An Outpatient Pump Shutoff Pilot Feasibility and Safety Study

NCT01736930 | Completed Phase 2 Results DMC

• 2 other identifiers: PSO1R01DK085591
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Hypoglycemia; Continuous Glucose Monitoring; Pump Suspension

Outcome Measures

Primary Outcomes (12)

• Mean Morning Blood Glucose (mg/dL)- Algorithm 1

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). An objective was to evaluate and refine the control algorithm. The data were reviewed periodically during the study with the pre-stated goal of determining whether any changes should be made in the control algorithm. Algorithm 1 was used for the first 105 nights of the study (38 Control nights and 67 Intervention nights). The horizon prediction time of algorithm 1 was set at 70 minutes.

  21 study nights

• Mean Morning Blood Glucose (mg/dL)- Algorithm 2

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). Algorithm 1 was modified to reduce the hypoglycemia prediction horizon from 70 minutes to 50 minutes, to suspend the pump only when the continuous glucose monitor sensor glucose value was ≤ 230 mg/dl, not suspend if there was a drop of \>40 mg/dl in consecutive sensor glucose readings, and to resume insulin delivery at the first rise in sensor glucose following a suspension. There was 156 nights of study data collected (48 Control nights and 108 Intervention nights) using algorithm 2.

  21 study nights

• Mean Morning Blood Glucose (mg/dL)- Algorithm 3

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). The hypoglycemia prediction horizon was reduced further in algorithm 3 to 30 minutes. A total of 114 study nights (37 Control nights and 77 Intervention nights) using algorithm 3.

  21 study nights

• Percent Morning Blood Glucose >250 mg/dL - Algorithm 1

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as the overall percentage of mornings glucose measured with home glucose meter \>250 mg/dL.

  21 days

• Percent Morning Blood Glucose >250 mg/dL - Algorithm 2

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter \>250 mg/dL.

  21 days

• Percent Morning Blood Glucose >250 mg/dL - Algorithm 3

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter \>250 mg/dL.

  21 days

• Mornings With Blood Ketones >0.6 mmol/L - Algorithm 1

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones \>0.6 mmol/L.

  21 days

• Mornings With Blood Ketones >0.6 mmol/L - Algorithm 2

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones \>0.6 mmol/L.

  21 days

• Mornings With Blood Ketones >0.6 mmol/L - Algorithm 3

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones \>0.6 mmol/L.

  21 days

• Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 1

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large \>80 mg/dL.

  21 days

• Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 2

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large \>80 mg/dL.

  21 days

• Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 3

  The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large \>80 mg/dL.

  21 days

Secondary Outcomes (6)

• Mean Sensor Glucose Overnight - Algorithm 1

  Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use

• Mean Sensor Glucose Overnight - Algorithm 2

  Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use

• Mean Sensor Glucose Overnight - Algorithm 3

  Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use

• Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 1

  Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use

• Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 2

  Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use

Study Arms (2)

Predictive pump suspension algorithm

ACTIVE COMPARATOR

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.

Device: Pump suspension

Standard of Care

NO INTERVENTION

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

Interventions

Pump suspension 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.

Predictive pump suspension algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

Barbara Davis Center for Childhood Diabetes

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; Hypoglycemia

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: Roy W. Beck, MD, PhD
• Organization: Jaeb Center for Health Resesarch

jdrfapp2@jaeb.org

813-975-8690

Study Officials

• Bruce A Buckingham, MD

  Stanford University

  STUDY CHAIR

• Roy W Beck, MD, PhD

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

• John Lum, MS

  Jaeb Center for Health Research

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 29, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 30, 2016
• Results First Posted: April 14, 2014

Record last verified: 2016-08

Locations

US (2)