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Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System (MDB005)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open-Loop
Closed-Loop
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes Mellitus

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Closed Loop Control (CLC)

Open Loop

Arm Description

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.

The subject were in charge of their insulin treatment.

Outcomes

Primary Outcome Measures

Hypoglycemic Events
Number of hypoglycemic events below 70 mg/dL per patient per day Hypoglycemic event is defined as consecutive YSI plasma glucose measurements below 70 or moderate hypoglycemic symptoms

Secondary Outcome Measures

Percent Time in Euglycemia
Percent of time the patient plasma glucose as measured by YSI is between 70mg/dl and 180mg/dl
Mean Glucose
Average plasma glucose concentration in mg/dl

Full Information

First Posted
July 6, 2011
Last Updated
July 24, 2014
Sponsor
University of Virginia
Collaborators
Abbott Diabetes Care, DexCom, Inc., Insulet Corporation, University of California, Santa Barbara
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1. Study Identification

Unique Protocol Identification Number
NCT01390259
Brief Title
Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System
Acronym
MDB005
Official Title
Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Abbott Diabetes Care, DexCom, Inc., Insulet Corporation, University of California, Santa Barbara

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closed Loop Control (CLC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Open Loop
Arm Type
Placebo Comparator
Arm Description
The subject were in charge of their insulin treatment.
Intervention Type
Device
Intervention Name(s)
Open-Loop
Intervention Description
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
Intervention Name(s)
Closed-Loop
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hypoglycemic Events
Description
Number of hypoglycemic events below 70 mg/dL per patient per day Hypoglycemic event is defined as consecutive YSI plasma glucose measurements below 70 or moderate hypoglycemic symptoms
Time Frame
22 hours
Secondary Outcome Measure Information:
Title
Percent Time in Euglycemia
Description
Percent of time the patient plasma glucose as measured by YSI is between 70mg/dl and 180mg/dl
Time Frame
22 hours
Title
Mean Glucose
Description
Average plasma glucose concentration in mg/dl
Time Frame
22 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc D. Breton, Ph.D.
Organizational Affiliation
University of Virginia, Center for Diabetes Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22688340
Citation
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.
Results Reference
result

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

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