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Fuzzy Logic Automated Insulin Regulation (FLAIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040414
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : October 17, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Medtronic
Jaeb Center for Health Research
Schneider Children's Medical Center, Israel
University of Ljubljana
Yale University
Joslin Diabetes Center
University of Florida
Stanford University
International Diabetes Center at Park Nicollet
Kinderkrankenhaus auf der Bult
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
HealthPartners Institute

Brief Summary:

Adolescents and young adults with type 1 diabetes often have a difficult time achieving good glucose control, which is so important in reducing the risk for diabetes complications. Despite the use of multiple daily injections or insulin pumps and glucose sensors, there is still a need for many individuals to further improve glucose levels without causing low blood glucose levels (hypoglycemia) or adding to the daily burden of living with diabetes. Today an insulin pump can receive glucose readings from a continuous glucose monitor and adjust the insulin delivery in an attempt to keep glucose levels in a more optimal range. These systems are called hybrid closed loop (HCL). This means that much of the insulin delivery is automated, yet the patient still interacts regularly with the system, particularly to help determine the insulin dose to deliver to cover a meal. Results of early studies using HCL systems in adolescents and adults with type 1 diabetes are encouraging.

The objective of this study is to compare the efficacy and safety of the automated insulin delivery (AID) system with proportional integral-derivative (PID) algorithm (Minimed 670G 3.0 HCL) to an AID system with combined PID and Fuzzy Logic Algorithm (Minimed 670G 4.0 Advanced Hybrid Closed-Loop (AHCL)). The trial will test the hypothesis that the Minimed AHCL can reduce daytime hyperglycemia, currently the biggest challenge for AID systems, without increasing hypoglycemia.

Up to 124 adolescents and young adults (ages 14-<30) will be recruited to test each system for three months in a randomized crossover trial. Investigators will compare how effective each hybrid closed loop system is at preventing high blood glucose readings during the day. The investigators will also evaluate the safety of each system and how participants adjust to the daily use of the technology.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: MedtronicMinimed 670G 3.0 hybrid closed loop system Device: Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor. Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized crossover trial with two 12-week crossover periods in auto mode preceded by a run-in phase.
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: Home Use of MD-Logic Automated Insulin Delivery System: Safety and Efficacy
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PID Algorithm
Participants will receive insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm..
Device: MedtronicMinimed 670G 3.0 hybrid closed loop system
The components of the intervention are the insulin pump with insulin delivery algorithm (PID).

Experimental: PID + Fuzzy Logic Algorithm
Participants will receive insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.
Device: Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.
The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).




Primary Outcome Measures :
  1. Superiority for percent of time >180 mg/dL (10.0 mmol/L) from 6 AM to 11:59 PM [ Time Frame: 12 weeks for each arm of the crossover ]
    Glucose levels based on sensor glucose data

  2. Non-inferiority for percent of time <54 mg/dL (3.0 mmol/L) during the entire 24-hour period. [ Time Frame: 12 weeks for each arm of the crossover ]
    Glucose levels based on sensor glucose data


Secondary Outcome Measures :
  1. Efficacy: CGM derived indices [ Time Frame: 12 weeks for each arm of the crossover ]
    CGM derived indices over the first 84 days of each treatment period for 24 hours (excluding time before auto mode is turned on) daytime (6 AM-11:59 PM), nighttime (12 AM - 5:59 AM), and for each post-meal period, measured for up to three hours after a meal (or until another carbohydrate is entered).Glucose levels based on sensor glucose data for Mean glucose; coefficient of variation; percentage of sensor glucose readings in the range of 70 to 180 mg/dL (3.9-10.0 mmol/L) and 70 to 140 mg/dL (3.9 to 7.8 mmol/L); percentage of sensor glucose readings >180 mg/dL (daytime is a co-primary outcome) and >250 mg/dL (10.0 and 13.9 mmol/L, respectively); and peak glucose and change in glucose from the start of the meal to the peak (only calculated for post-meal periods)

  2. Efficacy: Amount of total, basal and bolus daily insulin over the first 84 days of each treatment period [ Time Frame: 12 weeks for each arm of the crossover ]
    Amount of total, basal, and bolus daily insulin over the first 84 days of each treatment period (excluding time before auto mode is turned on) for 24 hours, daytime (6 AM-11:59 PM), nightime (12 AM and 5:59 AM), and for each post-meal period, from the time the carbohydrate is entered for up to three hours or until another carbohydrate is entered. Glucose levels based on sensor glucose data

  3. Efficacy: HbA1c [ Time Frame: Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending) ]
    Lab measured

  4. Efficacy: BMI [ Time Frame: Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending) ]
    Height and weight

  5. Key Safety Outcome 1) Percentage of sensor glucose readings <54 mg/dL and <70 mg/dL (3.0 and 3.9 mmol/L, respectively) [ Time Frame: 12 weeks for each arm of the crossover ]
    Glucose levels based on sensor glucose data

  6. Key Safety Outcome 2) DKA events [ Time Frame: 12 weeks for each arm of the crossover ]
    As determined by ketone levels

  7. Key Safety Outcome 3) Severe hypoglycemia events [ Time Frame: 12 weeks for each arm of the crossover ]
    As defined by the Diabetes Control and Complications Trial (DCCT)


Other Outcome Measures:
  1. Amount of total basal and bolus insulin at daytime, nighttime and post-meal, analyzing both total units and units/kg [ Time Frame: 12 weeks for each arm of the crossover ]
    Based on sensor glucose data

  2. Human Factors and Diabetes Technology Attitude and Human Factors questionnaires [ Time Frame: Time Frame: Screening visit, at initiation (Day 0); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending) ]
    Surveys completed by participants



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 1 diabetes mellitus (as diagnosed clinically) for at least one year
  2. Age 14-<30 years at enrollment
  3. For females, not currently known to be pregnant, be breast-feeding or planning to become pregnant within the study duration.
  4. Using an insulin pump or multiple daily injections of insulin

    1. Participant must be able to obtain U-100 rapid acting insulin analogues, Aspart or Lispro, for use during the study (since these are the only insulins approved for the study pump and the study is not supplying insulin)
    2. MDI users must be on a basal/bolus regimen
    3. Participants must have a minimum total daily dose (TDD) of at least eight units
  5. HbA1c from an approved HbA1c point of care analyzer with a value 7.0%-11.0%
  6. Willingness or ability to do carbohydrate counting
  7. In the investigator's judgment, able to understand and likely to be adherent to the protocol
  8. For subjects <18 years old, living with one or more diabetes care partners (eg.g. parent/legal guardian), of whom at least one is committed to participating in study training for emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
  9. Have adequate internet access and a computer system that meets requirements for uploading data.
  10. For participants currently using CGM or insulin pump, willingness to discontinue personal CGM and pump when using the study CGM and pumps (note: including implantable CGMs).

Exclusion Criteria:

Individuals meeting any of the following exclusion criteria at screening will be excluded from study participation:

  1. Concomitant disease that influences metabolic control or HbA1c interpretation (e.g. anemia, significantly impaired hepatic function, confirmed gastroparesis, renal failure, history of adrenal insufficiency, sickle cell disease, haemoglobinopathy, or has received red blood cell transfusion or erythropoietin within three months prior to time of screening) or other medical condition which, in the Investigator's opinion, may compromise patient safety, affect outcome assessments, or affect the participant's ability to follow the protocol
  2. Oral or parenteral glucocorticoids taken within 1 month prior to enrollment, or plans to take oral or parenteral glucocorticoids within the planned study duration. Exceptions: Short term oral or parenteral glucocorticoids up to seven days
  3. Use of antidiabetic agents other than insulin
  4. Use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  5. One or more episodes of severe hypoglycemia (hypoglycemia requiring treatment by another person) within the previous six months
  6. Known allergy to medical grade adhesives
  7. Participation in another study of a medical device or drug that could affect glucose measurements or glucose management or receipt of any investigational medical product within 1 month prior to enrollment
  8. Current eating disorder such as anorexia or bulimia
  9. Currently abusing illicit drugs, marijuana, prescription drugs, or alcohol
  10. Visual impairment or hearing loss, which may compromise the participant's ability to perform all study procedures safely, as determined by the investigator
  11. One or more episodes of diabetic ketoacidosis (DKA) requiring hospitalization within six months prior to screening
  12. Working night shifts
  13. Untreated celiac disease, hyperthyroidism, or hypothyroidism
  14. Clinically significant nephropathy (eGFR <45 mL/min) or on dialysis. Creatinine to determine eGFR must have been obtained as part of usual care within 12 months prior to enrollment (if not available, at time of enrollment, screening can proceed but it must be available prior to randomization)

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): NCT03040414


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
International Diabetes Center
Saint Louis Park, Minnesota, United States, 55416
Germany
Kinderkrankenhaus Auf Der Bult
Hannover, Germany, 30173
Israel
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 4920235
Slovenia
University of Ljubljana
Ljubljana, Slovenia
Sponsors and Collaborators
HealthPartners Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Medtronic
Jaeb Center for Health Research
Schneider Children's Medical Center, Israel
University of Ljubljana
Yale University
Joslin Diabetes Center
University of Florida
Stanford University
International Diabetes Center at Park Nicollet
Kinderkrankenhaus auf der Bult
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Richard Bergenstal, MD International Diabetes Center, HealthPartners Institute
Principal Investigator: Moshe Phillip, MD Schneider Children's Medical Center, Israel

Publications:

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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03040414     History of Changes
Other Study ID Numbers: UC4DK108611 ( U.S. NIH Grant/Contract )
UC4DK108611 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by HealthPartners Institute:
Hybrid closed loop
Closed loop
Artificial pancreas
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs