Medtronic Minimed Overnight Closed-Loop System

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University
ClinicalTrials.gov Identifier:
NCT01881009
First received: June 16, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a closely monitored 12 hour overnight inpatient study. Once the safety of the device has been validated we will move the study to an outpatient diabetes camp setting. The camp setting will allow us to obtain pilot efficacy and safety data in a "real-life" environment.

We plan to compare the subject control nights to the subject nights on the OCL system to assess the percent of sensor glucose readings in the target range of 70-150 mg/dl. Based on previous research, we anticipate that the use of the OCL system will contribute to a greater percentage of sensor glucose readings in the target range.


Condition Intervention
Type 1 Diabetes Mellitus
Autoimmune Diabetes
Juvenile-Onset Diabetes
Diabetes, Mellitus, Type 1
Device: ePID Algorithm on an Android Platform with Remote Monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nocturnal Closed-Loop Control Using An ePID Algorithm On An Android Platform With Remote Monitoring In A Closely Monitored Camp Setting: The OCL Camp Study

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Target sensor glucose 70-150 mg/dl [ Time Frame: Approximately 12 hours ] [ Designated as safety issue: Yes ]
    Compared to control nights, the percent of sensor glucose readings in the target range of 70-150 mg/dl.


Secondary Outcome Measures:
  • Percentage of time CGM glucose readings are <70 mg/dl and > 180 mg/dl [ Time Frame: Approximately 12 hours ] [ Designated as safety issue: Yes ]

    Secondary measures of glucose efficacy comparing treatment to control nights:

    1. Percentage of time CGM glucose readings are <70 mg/dl and > 180 mg/dl
    2. Distribution of CGM and meter glucose values overnight. (min, max, median, interquartile ranges, mean, standard deviation)
    3. Hypoglycemia area under the curve (AUC) (CGM glucose less than 60 mg/dL, 70 mg/dL,)
    4. Hyperglycemia AUC (CGM glucose greater than 180 mg/dL, 240 mg/dl)
    5. Incidence of hypoglycemia (meter glucose less than 60 mg/dL, less than 70 mg/dL)


Estimated Enrollment: 46
Study Start Date: June 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Overnight Closed Loop Control (OCL)
Overnight Closed Loop Control with Remote Monitoring using the ePID Algorithm on an Android Platform with Remote Monitoring
Device: ePID Algorithm on an Android Platform with Remote Monitoring
Medtronic Overnight Closed-Loop System: Revel insulin pump, Enlite sensor, Minimed transmitter, ePID algorithm on an Android platform with remote monitoring.
No Intervention: Control Nights
Sensor augmented pump without OCL (overnight closed loop) or remote monitoring

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible for the study, a subject must meet the following criteria:

  • Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and a Medtronic insulin infusion pump for at least 3 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
  • Age 10.0 - 35 years

Exclusion Criteria:

The presence of any of the following is an exclusion for the study:

  • Diabetic ketoacidosis in the past month
  • Hypoglycemic seizure or loss of consciousness in the past 3 months
  • History of seizure disorder (except for hypoglycemic seizure)
  • History of any heart disease including coronary artery disease, heart failure, or arrhythmias
  • Cystic fibrosis
  • Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
  • History of ongoing renal disease (other than microalbuminuria).
  • Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:

    • Inpatient psychiatric treatment in the past 6 months
    • Uncontrolled adrenal disorder
    • Abuse of alcohol
  • Pregnancy
  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: NCT01881009

Contacts
Contact: Paula Clinton, RD, CDE (650) 736-2313 pclinton@stanford.edu
Contact: Satya Shanmugham, BS (650) 736-8142 satyas1@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305-5208
Contact: Paula Clinton, RD, CDE    650-736-2313    pclinton@stanford.edu   
Contact: Satya Shanmugham, BS    (650) 736-8142    satyas1@stanford.edu   
Principal Investigator: Bruce A Buckingham, MD         
Sponsors and Collaborators
Bruce A. Buckingham
Investigators
Principal Investigator: Bruce Buckingham, MD Stanford University
  More Information

No publications provided

Responsible Party: Bruce A. Buckingham, MD, Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT01881009     History of Changes
Other Study ID Numbers: G130115
Study First Received: June 16, 2013
Last Updated: June 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Diabetes
Insulin
Closed loop
Nocturnal glucose control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014