Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp

NCT03369067 | Completed Results FDA Device

• 1 other identifier: 20335
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

An early feasibility study that will test the efficacy of the Tandem t:slim X2 with Control-IQ and Dexcom Continuous Glucose System G6 in a winter/ski camp environment.

Conditions

Type 1 Diabetes Mellitus

Keywords

Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Closed Loop Control (CLC); Insulin Pump

Outcome Measures

Primary Outcomes (4)

• Percent Time Spent Between 70 and 180 mg/dL

  The primary outcome was the percent time spent between 70 and 180 mg/dL during the 48hr study admission.

  Overall [48hr study admission]

• Percent Time Spent Between 70 and 180 mg/dL

  This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Daytime, defined as 7am-11pm.

  Daytime [7am - 11pm]

• Percent Time Spent Between 70 and 180 mg/dL

  This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Overnight, defined as 11pm-7am.

  Overnight [11pm - 7am]

• Percent Time Spent Between 70 and 180 mg/dL

  This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Skiing periods, defined as 9:30am-noon and 1:30pm-4pm.

  Skiing [9:30am-noon and 1:30pm-4pm]

Secondary Outcomes (45)

• Percent Time Spent <50 mg/dL

  Overall [48hr study admission]

• Percent Time Spent <54 mg/dL

  Overall [48hr study admission]

• Percent Time Spent <60 mg/dL

  Overall [48hr study admission]

• Percent Time Spent <70 mg/dL

  Overall [48hr study admission]

• Percent Time Spent >180 mg/dL

  Overall [48hr study admission]

Study Arms (2)

Artificial Pancreas Therapy

EXPERIMENTAL

Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia. In addition a Dexcom G5 Share/Follow system will be used to remote monitor the participants and ensure safety.

Device: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6; Device: Dexcom CGM G5

Sensor Augmented Pump Therapy

PLACEBO COMPARATOR

Subjects will use a Dexcom CGM G5 and their Continuous Subcutaneous Insulin Infusion devices (insulin pumps) to modulate their insulin delivery and control their glycemia. In addition a Dexcom G5 Share/Follow system will be used to remote monitor the participants and ensure safety.

Device: Dexcom CGM G5; Device: Continuous Subcutaneous Insulin Infusion

Interventions

Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 DEVICE

Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].

Also known as: Artificial Pancreas, Automated Insulin Delivery Device

Artificial Pancreas Therapy

Dexcom CGM G5 DEVICE

The Dexcom G5 CGM is a subcutaneous glucose sensor that provides an estimate of the prevailing blood glucose concentration approximately every 5 minutes.The Dexcom G5 sensor alerts the user if the prevailing glucose concentration is higher or lower than predetermined thresholds, or if it is changing too fast. In addition, the Share/Follow functionality of the Dexcom G5 allows up to 5 people ("followers") to receive in real-time information about the current blood glucose concentration and rate of change. The Dexcom G5 system will be used by participants and clinical study staff to monitor glucose levels 24h/day during the camp, ensure participants safety, and compute glycemic control outcomes

Also known as: Continuous Glucose monitoring

Artificial Pancreas Therapy; Sensor Augmented Pump Therapy

Continuous Subcutaneous Insulin Infusion DEVICE

Subjects will use a subcutaneous pump to deliver insulin and control their glycemia.

Also known as: Insulin pump

Sensor Augmented Pump Therapy

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Criteria for documented hyperglycemia (at least 1 must be met):
• Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required)
• The diagnosis of type 1 diabetes is based on the investigator's judgment
• Criteria for requiring insulin at diagnosis (both criteria must be met):
• Daily insulin therapy for ≥ 6 months
• Insulin pump therapy for ≥ 3 months (note: must be willing to disable any glucose suspend, predictive suspend, or artificial pancreas functionality on insulin pump during study)
• Virginia camp: age 13-18 years; Colorado/Stanford camps: 6-12 years
• 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
• Not being pregnant at the start of the trial. All female subjects of childbearing potential will be screened for pregnancy.
• \. If the participant is less than 13 years of age and the parents or the study team request it, at least one parent commit to stay with the study subject at the camp site 9. A parent/caregiver is available for system training and will commit to be the main responsible person for the use of the AP system at home

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
• History of altitude sickness
• Chronic pulmonary conditions that could impair oxygenation
• 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).
• Pregnancy
• Presence of a febrile illness within 24 hours of start ski camp or acetaminophen use while wearing the CGM. The camp 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 (for parent and/or child):
• Inpatient psychiatric treatment in the past 6 months

Sponsors & Collaborators

• University of Virginia: lead
• Tandem Diabetes Care, Inc.: collaborator
• DexCom, Inc.: collaborator

Study Sites (3)

Stanford University

Stanford, California, 94304, United States

Location

Barbara Davis Center, University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Ekhlaspour L, Forlenza GP, Chernavvsky D, Maahs DM, Wadwa RP, Deboer MD, Messer LH, Town M, Pinnata J, Kruse G, Kovatchev BP, Buckingham BA, Breton MD. Closed loop control in adolescents and children during winter sports: Use of the Tandem Control-IQ AP system. Pediatr Diabetes. 2019 Sep;20(6):759-768. doi: 10.1111/pedi.12867. Epub 2019 May 23.

  PMID: 31099946 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial; Continuous Glucose Monitoring; Insulin Infusion Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps

Limitations and Caveats

Data for 3 participants were excluded. Subject 1: a software error resulted in prolonged AP system downline. The error was identified in data analysis; Subject 2: repeated pump occlusion resulted in prolonged system downtime; Subject 3: study pump initialized with siblings pump settings resulting in strong biased results.

Results Point of Contact

• Title: Marc Breton, PhD
• Organization: University of Virginia Center for Diabetes Technology

mb6nt@virginia.edu

434-982-6484

Study Officials

• Marc Breton, PhD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: December 11, 2017
• Study Start: December 18, 2017
• Primary Completion: April 15, 2018
• Study Completion: April 15, 2018
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (3)