Type 1 Diabetes MellitusPhase 2NCT01261052

Real-time Adaptation to Changes in Insulin Sensitivity

A Phase 2 study testing The Fading Memory Proportional Derivative/Adaptive Proportional Derivative Algorithm and The Adaptive Proportional Derivative Algorithm in people with Type 1 Diabetes Mellitus, run by Legacy Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Type 1 Diabetes Mellitus
What is being tested?: The Fading Memory Proportional Derivative/Adaptive Proportional Derivative Algorithm and The Adaptive Proportional Derivative Algorithm
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Nov 2010to Apr 2011
Phase: Phase 2
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 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Diagnosis of Type 1 Diabetes Mellitus for at least 1 year
Male or Female subjects 21 to 65 years of age
Willingness to follow all study procedures, including attending all clinic visits
Willingness to sign informed consent and HIPAA documents.

Who cannot join

Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.3 g/dL; or serum bilirubin of over 2.
Adrenal insufficiency
Hematocrit of less than or equal to 34%.
A history of cerebrovascular disease or coronary artery disease regardless of the time since occurrence.

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Congestive heart failure, NYHA class III or IV.
Cardiac rhythm disturbance characterized by: 2nd or 3rd degree heart block, bradycardia of less than 50 bpm (exception of bradycardia in an aerobic athlete), tachycardia of greater than 100 bpm, or any arrhythmia judged by the investigator to be exclusionary.
Any active infection.
Visual impairment preventing reading of glucose meter values or continuous glucose monitoring device.
Physical impairment impeding the ability to use a glucose meter or glucose monitoring device.
Active foot ulceration.
Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator).
Active malignancy, except basal cell or squamous cell skin cancers.
Major surgical operation within 30 days prior to screening.
Seizure disorder.
Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
Current administration of oral or parenteral corticosteroids.
Use of an investigational drug within 30 days prior to screening.
Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
History of major non-compliance.
Allergy to aspart insulin.
Allergy to glucagon.
Past history of pheochromocytoma or a family history of MEN 2, neurofibromatosis, or von Hippel-Lindau disease.
Insulin resistance requiring more than 200 units per day.
Need for uninterrupted treatment of acetaminophen.
Intolerance of mild hypoglycemia (glucose 60-70 mg/dl).
Patients using all dietary supplements (except for vitamin supplements, calcium or vitamin D in standard doses).
Patients with a history of glaucoma or who have not had an ophthalmologic exam in the previous 2 years (because of the risk of increased intraocular pressure)
Patients with a history of psychiatric disease or steroid-induced psychosis.
Patients currently on estrogen supplementation (low dose estrogen contraceptives are not exclusionary).
Chronic use of dietary supplements that contain adrenal cell extracts, adrenal cortical extracts, or other hormones.
The use of dietary supplements (except for vitamin supplements, calcium or vitamin D in standard doses) will be exclusionary (unless the subjects agrees to abstain from taking such supplements for three weeks before beginning the study.
Administration of an immunization (such as a flu or travel immunization) or plans to receive such an immunization within one week of beginning of the study.
Any reason the principal investigator deems exclusionary.

Trial locations and contacts

1 site in 1 country.

United States1 site

Legacy Good Samaritan Hospital
Portland, Oregon, 97210

Other trials in United States

About this study

Official title: Sensor-Controlled Insulin and Glucagon Delivery in Subjects With Type 1 Diabetes: Real-time Adaptation to Changes in Insulin Sensitivity

The purpose of this research study is to test an automated blood glucose control system that includes a new component designed to adapt to stress. The importance of this component is that when Type 1 Diabetics are stressed (for example, from illness or infection), their body is resistant to the effects of insulin. The investigators will be adjusting their blood glucose using insulin and glucagon and making their body less sensitive to insulin with a steroid, hydrocortisone. Insulin is a hormone that lowers blood glucose. Glucagon raises blood glucose when it is low. Both are natural hormones made by people without diabetes. Hydrocortisone is a steroid that will increase their blood glucose temporarily and will be given every 4 hours. All subjects will participate in two 33 hour experiments. One experiment will use the adaptive version of the sensor-based glucose control system. The other study will use the original version of the control system, without the adaptive component, for the first 13 hours. Then, the adaptive component will be added to the glucose control system for the remaining 20 hours of the study. Our primary goal is to assess the effectiveness of the adaptive component to control glucose levels in the presence of steroid-induced insulin resistance in persons with Type 1 Diabetes Mellitus.

Conditions: Type 1 Diabetes Mellitus
Being tested: The Fading Memory Proportional Derivative/Adaptive Proportional Derivative Algorithm, The Adaptive Proportional Derivative Algorithm
Keywords: glucose sensors, artificial pancreas, Diabetes Mellitus
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Fading Memory Proportional Derivative/Adaptive Proportional Derivative AlgorithmDevice
The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The "fading memory" designation refers to weighting recent errors more heavily than remote errors.
The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin.
The Adaptive Proportional Derivative AlgorithmDevice
The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The "fading memory" designation refers to weighting recent errors more heavily than remote errors.
The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin.

Study groups in NCT01261052
Study group	Role	What they receive
FMPD/APD intervention	Active comparator	Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. Receives: Device: The Fading Memory Proportional Derivative/Adaptive Proportional Derivative Algorithm
APD only intervention	Active comparator	Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For the entire study, the adaptive component or APD will be used to control the subject's blood glucose. Receives: Device: The Adaptive Proportional Derivative Algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of the Effectiveness of APD and FMPD/APD Intervention in Adapting to Reduced Insulin Sensitivity
The effectiveness of the APD and FMPD/APD intervention in adapting to reduced insulin sensitivity was analyzed using mean glucose.
Measured: all 33 hour studies

Secondary outcomes (1)

Measurement of APD and FMPD/APD Interventions in Controlling Post-prandial Blood Glucose With Reduced Insulin Sensitivity.
Assessment of control of post prandial hyperglycemia with APD and FMPD/APD interventions using mean post-prandial glucose (3 hours after meals).
Measured: all 33 hour studies

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Apr 2011

First posted16 Dec 2010 (estimated)
Study startNov 2010
Primary completionApr 2011
Study completionApr 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01261052
Sponsor's protocol ID: 2010.005
Status last verified: Nov 2012
First submitted: 15 Dec 2010
Last updated: 3 Dec 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Castle JR, Engle JM, El Youssef J, Massoud RG, Yuen KC, Kagan R, Ward WK. Novel use of glucagon in a closed-loop system for prevention of hypoglycemia in type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1282-7. doi: 10.2337/dc09-2254. Epub 2010 Mar 23.
PubMed 20332355

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sensor-Controlled Insulin and Glucagon Delivery in Subjects With Type 1 Diabetes: Real-time Adaptation to Changes in Insulin Sensitivity
ClinicalTrials.gov ID: NCT01261052
Acronym / sponsor ID: 2010.005
Conditions: Type 1 Diabetes Mellitus
Keywords: glucose sensors, artificial pancreas, Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Legacy Health SystemUniversity, hospital or other
Collaborators: Juvenile Diabetes Research Foundation
Study start: Nov 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 16 Dec 2010 (estimated)
Results: Posted 29 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
FMPD/APD intervention	Active comparator	Device: The Fading Memory Proportional Derivative/Adaptive Proportional Derivative AlgorithmType 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours.
APD only intervention	Active comparator	Device: The Adaptive Proportional Derivative AlgorithmType 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For the entire study, the adaptive component or APD will be used to control the subject's blood glucose.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of Type 1 Diabetes Mellitus for at least 1 year
Male or Female subjects 21 to 65 years of age
Willingness to follow all study procedures, including attending all clinic visits
Willingness to sign informed consent and HIPAA documents.

Key exclusion criteria (37 listed)

Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.3 g/dL; or serum bilirubin of over 2.
Adrenal insufficiency
Hematocrit of less than or equal to 34%.

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
The Fading Memory Proportional Derivative/Adaptive Proportional Derivative AlgorithmThe APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The "fading memory" designation refers to weighting recent errors more heavily than remote errors. The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin.	Device	FMPD/APD intervention
The Adaptive Proportional Derivative AlgorithmThe APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The "fading memory" designation refers to weighting recent errors more heavily than remote errors. The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin.	Device	APD only intervention

Primary outcome

Measurement of the Effectiveness of APD and FMPD/APD Intervention in Adapting to Reduced Insulin Sensitivity
Time frame: all 33 hour studies
The effectiveness of the APD and FMPD/APD intervention in adapting to reduced insulin sensitivity was analyzed using mean glucose.

1 secondary outcome

Measurement of APD and FMPD/APD Interventions in Controlling Post-prandial Blood Glucose With Reduced Insulin Sensitivity.
Time frame: all 33 hour studies

Results and safety

Results posted to the registry on 29 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	14	14

Primary outcome: Measurement of the Effectiveness of APD and FMPD/APD Intervention in Adapting to Reduced Insulin Sensitivity

Time frame: all 33 hour studies. Mean (Standard Deviation). Unit: mg/dl

Measure	All Study Participants n = 14
APD intervention	176 (64)
FMPD intervention	195 (69)

Population analysed: The number of participants for analysis was determined by an intention to treat (ITT) analysis based on the initial treatment assignment

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected for 6 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
APD Only Intervention	0 of 14 (0%)	1 of 14 (7.1%)	Not reported
FMPD/APD Intervention	0 of 14 (0%)	0 of 14 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20332355Castle JR, Engle JM, El Youssef J, Massoud RG, Yuen KC, Kagan R, Ward WK. Novel use of glucagon in a closed-loop system for prevention of hypoglycemia in type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1282-7. doi: 10.2337/dc09-2254. Epub 2010 Mar 23.

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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.

W K Ward, MD principal investigator

Legacy Health Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 37 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 3 Dec 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2012). 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?

Measurement of the Effectiveness of APD and FMPD/APD Intervention in Adapting to Reduced Insulin Sensitivity (time frame: all 33 hour studies). 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 NCT01261052, 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 3 Dec 2012; AzTrials last refreshed its copy on 1 Nov 2026.