Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp

Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth With Type 1 Diabetes: The AP Ski Camp Continued

Sponsors

Lead Sponsor: University of Virginia

Collaborator: Tandem Diabetes Care, Inc.
DexCom, Inc.
University of Virginia Strategic Investment Fund

Source 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.

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.

Overall Status Completed
Start Date December 18, 2017
Completion Date April 15, 2018
Primary Completion Date April 15, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent time spent in glycemic zone (70-180mg/dl) up to 48 hours
Enrollment 55
Condition
Intervention

Intervention Type: Device

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

Description: 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].

Arm Group Label: Artificial Pancreas Therapy

Intervention Type: Device

Intervention Name: Dexcom CGM G5

Description: 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

Intervention Type: Device

Intervention Name: Continuous Subcutaneous Insulin Infusion

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

Arm Group Label: Sensor Augmented Pump Therapy

Other Name: Insulin pump

Eligibility

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

Gender: All

Minimum Age: 6 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Marc Breton, PhD Principal Investigator University of Virginia Center for Diabetes Technology
Location
Facility:
Stanford University | Stanford, California, 94304, United States
Barbara Davis Center, University of Colorado | Aurora, Colorado, 80045, United States
University of Virginia Center for Diabetes Technology | Charlottesville, Virginia, 22903, United States
Location Countries

United States

Verification Date

August 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Virginia

Investigator Full Name: Marc Breton

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Artificial Pancreas Therapy

Type: Experimental

Description: 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.

Label: Sensor Augmented Pump Therapy

Type: Placebo Comparator

Description: 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.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov