use

  6. Device Issues [ Time Frame: 4 weeks ]
    Total number of devices issues during the clinical trial



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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).
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767790


Contacts
Contact: Camille Andre 805-682-7640 ext 217 candre@sansum.org

Locations
United States, California
Sansum Diabetes Research Institute Not yet recruiting
Santa Barbara, California, United States, 93105
Contact: Camille Andre    805-682-7640 ext 217    candre@sansum.org   
Principal Investigator: Jordan E Pinsker, MD         
Sub-Investigator: Mei Mei Church, NP         
Sponsors and Collaborators
Sansum Diabetes Research Institute
Harvard John A. Paulson School of Engineering and Applied Sciences
Harvard School of Public Health
Investigators
Principal Investigator: Eyal Dassau, PhD John A. Paulson School of Engineering and Applied Sciences
Principal Investigator: David Eisenberg, MD Harvard T.H. Chan School of Public Health
Principal Investigator: Jordan E Pinsker, MD Sansum Diabetes Research Institute

Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT03767790     History of Changes
Other Study ID Numbers: G180011-S001
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Sansum Diabetes Research Institute:
Artificial Pancreas
Hyperglycemia
Hypoglycemia
Nutrition

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Pancrelipase
Pancreatin
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents