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

NCT00884611 | Completed Results

• 2 other identifiers: SU-10162008-1321Stanford eprotocol # 6789
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Percentage of Nights With CGM (Continuous Glucose Monitor) Sensor Values < 60 mg/dL

  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.

  21 days

Secondary Outcomes (2)

• Percentage of Nights With CGM Values >180 mg/dL

  21 days

• Mean Morning Blood Glucose (BG)

  21 days

Study Arms (1)

Predictive Low Glucose Suspend

EXPERIMENTAL

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; Device: Predictive Low Glucose Suspend Algorithm OFF

Interventions

Predictive Low Glucose Suspend Algorithm ON DEVICE

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.

Also known as: Intervention Night

Predictive Low Glucose Suspend

Predictive Low Glucose Suspend Algorithm OFF DEVICE

Also known as: Control Night

Predictive Low Glucose Suspend

Eligibility Criteria

• Age: 12 Years - 46 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
• 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
• 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.

Sponsors & Collaborators

• Stanford University: lead
• University of Colorado, Denver: collaborator

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Barbara Davis Center for Childhood Diabetes, University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 23883408 RESULT

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: Dr. Bruce Buckingham, MD
• Organization: Stanford University

buckingham@stanford.edu

Study Officials

• Bruce A. Buckingham

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 21, 2009
• Study Start: May 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 28, 2018
• Results First Posted: February 28, 2018

Record last verified: 2018-01

Locations

US (2)