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A Crossover Study Comparing Two Automated Insulin Delivery System Algorithms in Adolescents and Young Adults With Type 1 Diabetes

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified February 2017 by HealthPartners Institute
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Medtronic
University of Minnesota - Clinical and Translational Science Institute
Jaeb Center for Health Research
Schneider Children's Medical Center, Israel
Hannover Medical School
University of Ljubljana
Yale University
Joslin Diabetes Center
University of Florida
Stanford University
Food and Drug Administration (FDA)
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT03040414
First received: January 31, 2017
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
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 but do so 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 up or down in an attempt to keep glucose levels in a more optimal range. These systems are called hybrid closed loop meaning while much of the insulin delivery is automated 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 hybrid closed loop systems in adolescents and adults with type 1 diabetes are very encouraging. This study will compare the FDA-approved hybrid closed loop system by Medtronic (670G) to a next-generation Medtronic system programmed to further improve glucose control, particularly around mealtime, which is currently one of the biggest challenges with all hybrid closed loop systems. One hundred adolescents and young adults (ages 14-30) will test each system for three months in a crossover fashion. The investigators will compare how effective each hybrid closed loop system is at preventing high blood glucose readings during day. The investigators will also evaluate the safety of each system and how participants adjust to the daily use of the technology.

Condition Intervention
Type 1 Diabetes Mellitus Device: Medtronic 670G hybrid closed loop system Device: Medtronic 690G hybrid closed loop system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Random assignment in a 1:1 ratio to PID AID system versus PID + Fuzzy Logic AID system for 12 weeks, then a 4-week washout period and then to crossover to the opposite arm for 12 weeks.
Masking: None (Open Label)
Masking Description:
Open label
Primary Purpose: Treatment
Official Title: A Crossover Study Comparing Two Automated Insulin Delivery System Algorithms (PID vs. PID + Fuzzy Logic) in Adolescents and Young Adults With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute:

Primary Outcome Measures:
  • Percent of time continuous glucose monitor (CGM) readings are greater than 180mg/dL from 7am-11pm [ Time Frame: 12 weeks for each arm of the crossover ]
    CGM readings from Medtronic Enlite 3 sensor


Secondary Outcome Measures:
  • Time spent in target glucose range 70-180mg/dL [ Time Frame: 12 weeks for each arm of the crossover ]
    Glucose levels based on sensor glucose data

  • Time spent below target glucose range 70mg/dL [ Time Frame: 12 weeks for each arm of the crossover ]
    Glucose levels based on sensor glucose data

  • Time spent below target glucose range 60mg/dL [ Time Frame: 12 weeks for each arm of the crossover ]
    Glucose levels based on sensor glucose data

  • Time spent below target glucose range 50mg/dL [ Time Frame: 12 weeks for each arm of the crossover ]
    Glucose levels based on sensor glucose data

  • Time spent above target glucose range 180mg/dL [ Time Frame: 12 weeks for each arm of the crossover ]
    Glucose levels based on sensor glucose data

  • Time spent above target glucose range 250mg/dL [ Time Frame: 12 weeks for each arm of the crossover ]
    Glucose levels based on sensor glucose data

  • Time spent above target glucose range 300mg/dL [ Time Frame: 12 weeks for each arm of the crossover ]
    Glucose levels based on sensor glucose data

  • Mean CGM glucose [ Time Frame: 12 weeks for each arm of the crossover ]
    Glucose levels based on sensor glucose data

  • Coefficient of variation [ Time Frame: 12 weeks for each arm of the crossover ]
    Based on sensor glucose data

  • HbA1c [ Time Frame: Baseline and 12 weeks for each arm of the crossover ]
    Central lab glycated hemoglobin


Other Outcome Measures:
  • Severe hypoglycemia rate [ Time Frame: 12 weeks for each arm of the crossover ]
    Hypoglycemia requiring assistance by another individual

  • Diabetic Ketoacidosis (DKA) rate [ Time Frame: 12 weeks for each arm of the crossover ]
    Clinical and laboratory ketoacidosis

  • Quality of life questionnaire [ Time Frame: Baseline and 12 weeks for each arm of the crossover ]
    Standardized quality of life instrument

  • Diabetes technology attitudes questionnaire [ Time Frame: Baseline and 12 weeks for each arm of the crossover ]
    Standardized diabetes technology attitudes instrument


Estimated Enrollment: 112
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: June 29, 2020
Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PID Algorithm
Participants will use the Medtronic 670G hybrid closed loop system using a PID algorithm.
Device: Medtronic 670G hybrid closed loop system
The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and continuous glucose monitor (CGM).
Experimental: PID + Fuzzy Logic Algorithm
Participants will use the Medtronic hybrid closed loop system using Fuzzy Logic + PID algorithm.
Device: Medtronic 690G hybrid closed loop system
The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and continuous glucose monitor (CGM).

Detailed Description:

Seven clinical sites (4 in the US and 3 in Europe) will enroll patients with type 1 diabetes (T1D), ages 14 to less than 30 years old, who have an HbA1c from 7-12% and are using multiple daily injections of insulin (with or without continuous glucose monitoring -CGM) or are using and insulin pump (with or without CGM). Participants may not be currently using the Medtronic 670G system. All patients will be assessed for their QOL and attitudes about the use diabetes management technology.

  • Patients glucose control on their current insulin treatment regimen will be assessed for 2 weeks using blinded CGM (CGM they cannot see the glucose reading on).
  • Then all participants will be started on the same insulin pump (Medtronic 670G) and the pump standard insulin delivery settings will be adjusted.
  • Next all participants will start an Enlite 3 continuous glucose sensor and be instructed on its use and further adjustments to the insulin pump settings will be made using this CGM information. The pump remains in the usual manual mode or open loop mode of operation at this time.
  • All patients will then be randomized to start hybrid closed loop therapy using one of two systems for 12 weeks. They will either use the 670G pump (which uses an algorithm called PID to adjust insulin delivery based on the Enlite 3 CGM data) in open loop or auto mode for 3 months or they will use a different Medtronic Pump very similar in nature the 670G but this has a slightly different algorithm called PID + Fuzzy Logic) to adjust insulin delivery based on the Enlite 3 CGM data in open loop or auto mode for 3 months. Glucose control, adjustment to the technology and the safety of the technology will all be carefully evaluated over this 3 month period with the participants at home, school or work undergoing their usual activities. They will have regular contact with the study team and will intermittently share their ongoing CGM glucose data with the study team at a clinic visit or by uploading their glucose and insulin data to the cloud so it can viewed in a secure fashion by the study team.
  • At the end of 3 months each participant will go back on the 670 G and the CGM system in manual mode or open loop for one month. This is called the washout period.
  • Then all participants will switch to or crossover to the hybrid closed system they were not on originally and use this new hybrid closed loop system in closed loop or auto mode for 3 months as above.
  • At the end of each 3 month period on either the 670G system using the PID algorithm or the new hybrid closed loop system using the PID + Fuzzy Logic algorithm participants will rate their QOL and their adjustment to and attitude toward the hybrid closed loop system they are using.
  • A careful analysis of the all measures of glucose control based on the CGM data for each 3 month period for each hybrid closed loop system will be collected and compared. In addition system safety data will be collected as will all medical events during the study.

After each participant has completed 3 months on each hybrid closed loop system the investigators will be able to compare the effectiveness, safety and patient preference regarding each system.

  Eligibility

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 with duration of at least one year.
  2. Multiple daily injections of insulin or an insulin pump user
  3. HbA1c 7.0%-12.0%
  4. Willingness or ability to do carbohydrate counting
  5. In the investigator's judgment, able to understand and likely to be adherent to the protocol
  6. For subjects <18 years old, living with one or more parent/legal guardian 7. Have internet access and a computer system that meets requirements for uploading data

Exclusion Criteria:

  1. Concomitant disease that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency)
  2. Other medical condition which, in the Investigator's opinion, may compromise patient safety, affect outcome assessments, or affect the subject's ability to follow the protocol.
  3. Oral or parenteral glucocorticoids taken within 1 month prior to enrollment, or plans to take oral or parenteral glucocorticoids within the planned study duration.
  4. Use of antidiabetic agents other than insulin
  5. Use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  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. Female subject of child-bearing potential who has a positive pregnancy test at screening, is pregnant, breast-feeding, or planning to become pregnant within the planned study duration (or is not using adequate contraceptive methods)
  9. Current eating disorder such as anorexia or bulimia
  10. One or more episodes of ketoacidosis requiring hospitalization within 6 months prior to screening
  11. Clinically significant nephropathy (eGFR <30 ml/min) or receiving dialysis
  12. Untreated thyroid disease
  13. Working a night shift
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03040414

Contacts
Contact: Richard Bergenstal, MD 952-993-1913 richard.bergenstal@parknicollet.com
Contact: Mary Johnson, RN, BS, CDE 952-993-1966 mary.l.johnson@parknicollet.com

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Desmond Schatz, MD         
Principal Investigator: Desmond Schatz, MD         
United States, Massachusetts
Joslin Diabetes Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Lori Laffel, MD         
Principal Investigator: Lori Laffel, MD         
United States, Minnesota
International Diabetes Center Not yet recruiting
St. Louis Park, Minnesota, United States, 55416
Contact: Richard Bergenstal, MD         
Principal Investigator: Amy Criego, MD         
Principal Investigator: Anders Carlson, MD         
Germany
Hannover Medical School Not yet recruiting
Hannover, Germany, 30173
Contact: Thomas Danne, MD         
Principal Investigator: Thomas Danne, MD         
Israel
Schneider Children's Medical Center of Israel Not yet recruiting
Petah Tikva, Israel, 4920235
Contact: Moshe Philip, MD         
Principal Investigator: Revital Nimri, MD         
Slovenia
University of Ljubljana Not yet recruiting
Ljubljana, Slovenia
Contact: Tadej Battelino, MD         
Principal Investigator: Tadej Battelino, MD         
Sponsors and Collaborators
HealthPartners Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Medtronic
University of Minnesota - Clinical and Translational Science Institute
Jaeb Center for Health Research
Schneider Children's Medical Center, Israel
Hannover Medical School
University of Ljubljana
Yale University
Joslin Diabetes Center
University of Florida
Stanford University
Food and Drug Administration (FDA)
International Diabetes Center at Park Nicollet
  More Information

Publications:

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03040414     History of Changes
Other Study ID Numbers: UC4DK108611 ( U.S. NIH Grant/Contract )
Study First Received: January 31, 2017
Last Updated: February 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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 HealthPartners Institute:
Hybrid closed loop
Closed loop
Artificial pancreas

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

ClinicalTrials.gov processed this record on September 21, 2017