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

NCT ID: NCT00884611

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-08-31

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.

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Predictive Low Glucose Suspend Algorithm ON

Intervention Type: 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.

Predictive Low Glucose Suspend Algorithm OFF

Intervention Type: DEVICE

Interventions

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.

Intervention Type: DEVICE

Predictive Low Glucose Suspend Algorithm OFF

Intervention Type: DEVICE

Other Intervention Names

Intervention Night; Control Night

Eligibility 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

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Bruce A. Buckingham

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce A. Buckingham

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Barbara Davis Center for Childhood Diabetes, University of Colorado

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23883408 (View on PubMed)

Other Identifiers

Stanford eprotocol # 6789

Identifier Type: OTHER

Identifier Source: secondary_id

SU-10162008-1321

Identifier Type: -

Identifier Source: org_study_id