Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp

NCT ID: NCT03369067

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-18
• Study Completion Date: 2018-04-15

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. Phase 1 participants (13-18 years old) and Phase 2 participants (6-12 years old) will be assessed during a ~48 hour ski camp; Upon completion of the ski camp, Phase 2 participants (6-12 years old) will also be assessed during a ~78 hour home use.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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 \[CGM\].

Dexcom CGM G5

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Dexcom CGM G5

Intervention Type: 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

Continuous Subcutaneous Insulin Infusion

Intervention Type: DEVICE

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

Interventions

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 \[CGM\].

Intervention Type: 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

Intervention Type: DEVICE

Continuous Subcutaneous Insulin Infusion

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

Intervention Type: DEVICE

Other Intervention Names

Artificial Pancreas; Automated Insulin Delivery Device; Continuous Glucose monitoring; 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tandem Diabetes Care, Inc.

INDUSTRY

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Marc Breton

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc Breton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Center for Diabetes Technology

Locations

Stanford University

Stanford, California, United States

Barbara Davis Center, University of Colorado

Aurora, Colorado, United States

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 31099946 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20335

Identifier Type: -

Identifier Source: org_study_id