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

NCT02714972 | Completed Phase 2 DMC

• 1 other identifier: PHM3
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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

Conditions

Type 1 Diabetes; Hypoglycemia; Hyperglycemia; Artificial Pancreas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Mean overnight sensor glucose

  Up to 42 nights

• Glucose standard deviation and coefficient of variation

  Up to 42 nights

• Percent of sensor measurements below 50 mg/dl (2.8 mmol/L)

  Up to 42 nights

• Percent of sensor measurements below 60 mg/dl (3.3 mmol/L)

  Up to 42 nights

• Percent of sensor measurements below 70 mg/dl (3.9 mmol/L)

  Up to 42 nights

Study Arms (2)

Hyperglycemia Minimization Algorithm

ACTIVE COMPARATOR

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

Predictive Low Glucose Suspend

NO INTERVENTION

The control algorithm will run passively and not dose additional insulin. If hypoglycemia is predicted, the system will suspend the pump.

Interventions

Hyperglycemia Minimization Algorithm DEVICE

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.

Hyperglycemia Minimization Algorithm

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 6.0 to \<15.0 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 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
• An understanding of and willingness to follow the protocol and sign the informed consent

You may not qualify if:

• Diabetic ketoacidosis in the past 6 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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bruce A Buckingham, MD

  Stanford University

  STUDY CHAIR

• John W Lum, MS

  Jaeb Center for Health Research

  STUDY DIRECTOR

• Roy Beck, MD, PhD

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Subjects are randomized on a per-night level for when the PHHM will be active or not.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 22, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

US (2)