Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children

NCT01823341 | Completed Phase 2 Results DMC

• 2 other identifiers: PSO45R01DK085591
• Study Type: interventional
• Target: 97
• 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 continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular laptop computer. A The system works by (1) measuring the glucose levels under the skin with the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is likely to occur, and (3) turning off the insulin pump when the computer program predicts that a low blood sugar will occur. We have tested the system in the home environment in individuals with type 1 diabetes age 15 years and older. We have found an indication that the system can decrease the frequency of hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We are now ready to further test the system in the home environment in a younger age group to learn more about its ability to reduce overnight low blood sugar risk. This study has several phases and will take about 3 months for a patient to complete.

• First, the patient will use the CGM and pump at home for up to 15 days with the help of a parent/guardian. This is done to determine if the patient meets our study criteria to proceed with the next phase of the study.
• If the patient is eligible to continue in the study, the patient will need to use the full study system for at least 5 nights at home with the help of a parent/guardian. This is done to make sure the patient and parent/guardian are able to use the system correctly. The patient may participate in starting and stopping the system at home, but the parent/guardian is responsible for making sure it is used as instructed.
• After that, the patient will be asked to use the study system each night for an additional 6 to 8 weeks. The parent/guardian will remain responsible for making sure the system is used as instructed. The study will include about 90 individuals with type 1 diabetes at 3 clinical centers in the United States and Canada. First a study of children 8 to less than 15 years old will be done. Then, a study of children 3 to less than 8 years old will be conducted.

Conditions

Type 1 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Comparison of the Time Spent in Hypoglycemia (<70 mg/dl, 3.9 mmol/L) Overnight on Intervention Nights Versus Control Nights, Normalized to an 8-hour Period.

  Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤70 mg/dL (3.9 mmol/L). The time period for outcome assessment each night will be from the time the system is activated in the evening until the time it is deactivated in the morning. The percentage of hypoglycemic nights (CGM glucose value ≤70 mg/dL (3.9 mmol/L)) will be tabulated separately with versus without the closed-loop control system in use. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.

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

Secondary Outcomes (9)

• Percentage of Nights With 1 or More Sensor Glucose Values <70 mg/dL (<3.9 mmol/L)

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

• Percentage of Nights With 1 or More Sensor Glucose Values <50 mg/dL (<2.8 mmol/L)

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

• Mean Sensor Glucose Overnight

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

• Percentage of Time Overnight Sensor Glucose Values 71 to 180 mg/dL (3.9 to 10.0 mmol/L), Normalized to an 8-hour Period.

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

• Percentage of Overnight Time Spent With CGM Value >250 mg/dL (13.9 mmol/L), Normalized to an 8-hour Period.

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

Study Arms (2)

Pump suspension algorithm

ACTIVE COMPARATOR

The pump suspension algorithm will be running actively on the study laptop during the night and suspend the pump if the algorithm predicts hypoglycemia.

Device: Pump suspension algorithm

Standard of Care

NO INTERVENTION

The control algorithm will run passively and not suspend the patient's pump.

Interventions

Pump suspension algorithm DEVICE

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

Pump suspension algorithm

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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 3 to \<15 years
• HbA1c \<=8.5%
• 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 past 6 months
• History of seizure disorder (except for hypoglycemic seizures)
• 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 is \> 1.5 mg/dL (132 µmol/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 Alanine Aminotransferase Test (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
• Juvenile Diabetes Research Foundation: 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 (1)

• Buckingham BA, Raghinaru D, Cameron F, Bequette BW, Chase HP, Maahs DM, Slover R, Wadwa RP, Wilson DM, Ly T, Aye T, Hramiak I, Clarson C, Stein R, Gallego PH, Lum J, Sibayan J, Kollman C, Beck RW; In Home Closed Loop Study Group. Predictive Low-Glucose Insulin Suspension Reduces Duration of Nocturnal Hypoglycemia in Children Without Increasing Ketosis. Diabetes Care. 2015 Jul;38(7):1197-204. doi: 10.2337/dc14-3053. Epub 2015 Jun 6.

  PMID: 26049549 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

Limitations and Caveats

Only selected participants prone to nocturnal hypoglycemia and only tested one continuous glucose sensor. Participants didn't know if system was active before activation so could not observe what would happen if the participants knew it was.

Results Point of Contact

• Title: Judy Sibayan, MPH, CCRP
• Organization: Jaeb Center for Health Research

jsibayan@jaeb.org

813-975-8690

Study Officials

• Roy W Beck, MD, PhD

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

• Bruce A 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: March 29, 2013
• First Posted: April 4, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 30, 2016
• Results First Posted: August 24, 2015

Record last verified: 2016-08

Locations

US (2); CA (1)