Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform

NCT02750267 | Completed Results DMC

• 1 other identifier: 18888
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes Mellitus (T1DM); Artificial Pancreas Project (APP); Diabetes Assistant (DiAs); Closed-Loop Control (CLC); Continuous Glucose Monitor; Pediatric; Insulin Pump

Outcome Measures

Primary Outcomes (1)

• Percent of Sensor Glucose Readings Between 70-180 mg/dL

  All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.

  68 hours

Secondary Outcomes (16)

• Percent of Time Sensor Glucose Readings Are <70 mg/dL

  68 hours

• Percent of Time Sensor Glucose Readings Are >150 mg/dL

  72 hours

• Percent of Time Sensor Glucose Readings Are >180 mg/dL

  68 hours

• Percent of Time Sensor Glucose Readings Are >250 mg/dL

  68 hours

• Percent of Time Sensor Glucose Readings Are >400 mg/dL

  72 hours

Study Arms (2)

Group A

EXPERIMENTAL

In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.

Device: Diabetes Assistant (DiAs) with Closed-Loop

Group B

EXPERIMENTAL

Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.

Device: Diabetes Assistant (DiAs) with Closed-Loop

Interventions

Diabetes Assistant (DiAs) with Closed-Loop DEVICE

All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.

Group A; Group B

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of type 1 diabetes,
• The diagnosis of type 1 diabetes is based on the investigator's judgment
• C peptide levels and antibody determinations are not required
• Daily insulin therapy for ≥ 12 months
• Insulin pump therapy for ≥ 3 months
• Age ≥5 - ≤8 years old
• Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
• Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study

You may not qualify if:

• Diabetic ketoacidosis in the past month
• Hypoglycemic seizure or loss of consciousness in the past 3 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 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).
• Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
• Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
• Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if these criteria are not met. The study subject will not participate in the trial if these conditions are met.
• 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 insufficiency

Sponsors & Collaborators

• University of Virginia: lead
• DexCom, Inc.: collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• DeBoer MD, Breton MD, Wakeman C, Schertz EM, Emory EG, Robic JL, Kollar LL, Kovatchev BP, Chernavvsky DR. Performance of an Artificial Pancreas System for Young Children with Type 1 Diabetes. Diabetes Technol Ther. 2017 May;19(5):293-298. doi: 10.1089/dia.2016.0424. Epub 2017 Apr 20.

  PMID: 28426239 BACKGROUND

Related Links

• Use of an AP in young children was safe and resulted in improved mean BG without increased hypoglycemia. This suggests that AP use in young children is safe and improves overall diabetes control.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Daniel R. Chernavvsky
• Organization: Center for Diabetes Technology

drc2v@virginia.edu

4342431395

Study Officials

• Mark D. DeBoer, MD

  University of Virginia, Pediatrics, Endocrinology/Diabetes

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 25, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 24, 2017
• Results First Posted: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)