Type 1 Diabetes Clinical Trial
— PHM3Official title:
Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents (PHM3)
Verified date | May 2017 |
Source | Jaeb Center for Health Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 35 |
Est. completion date | May 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 14 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Barbara Davis Center for Childhood Diabetes | Aurora | Colorado |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Jaeb Center for Health Research | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of percent time in range overnight between the two treatment arms | 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. | Up to 42 nights | |
Secondary | Mean overnight sensor glucose | Up to 42 nights | ||
Secondary | Glucose standard deviation and coefficient of variation | Up to 42 nights | ||
Secondary | Percent of sensor measurements below 50 mg/dl (2.8 mmol/L) | Up to 42 nights | ||
Secondary | Percent of sensor measurements below 60 mg/dl (3.3 mmol/L) | Up to 42 nights | ||
Secondary | Percent of sensor measurements below 70 mg/dl (3.9 mmol/L) | Up to 42 nights | ||
Secondary | Area under the curve 70 mg/dl (3.9 mmol/L) | Up to 42 nights | ||
Secondary | Low blood glucose index | Up to 42 nights | ||
Secondary | Percent of sensor measurements above 180 mg/dl (10.0 mmol/L) | Up to 42 nights | ||
Secondary | Percent of sensor measurements above 250 mg/dl (13.9 mmol/L) | Up to 42 nights | ||
Secondary | Percent of sensor measurements above 300 mg/dl (16.7 mmol/L) | Up to 42 nights | ||
Secondary | Area under the curve 180 mg/dl (10.0 mmol/L) | Up to 42 nights | ||
Secondary | High blood glucose index | Up to 42 nights | ||
Secondary | Percent of sensor measurements between 70 mg/dl (3.9 mmol/L) | Up to 42 nights | ||
Secondary | Percent of sensor measurements between 140 mg/dl (7.8 mmol/L) | Up to 42 nights | ||
Secondary | 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 | Up to 42 nights | ||
Secondary | 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 | Up to 42 nights | ||
Secondary | 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 | Up to 42 nights | ||
Secondary | 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 | Up to 42 nights | ||
Secondary | 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) | Up to 42 nights | ||
Secondary | 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) | Up to 42 nights | ||
Secondary | 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) | Up to 42 nights | ||
Secondary | Amount of total (manual, automatic, combined) and insulin boluses | Up to 42 nights |
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