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Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study

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ClinicalTrials.gov Identifier: NCT00884611
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University

Brief Summary:

This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation.

The purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted in a home setting.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Predictive Low Glucose Suspend Algorithm ON Device: Predictive Low Glucose Suspend Algorithm OFF Not Applicable

Detailed Description:

After the run-in phase, there is a 21-night trial in which each night is randomly assigned 2:1 to have either the predictive low-glucose suspend (PLGS) system active (intervention night) or inactive (control night).

Three predictive algorithm versions were studied sequentially during the study.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Algorithms for a Hypoglycemic Prevention Alarm
Study Start Date : May 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Predictive Low Glucose Suspend
The pump suspension system consists of the Revel CGM device communicating with a laptop computer that contains the hypoglycemia prediction algorithm. During the 21 night study period, the laptop is placed at the bedside and turned on by the participant at bedtime and off on arising in the morning.The laptop contains a randomization schedule (2:1) that indicats whether the hypoglycemia prediction algorithm will be in operation that night (Predictive Low Glucose Suspend Algorithm ON) or will not be activated (Predictive Low Glucose Suspend Algorithm OFF), to which the participant is blinded.
Device: Predictive Low Glucose Suspend Algorithm ON
The algorithm uses a Kalman filter-based model to predict whether the sensor glucose level will fall below 80 mg/dL within a given time period and suspends the insulin pump if this event is predicted.
Other Name: Intervention Night
Device: Predictive Low Glucose Suspend Algorithm OFF
Other Name: Control Night



Primary Outcome Measures :
  1. Percentage of Nights With CGM (Continuous Glucose Monitor) Sensor Values < 60 mg/dL [ Time Frame: 21 days ]
    Nights with CGM sensor values < 60 mg/dL were considered to be undesirable. A Kalman filter-based model algorithm predicted whether the sensor glucose level would fall below 80 mg/dL and would suspend insulin delivery as needed. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.


Secondary Outcome Measures :
  1. Percentage of Nights With CGM Values >180 mg/dL [ Time Frame: 21 days ]
    Nights with CGM sensor values >180 mg/dL were considered to be undesirable. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.

  2. Mean Morning Blood Glucose (BG) [ Time Frame: 21 days ]
    Desirable glucose level was 70-180 mg/mL. Average of all morning BG data is presented. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.



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Ages Eligible for Study:   12 Years to 46 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older,
  2. Type 1 diabetes for at least 1 year
  3. Current user of the MiniMed Paradigm Real-Time Revel system and Sof-sensor glucose sensor
  4. Hemoglobin A1c level of < 8.0%,
  5. Home computer with access to the Internet,
  6. At least one CGMglucose value < 70 mg/dL during the most recent 15 nights of CGM glucose data.
  7. Not pregnant or planning to become pregnant

Exclusion Criteria:

The exclusion criteria for this study is the following:

  1. The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
  2. The presence of any of the following diseases:

    • Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
    • Cystic fibrosis
    • Angina (recurrent heart pain)
    • Past heart attack or coronary artery (heart vessel) disease
    • Past stroke or impairment of blood flow to the brain
    • Other major illness that in the judgment of the investigator might interfere with the completion of the protocol Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
  3. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
  4. Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  5. Severe hypoglycemic event, as described as a seizure, loss of consciousness, severe neurological impairment, or neurological impairment suggestive of hypoglycemia and requiring an emergency department visit or hospitalization within 18 months of enrollment.

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): NCT00884611


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
Barbara Davis Center for Childhood Diabetes, University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Stanford University
University of Colorado, Denver
Investigators
Principal Investigator: Bruce A. Buckingham Stanford University

Publications of Results:
Responsible Party: Bruce A. Buckingham, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00884611     History of Changes
Other Study ID Numbers: SU-10162008-1321
Stanford eprotocol # 6789 ( Other Identifier: Stanford University )
First Posted: April 21, 2009    Key Record Dates
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018
Last Verified: January 2018

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