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

• 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: Stanford University
• Collaborator: University of Colorado, Denver
• Information provided by (Responsible Party): Bruce A. Buckingham, Stanford University

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

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

More Information

Publications of Results:

Buckingham BA, Cameron F, Calhoun P, Maahs DM, Wilson DM, Chase HP, Bequette BW, Lum J, Sibayan J, Beck RW, Kollman C. Outpatient safety assessment of an in-home predictive low-glucose suspend system with type 1 diabetes subjects at elevated risk of nocturnal hypoglycemia. Diabetes Technol Ther. 2013 Aug;15(8):622-7. doi: 10.1089/dia.2013.0040. Epub 2013 Jul 24.

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

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases