Type 1 DiabetesPhase 2NCT00797823

Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone

A Phase 2 study testing Insulin, Asp(B28)- and Glucagon in people with Type 1 Diabetes, 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 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Insulin, Asp(B28)- and Glucagon
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Sep 2009
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 21-65, history of Type 1 Diabetes Mellitus for > 3 months.
Women:
For women of childbearing potential, a negative urine pregnancy test is required on the first day of the study prior to sensor insertion AND the subject must agree to use contraception prior to and during the study.
For menopausal women or those who have undergone surgical sterilization, no pregnancy test or contraception will be required.
Willingness to attend all clinic visits and participate in two 28-hour studies or one 9-hour study.
Hemoglobin A1C of 5.0-10%. (Values below 5.0 suggest a severe tendency towards hypoglycemia, and values above 10% suggest severely uncontrolled diabetes with risk for ketoacidosis.)
Body mass index of 19-35.

Who cannot join

Pregnancy, lactation or refusal to use contraception.
Use of any investigational drug during the 30 days prior to screening.
Enrollment or participation in any other research studies 30 days prior to and during the entirety of sensor insertion.
Current alcohol abuse, substance abuse, or severe mental illness (as judged by the Principal Investigator (PI)).
Any prior cerebrovascular accident or major permanent neurological damage such as aphasia, hemiparesis, or dementia.
A history of cerebrovascular disease or cardiovascular disease regardless of the time since occurrence.

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Coronary artery disease (symptomatic or asymptomatic) as manifested by unstable angina, acute coronary syndrome, myocardial infarction or therapeutic coronary procedure (e.g., Percutaneous Transluminal Coronary Angioplasty (PTCA), stent placement, Coronary Artery By-pass Grafting (CABG)) within the prior 6 months.
Any degree of heart failure (as defined by New York Heart Association)..
Renal insufficiency (serum creatinine of > 2.5).
Current foot or leg ulceration.
Peripheral arterial disease with uncontrolled claudication.
Active uncontrolled malignancy except basal cell or squamous cell skin cancers.
Concurrent illness, other than diabetic mellitus, that is not controlled by a stable therapeutic regimen.
Hemoglobin A1C of less than 5.0 or greater than 10%.
A total bilirubin level above 1.5 mg/dl.
Medications: Oral or parenteral corticosteroids (glucocorticoid therapy) are exclusions; topical corticosteroids are not.
Any chronic immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
Visual impairment that would prevent reading the display of the Medtronic Guardian® Receiver.
Physical impairment that would prevent using the buttons of the Medtronic Guardian® Receiver.
Serum Alanine Transaminase (ALT) or Aspartate Transaminase (AST) ≥3x the upper limit of normal.
Serum albumin level of < 3.2 g/dl.
Severe anemia as defined by a hematocrit of < 28%.
Severe serum electrolyte abnormality (sodium, potassium, carbon dioxide, chloride).
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.
A history of Human Immunodeficiency Virus (HIV) infection.
An active hepatitis infection.
Known allergy to any type of insulin
Insulin resistance requiring more than 200 units of insulin per day
Known bleeding disorders or chronic usage of warfarin.
Any known seizure disorder.
Past history of pheochromocytoma or a family history of Multiple Endocrine Neoplasia (MEN) 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease.
Hypoglycemic unawareness or chronic hypoglycemia.
A severe hypoglycemic event which required hospitalization within the past two years.
Adrenal insufficiency.
Insulinoma.
Use of both acetaminophen and ascorbic acid.
Impaired mentation or psychiatric diagnoses
Uncontrolled candidiasis.
Any known allergy to glucagon.

Trial locations and contacts

1 site in 1 country.

