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Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms (PHM2)

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ClinicalTrials.gov Identifier: NCT02438189
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : August 29, 2016
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 with in-home use of a modified 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.

Major Eligibility Criteria: clinical diagnosis of type 1 diabetes, daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months; 15.0 to <46.0 years of age; HbA1c < 10.0%; no DKA in last 6 months; no hypoglycemic seizure or loss of consciousness in last 6 months; Living with a significant other or family member ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night.

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 Device: Hyperglycemia Minimization Algorithm Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing
Study Start Date : June 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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 hyperglycemia minimization active algorithm nights will be compared with the corresponding percentage obtained by pooling all of the data from control nights for the same subject. All CGM readings will be weighted equally in the pooled percentage regardless of how they distribute across nights.


Secondary Outcome Measures :
  1. Mean CGM glucose overnight [ Time Frame: Up to 42 nights ]
  2. Percentage of time spent with CGM <50 mg/dL (2.8 mmol/L) [ Time Frame: Up to 42 nights ]
  3. Percentage of time spent with CGM <60 mg/dL (3.3 mmol/L) [ Time Frame: Up to 42 nights ]
  4. Percentage of time spent with CGM <70 mg/dL (3.9 mmol/L) [ Time Frame: Up to 42 nights ]
  5. Percentage of time spent with CGM >180 mg/dL (10.0 mmol/L) [ Time Frame: Up to 42 nights ]
  6. Percentage of time spent with CGM >250 mg/dL (13.9 mmol/L) [ Time Frame: 42 nights ]
  7. Percentage of time spent with CGM >300 mg/dL (16.7 mmol/L) [ Time Frame: Up to 42 nights ]
  8. Percentage of nights with >30 min and >60 min consecutive CGM values <50 mg/dL (2.8 mmol/L) [ Time Frame: Up to 42 nights ]
  9. Percentage of nights with >30 min and >60 min consecutive CGM values <60 mg/dL (3.3 mmol/L) [ Time Frame: Up to 42 nights ]
  10. Percentage of nights with >30 min and >60 min consecutive CGM values <70 mg/dL (3.9 mmol/L) [ Time Frame: Up to 42 nights ]
  11. Glucose coefficient of variation (CV) [ Time Frame: Up to 42 nights ]
  12. Amount of total insulin boluses [ Time Frame: Up to 42 nights ]
  13. Mean home glucose meter morning glucose [ Time Frame: Up to 42 nights ]
  14. Morning glucose measured with home glucose meter >250 mg/dL (13.9 mmol/L) [ Time Frame: Up to 42 nights ]
  15. Mean sensor glucose over 24 hours [ Time Frame: Up to 42 nights ]
  16. Mean sensor glucose 4 hours post system deactivation [ Time Frame: Up to 42 nights ]
  17. Percentage of sensor glucose values 70 to 180 mg/dL (3.9 to 10.0 mmol/L) overnight [ Time Frame: Up to 42 nights ]
  18. Percentage of sensor glucose values 70 to 180 mg/dL (3.9 to 10.0 mmol/L) 4 hours after system deactivation [ Time Frame: Up to 42 nights ]
  19. Percentage of sensor glucose values 70 to 180 mg/dL (3.9 to 10.0 mmol/L) over 24 hours [ Time Frame: Up to 42 nights ]
  20. Change in HbA1c from clinical baseline to study completion [ Time Frame: Up to 42 nights ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
  • Age 15.0 to <46.0 years
  • 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.
  • Uninterrupted internet access while study system is being used overnight and for upload of study data in the morning
  • Living with a significant other or family member ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night
  • An understanding of and willingness to follow the protocol and sign the informed consent

Exclusion Criteria:

  • 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 arrhythmias
  • 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 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.
  • 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 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.
  • 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): NCT02438189


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
Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A4V2
Sponsors and Collaborators
Jaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Roy Beck, MD, PhD Jaeb Center for Health Research
Study Chair: Bruce Buckingham, MD Stanford University
Study Director: John Lum, MS Jaeb Center for Health Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02438189     History of Changes
Other Study ID Numbers: PHM2
RFA-DK-08-012 ( Other Grant/Funding Number: NIDDK )
5R01DK085591-05 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016

Keywords provided by Jaeb Center for Health Research:
Type 1 Diabetes
Hypoglycemia
Hyperglycemia
Artificial Pancreas

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Hypoglycemia
Hyperglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs