An Outpatient Pump Shutoff Pilot Feasibility and Safety Study

NCT ID: NCT01736930

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-06-30

Brief Summary

The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur. We have tested this system overnight in the hospital and are ready to test the system in the home environment to learn more about how well it will work and to make sure that the blood sugar does not go too high when the pump shuts off.

This study has several phases and will take about a month or a little more for a patient to complete. Patients will use the study system for about 5 days at home to show that the patient is able to use it correctly. After that, the patient will be asked to use the study system each night for an additional 3-4 weeks. During this time, the system will be active for two-thirds of the nights and not active for one-third of the nights. When the system is active and predicts that your blood sugar will become low, the insulin pump will shut off for up to 2 hours.

The study will include 2 clinical centers in the United States.

Detailed Description

Patients who meet all eligibility criteria will use the study system overnight at home for about 5 nights to demonstrate their ability to use the system and submit study data to the Coordinating Center.

Patients who successfully demonstrate their ability to use the system as described above will be eligible for the randomized trial phase. This phase consists of use of the full system as an outpatient for approximately 21 nights:

• Each night the blood glucose level will be checked with the study blood glucose (BG) meter and used to perform a calibration of the CGM. The calibration must occur no more than 90 minutes prior to activation of the system. NOTE: Patients will be instructed to calibrate the CGM per manufacturer guidelines.
• Then the system will be activated, linking the CGM and insulin pump to the computer at the bedside.
• A randomization schedule on the laptop will be used to determine whether the 'pump shut off' application will be active that night or not.
• Patients will be blinded as to whether the pump shut off is active when a session is initiated each night.
• There will not be an alarm if the pump shuts off. The CGM alarm will be set to 60 mg/dL. When a CGM alarm occurs, the patient will be asked to measure the blood glucose with a BG meter, if he/she is aware of the alarm.
• The time period for outcome assessment each night will be from the time the system is activated until it is turned off in the morning.
• Pump shut off, when it occurs, will be for up to 2 hours. Multiple instances of pump suspension can occur if there are recurrent predictions of hypoglycemia during the night.
• Patients will be asked to check blood glucose with the study BG meter, blood ketones with the study ketone meter, and urine ketones with a ketone strip each morning prior to breakfast and enter the results on the study laptop. The patient will be instructed to contact the study physician if the blood glucose or ketone readings are out of an expected range. Patients will be contacted if these morning safety values are not reported as required or are out of range.
• Patients will be asked to record all overnight carbohydrate intake on the study laptop.
• Patients will be asked to perform periodic data uploads using the study laptop. Monitoring processes will ensure that the patient is contacted if these uploads do not occur as required, or if review of an upload reveals any extreme, prolonged episodes of low or high blood glucose readings, or elevated morning blood glucose, blood ketone, or urine ketone values.

Upon completion of the study, patients as well as study clinicians will be asked to complete a questionnaire regarding use of the study system.

There will a follow-up visit after completion of 21 successful nights of study system use. A successful night of study system use is defined as use of the system for at least four hours. Phone contacts with the patients will be made once a week.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Predictive pump suspension algorithm

The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.

Group Type: ACTIVE_COMPARATOR

Pump suspension

Intervention Type: DEVICE

The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

Standard of Care

The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pump suspension

The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months
• Age >=18.0 years
• HbA1c <=8.0%
• Availability of internet access for periodic upload of study data
• Experience using the Medtronic pump and CGM and investigator is confident that subject will use CGM on a near-daily basis during the study
• Nocturnal hypoglycemia meeting the following criterion based on CGM download: during the most recent 15 nights with CGM glucose data (must be within the past 42 days), one or more nights with a sensor glucose value <=70 mg/dL.

Exclusion Criteria

• Diabetic ketoacidosis in the past 3 months
• Hypoglycemic seizure or loss of consciousness in the past 6 months
• History of seizure disorder (except for hypoglycemic seizure)
• Coronary artery disease or heart failure
• 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). Creatinine level to have been obtained within the last year if subject has diabetes of >10 years duration or is over 50 years of age. If creatinine is > 1.5 mg/dL, the subject is excluded.
• History of liver disease
• 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, and/or abuse of alcohol
• Pregnancy: A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce A Buckingham, MD

Role: STUDY_CHAIR

Stanford University

Roy W Beck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jaeb Center for Health Research

John Lum, MS

Role: STUDY_DIRECTOR

Jaeb Center for Health Research

Locations

Stanford University

Stanford, California, United States

Barbara Davis Center for Childhood Diabetes

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

R01DK085591

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PSO1

Identifier Type: -

Identifier Source: org_study_id