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In Clinic Evaluation of the PLGM Feature (PLGM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02130284
First Posted: May 5, 2014
Last Update Posted: September 28, 2017
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.
Information provided by (Responsible Party):
Medtronic Diabetes
  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
Type 1 Diabetes Device: Predictive Low Glucose Management Feature in Insulin pump

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Event Rate at Threshold of YSI <= 65 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 ]
    Hypoglycemic event rate among 71 subjects who underwent the PLGM experiment. Hypoglycemic events are defined based on: occurrence of 2 or more continuous YSI <= 65 mg/dL during in-clinic procedures.

  • Sensor Performance: Accuracy [ 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 ]
    MARD (Mean Absolute Relative Difference) between sensor glucose value and YSI. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100).

  • 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 ]

Enrollment: 80
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

  Hide Detailed Description

Detailed Description:

A total of up to 95 subjects with type 1 diabetes (age 14-75 years old) will be enrolled at up to 8 investigational centers in order to reach a minimum of 60 subjects who will complete the study (N=minimum 40 adult subjects, 22-75 years old) and N=minimum 15 pediatric subjects (14-21 years old). Subjects will be evaluated in an in-clinic setting with induction of hypoglycemia by increasing their basal rate using a standardized titration tool referred to in protocol as rate of change basal increase algorithm (Buckingham, Diabetes Care 5, 2010). Total duration of frequent sample testing (FST) using Yellow Springs Instrument (YSI) may be up to 19 hours.

Subjects will undergo in-clinic testing on Sensor Day 1.

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.

The In-Clinic part of the study consists of hypoglycemic induction and an observation period.

Hypoglycemic induction ends when one of the following 3 criteria is met, whichever comes first:

  1. PLGM is activated
  2. YSI glucose is less than or equal to 65 mg/dL, followed by the next YSI sample less than or equal to 65 mg/dL (2 contiguous YSI samples).
  3. Neither condition for #1 or #2 has been met in 12 hours

Observation with YSI ends when:

  1. If PLGM is activated, observation with YSI frequent sample testing will include the Suspend period (30 minutes minimum to 2 hours maximum) and insulin resumption period (approximately 4 hours from the time insulin delivery resumes). This may include insulin re-suspension during this period. Maximum observation with YSI frequent sample testing should be no longer than 19 hours.
  2. YSI glucose less than or equal to 65 mg/dL is followed by the next YSI sample less than or equal to 65 mg/dL (2 contiguous YSI samples). The subject will be rescued and YSI observation will end
  3. Twelve hours have passed since the start of hypoglycemic induction without PLGM activation
  4. See In-Clinic Stopping rules

Enrollment for this study will proceed in phases.

Phase 1 only allows enrollment of adult subjects (22-75 years). Subjects will wear pump system, as shown below:

  • One Study Pump
  • One GST-3C Transmitter
  • One Enlite 3 Sensor

Progression to Phase 2 may occur after 10 adult subjects have completed Phase 1 and a Data Safety Monitoring Board (DSMB) has approved that it is safe to continue on to Phase 2.

Phase 2 enrollment involves a minimum of 15 pediatric subjects (14-21). Subjects will wear the same pump system as shown for Phase 1.

A total of up to 95 subjects will be enrolled at up to 10 investigational centers in order to reach a minimum of 60 subjects (N=minimum 40 adult subjects and N=minimum 15 pediatric subjects) who will complete the study.

Considering around 15% screen failure rate and approximately 15% drop-out rate, a total of up to 95 subjects will be enrolled in order to have 60 subjects complete the study.

  1. The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American
  2. Subjects will be grouped into cohorts by Age

The study is anticipated to last no longer than 12 months from investigational center initiation to completion of all data entry and monitoring procedures including final report. Subjects can expect to participate for approximately 2-3 weeks.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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): 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
First Submitted: April 18, 2014
First Posted: May 5, 2014
Results First Submitted: February 14, 2017
Results First Posted: April 4, 2017
Last Update Posted: September 28, 2017
Last Verified: August 2017

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