Outpatient Pump Shutoff Pilot Feasibility and Efficacy Study

NCT01591681 | Completed Phase 2 Results DMC

• 2 other identifiers: PSO31R01DK085591-01
• Study Type: interventional
• Target: 49
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. 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. This study has several phases and will take about 3 months for a patient to complete. Patients will use the Medtronic CGM with the Enlite sensor at home for 10-15 days to be sure that they are able and willing to use this system and to determine if they meet the investigators study criteria to proceed with the next phase of the study. Patients will be provided teaching on how to use CGM data in real time. If a patient is not using a Medtronic CGM already, the patient will first use one at home for 10-15 days to be sure that he/she is able and willing to use it. If a patient is already using a Medtronic CGM, then his/her most recent 10-15 days of data will be used to find out if he/she is eligible. Those who need to complete the CGM run-in phase will have an extra office visit for training. If eligible to continue in the study, patients will need to use the study system for 5 nights at home so that the investigators can make sure they are able to use it correctly. After that, patients will be asked to use the study system each night for an additional 6 to 8 weeks. If the system is active and predicts that a patient's blood sugar will become low, the insulin pump will shut off for up to 2 hours. The study will include about 45 individuals at 3 clinical centers in the United States and Canada.

Conditions

Type 1 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hypoglycemia Outcome: Percentage of Nights With Sensor Glucose Value </=60 mg/dl

  Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤60 mg/dL. The percentage of hypoglycemic nights will be tabulated separately with versus without the closed-loop control system in use. A repeated measures logistic regression model will be used to compare intervention versus control nights accounting for correlated data from the same subject and adjusting for the baseline (bedtime) sensor glucose.

  Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use

Secondary Outcomes (10)

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

  Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use

• Percentage of Nights With a Sensor Glucose Value </= 70 mg/dL

  Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use

• Proportion of Nights With a Sensor Glucose Value </= 50 mg/dL

  Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use

• Median Morning Blood Glucose

  42 mornings following night of system use

• Percent of Mornings With Glucose >250 mg/dL

  42 mornings following night of system use

Study Arms (2)

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 control the patient's pump.

Interventions

Pump suspension DEVICE

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

Pump suspension algorithm

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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 \>/= 15.0 - 45 years
• HbA1c \</= 8.0%
• Availability of internet access for periodic upload of study data

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)
• History of any heart disease including coronary artery disease, heart failure, or arrhythmiasCoronary 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), or liver disease (Creatinine \> 1.5 mg/dL (0.08 mmol/L))
• 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
• Abuse of alcohol
• Pregnancy
• Liver disease as defined by an ALT greater than 3 times the upper limit of normal

Sponsors & Collaborators

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

Study Sites (3)

Stanford University

Stanford, California, 94305, United States

Location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

St. Joseph's Health Care

London, Ontario, N6A4V2, Canada

Location

Related Publications (2)

• Maahs DM, Calhoun P, Buckingham BA, Chase HP, Hramiak I, Lum J, Cameron F, Bequette BW, Aye T, Paul T, Slover R, Wadwa RP, Wilson DM, Kollman C, Beck RW; In Home Closed Loop Study Group. A randomized trial of a home system to reduce nocturnal hypoglycemia in type 1 diabetes. Diabetes Care. 2014 Jul;37(7):1885-91. doi: 10.2337/dc13-2159. Epub 2014 May 7.

  PMID: 24804697 RESULT

• Wilson DM, Calhoun PM, Maahs DM, Chase HP, Messer L, Buckingham BA, Aye T, Clinton PK, Hramiak I, Kollman C, Beck RW; In Home Closed Loop Study Group. Factors associated with nocturnal hypoglycemia in at-risk adolescents and young adults with type 1 diabetes. Diabetes Technol Ther. 2015 Jun;17(6):385-91. doi: 10.1089/dia.2014.0342. Epub 2015 Mar 11.

  PMID: 25761202 DERIVED

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, M.D., Ph.D.
• Organization: Jaeb Center for Health Research

jdrfapp2@jaeb.org

813-975-8690

Study Officials

• Roy Beck, MD, Ph.D.

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

• Bruce Buckingham, MD

  Stanford University

  STUDY CHAIR

• 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: April 30, 2012
• First Posted: May 4, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 30, 2016
• Results First Posted: June 5, 2014

Record last verified: 2016-08

Locations

CA (1); US (2)