In Clinic Evaluation of the PLGM Feature

NCT02130284 | Completed Results DMC

• 1 other identifier: CEP 272 PLGM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (5)

• Serious Adverse Events (SAE)

  Evaluation of incidence of SAE during in-clinic procedures

  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

• Unanticipated Device Effect (UADE)

  Evaluation of incidence of UADE during in-clinic procedures

  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

• Severe Hypoglycemia

  Evaluation of incidence of severe hypoglycemia during in-clinic procedures

  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

• Diabetic Ketoacidosis

  Evaluation of DKA during in-clinic procedures

  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

• Rescue Events During In-clinic Procedues

  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 Outcomes (3)

• PLGM Performance - Hypoglycemia Event Rate at Threshold of YSI <= 65 mg/dL.

  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: Accuracy

  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

  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

Study Arms (1)

Predictive Low Glucose Management (PLGM)

EXPERIMENTAL

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

Interventions

Predictive Low Glucose Management Feature in Insulin pump DEVICE

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.

Also known as: Medtronic MiniMed 640G Insulin Pump, MMT-1512

Predictive Low Glucose Management (PLGM)

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 14-75 years of age at time of screening
• 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
• On pump therapy at the time of screening with insulin sensitivity and insulin carbohydrate ratio
• Adequate venous access as assessed by investigator or appropriate staff

You may not qualify if:

• Subject is unable to tolerate tape adhesive in the area of sensor placement
• Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
• 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
• Subject has a positive urine or serum pregnancy screening test
• Subject is female, sexually active without use of contraception and plans to become pregnant during the course of the study
• Subject has had a hypoglycemic induced seizure within the past 6 months prior to screening visit
• Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
• Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
• Subject has a history of a seizure disorder
• Subject has central nervous system or cardiac disorder resulting in syncope
• 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
• Subjects with hematocrit (Hct) lower than the normal reference range for age per local lab testing
• Subjects with a history or findings on screening electrocardiogram (EKG) of any cardiac arrhythmia, including atrial arrhythmias
• Subjects with a history of adrenal insufficiency
• Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (8)

AMCR Institute, Inc.

Escondido, California, 92026, United States

Location

Stanford University Department of Pediatric Endocrinology

Stanford, California, 94305, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Barbara Davis Center of Childhood Diabetes

Denver, Colorado, 80045, United States

Location

Yale University Diabetes Research Program

New Haven, Connecticut, 06519, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

University of Virgina

Charlottesville, Virginia, 22903, United States

Location

Rainier Clinical Research

Renton, Washington, 98057, United States

Location

Related Publications (1)

• Buckingham BA, Bailey TS, Christiansen M, Garg S, Weinzimer S, Bode B, Anderson SM, Brazg R, Ly TT, Kaufman FR. Evaluation of a Predictive Low-Glucose Management System In-Clinic. Diabetes Technol Ther. 2017 May;19(5):288-292. doi: 10.1089/dia.2016.0319. Epub 2017 Feb 16.

  PMID: 28221823 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Suiying Huang, Statistician
• Organization: Medtronic Minimed

suiying.huang@medtronic.com

818-576-3319

Study Officials

• Scott Lee, MD

  Medtronic Diabetes

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: May 5, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 28, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-08

Locations

US (8)