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In Clinic Evaluation of the PLGM Feature (PLGM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT02130284
First received: April 18, 2014
Last updated: September 3, 2015
Last verified: September 2015
  Purpose
This study is a multi-center, single arm and in-clinic study to evaluate the safety of the PLGM System and its algorithm with the Enlite 3 Sensor.

Condition Intervention Phase
Type 1 Diabetes
Device: Predictive Low Glucose Management Feature in Insulin pump
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In-Clinic Evaluation of the Predictive Low Glucose Management (PLGM) System in Adult and Pediatric Insulin Requiring Patients With Diabetes Using the Enlite 3 Sensor

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • Serious Adverse Events (SAE) [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
    Evaluation of incidence of SAE during in-clinic procedures

  • Unanticipated Device Effect (UADE) [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
    Evaluation of incidence of UADE during in-clinic procedures

  • Severe Hypoglycemia [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
    Evaluation of incidence of severe hypoglycemia during in-clinic procedures

  • Diabetic Ketoacidosis [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
    Evaluation of DKA during in-clinic procedures

  • Rescue Events during in-clinic procedues [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]

Other Outcome Measures:
  • PLGM Performance - Hypoglycemia prevention [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
    Success rate of prevention of hypoglycemia (i.e. 1 - percent of PLGM experiments that have 2 or more consecutive reference glucose values of <= 65 mg/dL)

  • PLGM Performance - Hypoglycemia event rate [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
    Hypoglycemic event rate stratified by PLGM activation and Age

  • PLGM Performance - • Glucose value (YSI) and rate of change over 0.5-2 hours after PLGM activation [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
  • PLGM Performance - Glucose value (YSI) and rate of change over 4 hours after resumption of insulin, which occurs after PLGM activation [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
  • PLGM Performance - Length of PLGM activation [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
  • PLGM Performance - Timing difference between PLGM insulin suspend and YSI reaching 85 mg/dl [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
  • Sensor Performance [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
    Accuracy (MARD%, BIAS)

  • Device Metric / Performance - Summary of Hypoglycemic induction Procedure and its outcomes [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
  • Device Metric / Performance - Glucose (YSI) profile throughout the experiment with and without PLGM activation [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
  • Device Metric/Performance - All device deficiencies [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
  • Subject Disposition - Number of subjects screened, enrolled, repeated, drop-out and complete the study [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
  • Subject Disposition - Terminations [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
    Number of times the study was terminated for low (YSI less than 60 mg/dL) or high (YSI greater than 400 mg/dL or greater than 250 with blood ketone level greater than 1.5 mmol/L) blood glucose

  • Subject Disposition - Duration of in-clinic procedures by subject [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]
  • Baseline Characteristics and Demographic information [ Time Frame: At time of subject enrollment ]
    Age Gender Ethnicity BMI Baseline A1C Duration of diabetes CGM experience


Enrollment: 76
Study Start Date: October 2014
Study Completion Date: September 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Predictive Low Glucose Management (PLGM)
To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Device: Predictive Low Glucose Management Feature in Insulin pump
All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.
Other Name: Medtronic MiniMed 640G Insulin Pump, MMT-1512

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is 14-75 years of age at time of screening
  2. Subject has a clinical diagnosis of type 1 diabetes, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis

    Inclusion Criteria that are Based on Demands of In-Clinic Study Procedures

  3. On pump therapy at the time of screening with insulin sensitivity and insulin carbohydrate ratio
  4. Adequate venous access as assessed by investigator or appropriate staff

Exclusion Criteria:

Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures

  1. Subject is unable to tolerate tape adhesive in the area of sensor placement
  2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
  3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
  4. Subject has a positive urine or serum pregnancy screening test
  5. Subject is female, sexually active without use of contraception and plans to become pregnant during the course of the study
  6. Subject has had a hypoglycemic induced seizure within the past 6 months prior to screening visit
  7. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
  8. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
  9. Subject has a history of a seizure disorder
  10. Subject has central nervous system or cardiac disorder resulting in syncope
  11. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
  12. Subjects with hematocrit (Hct) lower than the normal reference range for age per local lab testing
  13. Subjects with a history or findings on screening electrocardiogram (EKG) of any cardiac arrhythmia, including atrial arrhythmias
  14. Subjects with a history of adrenal insufficiency
  15. Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment
  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: NCT02130284

Locations
United States, California
AMCR Institute, Inc.
Escondido, California, United States, 92026
Stanford University Department of Pediatric Endocrinology
Stanford, California, United States, 94305
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Colorado
Barbara Davis Center of Childhood Diabetes
Denver, Colorado, United States, 80045
United States, Connecticut
Yale University Diabetes Research Program
New Haven, Connecticut, United States, 06519
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
United States, Virginia
University of Virgina
Charlottesville, Virginia, United States, 22903
United States, Washington
Rainier Clinical Research
Renton, Washington, United States, 98057
Sponsors and Collaborators
Medtronic Diabetes
Investigators
Study Director: Scott Lee, MD Medtronic Diabetes
  More Information

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02130284     History of Changes
Other Study ID Numbers: CEP 272 PLGM
Study First Received: April 18, 2014
Last Updated: September 3, 2015

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 28, 2017