Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01390259
• Date of registration: 06/07/2011
• Primary sponsor: University of Virginia
• Public title: Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System MDB005
• Scientific title: Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System
• Date of first enrolment: January 2010
• Target sample size: 11
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01390259
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Countries of recruitment

United States

Contacts

• Name: Marc D. Breton, Ph.D.
• Affiliation: University of Virginia, Center for Diabetes Technology

Key inclusion & exclusion criteria

Inclusion Criteria:

- 12 years of age and up to and including 18 years of age.

- Have type 1 diabetes mellitus as defined by American Diabetes Association criteria or
judgment of physician for at least 1 year (including those who may also be treated
with metformin).

- Use of an insulin pump

- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have
stability on the medication for at least 2 months prior to enrollment in the study

- Willingness to use lispro (Humalog) insulin for the duration of the inpatient study

- Demonstration of proper mental status and cognition for the study

- Willingness to stop using any dietary supplements for two weeks prior to admission
and for the duration of their participation

- HemoglobinA1c < 10.0

- A score of 2 or greater on the hypoglycemia unawareness scale, see Attachment A

- Tanner Stage II or greater (not pre-pubertal) on screening physical exam

- Body weight of 30 kg or more at screening

- BMI must be under 95th percentile for age based on published BMI reference standards

Exclusion Criteria:

- - Age <12 or >18

- Pregnancy

- Hematocrit <37% (females); <36% (males)

- HemoglobinA1c = 10.0

- Any symptomatic coronary artery disease, or a history of congenital heart
abnormalities.

- Score of less than 2 on the hypoglycemia unawareness scale

- Tanner Stage I on screening physical exam

- Use of a medication that significantly lowers heart rate (beta blockers, reserpine,
guanethidine, methyldopa, clonidine, cimetidine, digitalis, calcium channel blockers,
amiodarone, antiarrythmic drugs, or lithium)

- Congestive heart failure

- History of a cerebrovascular event

- Use of a medication that significantly impacts glucose metabolism (oral steroids)

- Atrial fibrillation

- Uncontrolled hypertension (resting blood pressure >140/90)

- History of a systemic or deep tissue infection with methicillin-resistant staph
aureus or Candida albicans

- Use of a device that may pose electromagnetic compatibility issues and/or
radiofrequency interference with the FreeStyle NavigatorTM CGM or DexCom Seven®
(implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator,
intrathecal pump, and cochlear implants)

- Active enrollment in another clinical trial

- Allergy or adverse reaction to lispro insulin

- Known adrenal gland problem, pancreatic tumor, or insulinoma

- Current alcohol abuse by patient history, substance abuse by patient history, or
severe mental illness

- Retinopathy and renal failure

- Uncontrolled anxiety or panic disorder

- Known bleeding diathesis or dyscrasia

- Renal insufficiency (creatinine >1.5)

- Any comorbid condition affecting glucose metabolism

- Body weight of less than 30 kg at screening

- BMI equal to or greater than 95th percentile for age based on published BMI reference
standards. See Appendix B.

- Asthma or exercise -induced asthma

- Any mobility-restrictive condition

- Children who are wards of state or at high risk for becoming wards of state



Age minimum: 12 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Device: Closed-Loop

Device: Open-Loop

Primary Outcome(s)

Number of hypoglycemic events below 70 mg/dL per patient per day [Time Frame: 24h]

Secondary Outcome(s)

Mean glucose [Time Frame: 24h]

Percent time in euglycemia [Time Frame: 24h]

Secondary ID(s)

14758

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott Diabetes Care

DexCom, Inc.

Insulet Corporation

University of California, Santa Barbara