Type 1 Diabetes MellitusMDB005NCT01390259
Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System
A study testing Open-Loop and Closed-Loop in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Open-Loop and Closed-Loop
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
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
- Being tested
- Open-Loop, Closed-Loop
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-LoopDevice
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...).
Closed-LoopDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Closed Loop Control (CLC) | Experimental | 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. Receives: Device: Closed-Loop |
| Open Loop | Placebo comparator | The subject were in charge of their insulin treatment. Receives: Device: Open-Loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 22 hours
Secondary outcomes (2)
Percent Time in Euglycemia
Percent of time the patient plasma glucose as measured by YSI is between 70mg/dl and 180mg/dl
Measured: 22 hours
Mean Glucose
Average plasma glucose concentration in mg/dl
Measured: 22 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diabetes Care, DexCom, Inc., Insulet Corporation, University of California, Santa Barbara
- Responsible party
- Principal investigator, Marc Breton, University of Virginia
- Investigators
- Marc D. Breton, Ph.D., Principal investigator, University of Virginia, Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390259
- Sponsor's protocol ID
- 14758
- Acronym
- MDB005
- Status last verified
- Jul 2014
- First submitted
- 6 Jul 2011
- Last updated
- 15 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22688340
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System
- ClinicalTrials.gov ID
- NCT01390259
- Acronym / sponsor ID
- MDB005 / 14758
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Abbott Diabetes Care, DexCom, Inc., Insulet Corporation, University of California, Santa Barbara
- Study start
- Jan 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed Loop Control (CLC) | Experimental | Device: Closed-LoopThe 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. |
| Open Loop | Placebo comparator | Device: Open-LoopThe subject were in charge of their insulin treatment. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open-LoopThis 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...). | Device | Open Loop |
| Closed-LoopIn 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. | Device | Closed Loop Control (CLC) |
Primary outcome
Hypoglycemic Events
Time frame: 22 hours
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
2 secondary outcomes
Percent Time in Euglycemia
Time frame: 22 hours
Mean Glucose
Time frame: 22 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22688340Breton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc D. Breton, Ph.D. principal investigator
University of Virginia, Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open-Loop and Closed-Loop in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemic Events (time frame: 22 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01390259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014; AzTrials last refreshed its copy on 1 Nov 2026.