Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03369067
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
Tandem Diabetes Care, Inc.
DexCom, Inc.
University of Virginia Strategic Investment Fund
Information provided by (Responsible Party):
Marc Breton, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 Device: Dexcom CGM G5 Device: Continuous Subcutaneous Insulin Infusion Not Applicable

Detailed Description:
This proposal aims to demonstrate the superiority of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named Tandem t:slim X2 with Control-IQ Technology and assess usability in a supervised setting in a controlled environment compared with state-of-the-art Sensor-Augmented Pump (SAP) therapy for the treatment of type 1 diabetes (T1D) in adolescents.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth With Type 1 Diabetes: The AP Ski Camp Continued
Actual Study Start Date : December 18, 2017
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Artificial Pancreas Therapy
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
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].
Other Names:
  • Artificial Pancreas
  • Automated Insulin Delivery Device

Device: Dexcom CGM G5

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

Other Name: Continuous Glucose monitoring

Placebo Comparator: Sensor Augmented Pump Therapy
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

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

Other Name: Continuous Glucose monitoring

Device: Continuous Subcutaneous Insulin Infusion
Subjects will use a subcutaneous pump to deliver insulin and control their glycemia.
Other Name: Insulin pump




Primary Outcome Measures :
  1. Percent time spent in glycemic zone (70-180mg/dl) [ Time Frame: up to 48 hours ]
    Primary outcome will be the percent time spent in desirable glycemic zone (70-180mg/dl) during the entirety of the camp.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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)
  3. Virginia camp: age 13-18 years; Colorado/Stanford camps: 6-12 years
  4. Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
  5. Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
  6. Not being pregnant at the start of the trial. All female subjects of childbearing potential will be screened for pregnancy.

8. 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

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. History of altitude sickness
  6. Chronic pulmonary conditions that could impair oxygenation
  7. Cystic fibrosis
  8. 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.
  9. History of ongoing renal disease (other than microalbuminuria).
  10. Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
  11. Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
  12. Pregnancy
  13. 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.
  14. 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
    • Uncontrolled adrenal insufficiency
    • Alcohol abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369067


Locations
Layout table for location information
United States, California
Stanford University
Stanford, California, United States, 94304
United States, Colorado
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States, 80045
United States, Virginia
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Tandem Diabetes Care, Inc.
DexCom, Inc.
University of Virginia Strategic Investment Fund
Investigators
Layout table for investigator information
Principal Investigator: Marc Breton, PhD University of Virginia Center for Diabetes Technology
Layout table for additonal information
Responsible Party: Marc Breton, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT03369067    
Other Study ID Numbers: 20335
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Marc Breton, University of Virginia:
Artificial Pancreas (AP)
Continuous Glucose Monitor (CGM)
Closed Loop Control (CLC)
Insulin Pump
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs