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Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents (PHM3)

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ClinicalTrials.gov Identifier: NCT02714972
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:

Objective: to gain experience in children and younger adolescents with in-home use of an algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data

Study Design: randomized controlled trial, with randomization on a night level within subject Patient Population: Youth 6.0 - <15 years old with type 1 diabetes treated with daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months who have HbA1c < 10.0%.

Sample Size: 30 subjects

Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use

Major Efficacy Outcomes:

  • Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.
  • Secondary: time spent in hypoglycemia (<70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight.

Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Hypoglycemia Hyperglycemia Artificial Pancreas Device: Hyperglycemia Minimization Algorithm Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Subjects are randomized on a per-night level for when the PHHM will be active or not.
Primary Purpose: Prevention
Official Title: Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents (PHM3)
Actual Study Start Date : May 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Active Comparator: Hyperglycemia Minimization Algorithm
The hyperglycemia minimization algorithm will be running actively on the study laptop during the night and dose insulin if the algorithm predicts hyperglycemia. If hypoglycemia is predicted, the system will suspend the pump.
Device: Hyperglycemia Minimization Algorithm
The hyperglycemia minimization algorithm will be running actively on the study laptop during the night and dose insulin if the algorithm predicts hyperglycemia. If hypoglycemia is predicted, the system will suspend the pump.

No Intervention: Predictive Low Glucose Suspend
The control algorithm will run passively and not dose additional insulin. If hypoglycemia is predicted, the system will suspend the pump.



Primary Outcome Measures :
  1. Comparison of percent time in range overnight between the two treatment arms [ Time Frame: Up to 42 nights ]
    A single percentage calculated for each subject by pooling all CGM readings from the PLSG+HM nights will be compared with the corresponding percentage obtained by pooling all of the data from PLGS-only nights for the same subject. All CGM readings regardless of the amount of data will be weighted equally in the pooled percentage regardless of how they distribute across nights.


Secondary Outcome Measures :
  1. Mean overnight sensor glucose [ Time Frame: Up to 42 nights ]
  2. Glucose standard deviation and coefficient of variation [ Time Frame: Up to 42 nights ]
  3. Percent of sensor measurements below 50 mg/dl (2.8 mmol/L) [ Time Frame: Up to 42 nights ]
  4. Percent of sensor measurements below 60 mg/dl (3.3 mmol/L) [ Time Frame: Up to 42 nights ]
  5. Percent of sensor measurements below 70 mg/dl (3.9 mmol/L) [ Time Frame: Up to 42 nights ]
  6. Area under the curve 70 mg/dl (3.9 mmol/L) [ Time Frame: Up to 42 nights ]
  7. Low blood glucose index [ Time Frame: Up to 42 nights ]
  8. Percent of sensor measurements above 180 mg/dl (10.0 mmol/L) [ Time Frame: Up to 42 nights ]
  9. Percent of sensor measurements above 250 mg/dl (13.9 mmol/L) [ Time Frame: Up to 42 nights ]
  10. Percent of sensor measurements above 300 mg/dl (16.7 mmol/L) [ Time Frame: Up to 42 nights ]
  11. Area under the curve 180 mg/dl (10.0 mmol/L) [ Time Frame: Up to 42 nights ]
  12. High blood glucose index [ Time Frame: Up to 42 nights ]
  13. Percent of sensor measurements between 70 mg/dl (3.9 mmol/L) [ Time Frame: Up to 42 nights ]
  14. Percent of sensor measurements between 140 mg/dl (7.8 mmol/L) [ Time Frame: Up to 42 nights ]
  15. Percentage of nights with events of sensor glucose below 50 mg/dl (2.8 mmol/L), 60 mg/dl (3.3 mmol/L), and 70 mg/dl (3.9 mmol/L) continuously for more than 0, 10, 25, 30, 60, and 120 minutes [ Time Frame: Up to 42 nights ]
  16. Percentage of nights with events of sensor glucose below 50 mg/dl (2.8 mmol/L), 60 mg/dl (3.3 mmol/L), and 70 mg/dl (3.9 mmol/L) cumulatively for more than 30, 60, 120, and 180 minutes [ Time Frame: Up to 42 nights ]
  17. Percentage of nights with events of sensor glucose above 180 mg/dl (10.0 mmol/L), 250 mg/dl (13.9 mmol/L), and 300 mg/dl (16.7 mmol/L) continuously for more than 0, 30, 60, and 120 minutes [ Time Frame: Up to 42 nights ]
  18. Percentage of nights with events of sensor glucose above 180 mg/dl (10.0 mmol/L), 250 mg/dl (13.9 mmol/L), and 300 mg/dl (16.7 mmol/L) cumulatively for more than 60, 120, and 180 minutes [ Time Frame: Up to 42 nights ]
  19. Mean morning blood glucose (subject-level data) and percent of morning with blood glucose below 50 mg/dl (2.8 mmol/L), 60 mg/dl (3.3 mmol/L), 70 mg/dl (3.9 mmol/L) (night-level data) [ Time Frame: Up to 42 nights ]
  20. Mean morning blood glucose (subject-level data) and percent of morning with blood glucose between 70 mg/dl (3.9 mmol/L) and 180 mg/dl (10.0 mmol/L) (night-level data) [ Time Frame: Up to 42 nights ]
  21. Mean morning blood glucose (subject-level data) and percent of morning with blood glucose above 180 mg/dl (10.0 mmol/L), 250 mg/dl (13.9 mmol/L), and 300 mg/dl (16.7 mmol/L) (night-level data) [ Time Frame: Up to 42 nights ]
  22. Amount of total (manual, automatic, combined) and insulin boluses [ Time Frame: Up to 42 nights ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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 The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
  2. Age 6.0 to <15.0 years
  3. HbA1c < 10.0%

    • Measured with DCA2000 or equivalent device for assessing eligibility
    • HbA1c measurements performed as part of usual clinical care within 2 weeks prior to obtaining informed consent for participation in the trial may be used.
  4. Uninterrupted internet access while study system is being used overnight and for upload of study data in the morning
  5. Living with a family member/guardian ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night
  6. An understanding of and willingness to follow the protocol and sign the informed consent

Exclusion Criteria:

  1. Diabetic ketoacidosis in the past 6 months
  2. Hypoglycemic seizure or loss of consciousness in the past 6 months
  3. History of seizure disorder (except for hypoglycemic seizure)
  4. History of any heart disease including coronary artery disease, heart failure, or arrhythmias
  5. Cystic fibrosis
  6. 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.
  7. History of ongoing renal disease (other than microalbuminuria). Creatinine level must have been obtained within the last year if subject has diabetes of >10 years duration. If creatinine is > 1.5 mg/dL (132 µmol/L), the subject is excluded.
  8. 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
  9. Pregnancy (Negative urine pregnancy test required for females who have experienced menarche as well as agreement from subject and parent/guardian to use a form of contraception to prevent pregnancy while participant is in the study. Subjects who become pregnant will be discontinued from the study)
  10. Liver disease as defined by an ALT greater than 3 times the upper limit of normal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714972


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Jaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Study Chair: Bruce A Buckingham, MD Stanford University
Study Director: John W Lum, MS Jaeb Center for Health Research
Principal Investigator: Roy Beck, MD, PhD Jaeb Center for Health Research
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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02714972    
Other Study ID Numbers: PHM3
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Hypoglycemia
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases