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

NCT ID: NCT01390259

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-02-28

Brief Summary

In this protocol the investigators plan to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The protocol is designed to challenge the insulin management system with meals and mild exercise, so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic state. This system is designed to both

• monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
• predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.

The investigators plan to enroll 12 adolescent T1DM patients (expected retention 10/12) and compare glucose control performances under two treatments: standard vs. the new insulin management system. The protocol will include a total of 5 admissions per subject (3 out-patients and 2 in-patients): screening, CGM insertion 1, CGM insertion 2, inpatient 1 and inpatient 2. During the 24h inpatient admissions the patients will be challenged with 30 minutes of mild exercise and 3 meals, insulin coverage of these events will vary depending on the chosen treatment, each subject will be exposed to both studied treatments (repeated measure design). The order of treatment during the inpatient admissions will be randomized.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Closed Loop Control (CLC)

The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:

• monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
• predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.

Group Type: EXPERIMENTAL

Closed-Loop

Intervention Type: DEVICE

In this study, the researchers compared the management of diabetes during physical activity and meals with the closed-loop system developed at the University of Virginia. This system uses two DexComTM Seven Continuous Glucose Monitor, a computer containing an investigational control algorithm (well-defined instructions that are expressed in mathematical equations), and an OmniPod Insulin Management System, a portable subcutaneous (under the skin) insulin pump. During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. The study included a challenge to the insulin management system with meals and mild exercise, so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic state.

Open Loop

The subject were in charge of their insulin treatment.

Group Type: PLACEBO_COMPARATOR

Open-Loop

Intervention Type: DEVICE

This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).

Interventions

Open-Loop

This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).

Intervention Type: DEVICE

Closed-Loop

In this study, the researchers compared the management of diabetes during physical activity and meals with the closed-loop system developed at the University of Virginia. This system uses two DexComTM Seven Continuous Glucose Monitor, a computer containing an investigational control algorithm (well-defined instructions that are expressed in mathematical equations), and an OmniPod Insulin Management System, a portable subcutaneous (under the skin) insulin pump. During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. The study included a challenge to the insulin management system with meals and mild exercise, so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic state.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Diabetes Care

INDUSTRY

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Insulet Corporation

INDUSTRY

Sponsor Role: collaborator

University of California, Santa Barbara

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Marc Breton

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc D. Breton, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Virginia, Center for Diabetes Technology

Locations

University of Virginia Health System

Charlottesville, Virginia, United States

Countries

United States

References

Breton M, Farret A, Bruttomesso D, Anderson S, Magni L, Patek S, Dalla Man C, Place J, Demartini S, Del Favero S, Toffanin C, Hughes-Karvetski C, Dassau E, Zisser H, Doyle FJ 3rd, De Nicolao G, Avogaro A, Cobelli C, Renard E, Kovatchev B; International Artificial Pancreas Study Group. Fully integrated artificial pancreas in type 1 diabetes: modular closed-loop glucose control maintains near normoglycemia. Diabetes. 2012 Sep;61(9):2230-7. doi: 10.2337/db11-1445. Epub 2012 Jun 11.

Reference Type: RESULT

PMID: 22688340 (View on PubMed)

Other Identifiers

14758

Identifier Type: -

Identifier Source: org_study_id