Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp

September 17, 2018 updated by: Daniel Chernavvsky, MD, CRC
The biggest challenges for glycemic control during the day time involve meals and exercise variations, which are impacted by age, fitness level, duration, intensity and history of exercise. Meal variability has the benefit that meals are typically announced and quantified. Glucose control around exercise, on the other hand, is more complicated if the patient doesn't announce a change in activity level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The object of this study is to evaluate the Closed-Loop Control (CLC) in an environment where muscle glycogen is systematically depleted, glucose uptake systematically increased, and meal sizes are naturally larger than normal: a week of camp at high altitude, with the concomitant variable of oxygen consumption that this environment involves; during the winter, that will expose and challenge the different components of the system during cold temperatures, and with twice daily practice of physical activity designed to deplete glycogen reserves such as skiing.

This proposal aims to demonstrate the superiority of the CLC, also known as Artificial Pancreas (AP), compared to the state-of-the art system available on the market: Sensor-augmented pump (SAP). This system has shown to diminish hypoglycemic events by setting the alarms on the continues glucose monitor (CGM) and taken action, such as performing self-monitoring blood glucose (SMBG) and treating if it is confirm to be low.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Denver, Barbara Davis Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: To be eligible for the study, a subject must meet the following:

  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 ≥ 12 months
    • Insulin pump therapy for ≥ 3 months
  3. Age 10 - 25 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. Female subjects who are sexually active must be on acceptable method of contraception (e.g. oral contraceptive pill, diaphragm, IUD)

Exclusion Criteria: The presence of any of the following is an exclusion for the study:

  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. Sexually active females who do not practice acceptable contraceptive methods to prevent pregnancy.
  14. 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.

  15. 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
    • Alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Closed-Loop Control (CLC) System
Subjects will use the Closed-Loop Control system in an attempt to maintain blood glucose in a certain range during the day and at night during the trial.
Device: Closed-Loop Control
Subjects will use the CLC during 5 nights/6 days at a ski camp.
Other Names:
  • CLC
Placebo Comparator: Sensor Augmented Pump Therapy Group
Subjects will manage their own glucose levels during the trial.
Other: Sensor Augmented Pump Therapy
Subjects using their personal pumps with study CGM.
Other Names:
  • SAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time in range when using closed-loop compared with SAP.
Time Frame: 120-144 hours
120-144 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of hypoglycemia episodes when using closed-loop
Time Frame: 120-144 hours
assessed by the number of hypoglycemia treatments were needed for each group
120-144 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Chernavvsky, MD, CRC

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
DexCom, Inc.

Investigators

  • Principal Investigator: Daniel R. Chernavvsky, MD, CRC, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18529
  • DP3DK106826-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

undetermined

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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