Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children (PSO4)

This study has been completed.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
In Home Closed Loop Study Group
ClinicalTrials.gov Identifier:
NCT01823341
First received: March 29, 2013
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Device: Pump suspension algorithm
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children

Resource links provided by NLM:


Further study details as provided by In Home Closed Loop Study Group:

Primary Outcome Measures:
  • 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. [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of sensor glucose values 71 to 180 mg/dL (3.9 to 10.0 mmol/L) [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
  • Proportion of nights with a sensor glucose value <=70 mg/dL (<=3.9 mmol/L) [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
  • Proportion of nights with sensor glucose value <=50 mg/dL (<=2.8 mmol/L) [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
  • For the nights when sensor glucose is <=60 mg/dL (<= 3.3 mmol/L), tabulation will be made as to whether blood glucose measured with study blood glucose meter [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
    For instances where blood glucose was measured using a study blood glucose meter, a comparison will be made between the sensor glucose values and meter blood glucose values.

  • Mean home glucose meter morning glucose [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
  • Morning glucose measured with home glucose meter >=250 mg/dL (>=13.9 mmol/L) [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
  • Morning blood ketones >1.0 mmol/L [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
  • Morning urine ketones >=small amount [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
  • Mean sensor glucose overnight [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
    Mean sensor glucose will be assessed over 24 hours and for 4 hours post system deactivation.

  • Percentage of sensor glucose values 71 to 180 mg/dL (3.9 to 10.0 mmol/L) overnight [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
    Percentage of sensor glucose values 71 to 180 mg/dL (3.9 to 10.0 mmol/L) overnight assessed over 24 hours and over the first 4 hours following system deactivation.

  • Area under the curve for sensor glucose <70 mg/dL (3.9 mmol/L), 60 mg/dL (3.3 mmol/L), and 50 mg/dL (2.8 mmol/L) [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
    Area under the curve will be assessed over 24 hours and over the first 4 hours following system deactivation.

  • Area under the curve sensor glucose >180 mg/dL (10.0 mmol/L) and 240 mg/dl (13.3 mmol/L) overnight [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
    Area under the curve will be assessed over 24 hours and over the first 4 hours following system deactivation.

  • Percent of nights with a CGM value > 250 mg/dL (13.9 mmol/L) [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
  • Morning glucose measured with home glucose meter >250 mg/dL (13.9 mmol/L) [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
  • Morning ketones >0.6 mmol/L [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
  • Episodes of Diabetic Ketoacidosis (DKA) [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
  • Episodes of severe hypoglycemia [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
  • Change in Hemoglobin A1c [ Time Frame: 42 nights ] [ Designated as safety issue: No ]
  • All reported adverse events [ Time Frame: 42 nights ] [ Designated as safety issue: Yes ]
  • The pump settings will be analyzed for any changes from the baseline visit [ Time Frame: 21 and 42 nights ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: May 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pump suspension algorithm
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
The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia.
No Intervention: Standard of Care
The control algorithm will run passively and not suspend the patient's pump.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 3 to <15 years
  • HbA1c <=8.5%
  • Availability of internet access for periodic upload of study data

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823341

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A4V2
Sponsors and Collaborators
In Home Closed Loop Study Group
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Roy W Beck, MD, PhD Jaeb Center for Health Research
Study Chair: Bruce A Buckingham, MD Stanford University
Study Director: John Lum, MS Jaeb Center for Health Research
  More Information

No publications provided

Responsible Party: In Home Closed Loop Study Group
ClinicalTrials.gov Identifier: NCT01823341     History of Changes
Other Study ID Numbers: PSO4, 5R01DK085591
Study First Received: March 29, 2013
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by In Home Closed Loop Study Group:
Type 1 Diabetes
Hypoglycemia
Continuous Glucose Monitoring
Pump Suspension

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014