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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 September 2016
• Main ID: NCT02438189
• Date of registration: 01/05/2015
• Prospective Registration: Yes
• Primary sponsor: Jaeb Center for Health Research
• Public title: Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms PHM2
• Scientific title: Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing
• Date of first enrolment: June 2015
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02438189
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Bruce Buckingham, MD
• Affiliation: Stanford University

• Name: John Lum, MS
• Affiliation: Jaeb Center for Health Research

• Name: Roy Beck, MD, PhD
• Affiliation: Jaeb Center for Health Research

Key inclusion & exclusion 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



Age minimum: 15 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes

Intervention(s)

Device: Hyperglycemia Minimization Algorithm

Primary Outcome(s)

Comparison of percent time in range overnight between the two treatment arms [Time Frame: Up to 42 nights]

Secondary Outcome(s)

Change in HbA1c from clinical baseline to study completion [Time Frame: Up to 42 nights]

Mean CGM glucose overnight [Time Frame: Up to 42 nights]

Mean home glucose meter morning glucose [Time Frame: Up to 42 nights]

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]

Percentage of time spent with CGM <50 mg/dL (2.8 mmol/L) [Time Frame: Up to 42 nights]

Percentage of time spent with CGM <70 mg/dL (3.9 mmol/L) [Time Frame: Up to 42 nights]

Amount of total insulin boluses [Time Frame: Up to 42 nights]

Percentage of time spent with CGM >250 mg/dL (13.9 mmol/L) [Time Frame: 42 nights]

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]

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]

Percentage of time spent with CGM <60 mg/dL (3.3 mmol/L) [Time Frame: Up to 42 nights]

Mean sensor glucose over 24 hours [Time Frame: Up to 42 nights]

Percentage of sensor glucose values 70 to 180 mg/dL (3.9 to 10.0 mmol/L) overnight [Time Frame: Up to 42 nights]

Percentage of time spent with CGM >300 mg/dL (16.7 mmol/L) [Time Frame: Up to 42 nights]

Percentage of time spent with CGM >180 mg/dL (10.0 mmol/L) [Time Frame: Up to 42 nights]

Glucose coefficient of variation (CV) [Time Frame: Up to 42 nights]

Mean sensor glucose 4 hours post system deactivation [Time Frame: Up to 42 nights]

Morning glucose measured with home glucose meter >250 mg/dL (13.9 mmol/L) [Time Frame: Up to 42 nights]

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]

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]

Secondary ID(s)

PHM2

5R01DK085591-05

RFA-DK-08-012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)