United States1 site

Legacy Research
Portland, Oregon, 97232

Other trials in United States

About this study

Official title: A Comparison of Two Sensor-Augmented Glycemic Control Systems in Persons With Type 1 Diabetes Mellitus: Subcutaneous (SC) Insulin and Glucagon Delivery vs. SC Insulin Only

This study aims to test an insulin and glucagon delivery algorithm designed to be used in conjunction with a continuous glucose monitoring system. This combined glucose sensing/hormone delivery approach is a step on the way to eventual development of an artificial (or automated) pancreas. The insulin and glucagon delivery algorithm is based on the difference between the current blood glucose and the target glucose (proportional error) and the rate of change in blood glucose (derivative error), both adjusted for the recent glucose history. This algorithm is called the Fading Memory Proportional-Derivative (FMPD) Algorithm. The principal investigator of this study has published previous research regarding the use of this algorithm and found it to be well-suited to control blood glucose in type 1 diabetic animals. The addition of glucagon was helpful; better glycemic control with fewer glucose excursions were observed when small intermittent infusions of subcutaneous glucagon were given during times of impending low blood sugar (Ward et al. 2008).

Read the detailed description

The objective of the current human study is to compare glycemic control in persons with Type 1 Diabetes using the FMPD Insulin plus Glucagon Delivery Algorithm vs. the FMPD Insulin-Alone Algorithm. Subjects will undergo two 28-hour sensor-augmented glycemic control studies. Each subject will be fitted with two short term continuous glucose monitoring systems and two subcutaneous (SC) infusion catheters. These catheters will allow for SC delivery of insulin and glucagon (or insulin plus a glucagon placebo). The accuracy of the wire sensors will be verified every 10 minutes with a venous blood glucose test. For the first 4 hours, the insulin and glucagon delivery will be controlled by venous blood in order to assess and compare the accuracy of the two sensors, after which the more accurate sensor (if it remains accurate) will control the FMPD algorithm. The main outcomes of our study are time spent in the target range (70 - 180 mg/dl) and the percentage of studies requiring intervention due to hypoglycemia (glucose < 70 mg/dl). The accuracy of the sensors over the life of the study will also be evaluated.

The specific system used in this study of frequent blood testing and the use of two separate infusion pumps is not feasible for every day use for individuals with diabetes. However, if the glucose control algorithm (with or without the use of glucagon) provides effective blood glucose management over long time periods the calculation program may be integrated into a continuous blood glucose monitoring system with an insulin and glucagon pump.

Conditions: Type 1 Diabetes
Being tested: Insulin, Asp(B28)-, Glucagon, Placebo
Keywords: diabetes, pancreas, beta cell, glucagon, insulin, hypoglycemia
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance, Hypoglycemia

What participants receive

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

Insulin, Asp(B28)-Drug
Also called Aspart insulin, Novolog
Insulin dosing and frequency calculated by Fading Memory Proportional Derivative algorithm
GlucagonDrug
Also called Glucagen
During incipient hypoglycemia, glucagon was given in an attempt to prevent overt hypoglycemia. Dosing and frequency was calculated by the Fading Memory Proportional Derivative algorithm
PlaceboDrug
Also called Normal saline, NaCl 0.9%
Saline solution 0.9%

Study groups in NCT00797823
Study group	Role	What they receive
Insulin + Placebo	Placebo comparator	Glycemic control of subject participants was managed by the closed-loop system which delivered insulin and normal saline (instead of glucagon) as a placebo, based upon algorithm calculations. Receives: Drug: Insulin, Asp(B28)-; Drug: Placebo
Insulin + Glucagon	Active comparator	Glycemic control of subject participants was managed by the system which delivered insulin and glucagon based upon algorithm calculations. Receives: Drug: Insulin, Asp(B28)-; Drug: Glucagon
Pilot Study	Experimental	Pilot studies designed to assess safety of the system. Includes 6 participants undergoing 7 studies. Receives: Drug: Insulin, Asp(B28)-; Drug: Glucagon; Drug: Placebo

What is being measured

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

Effectiveness of Closed Loop Diabetes Control
Effectiveness of closed loop diabetes control will be measured by mean glucose.
Measured: 1 year

Secondary outcomes (1)

Percent of Time Venous Blood Glucose <70 mg/dl
Measured: 1 year

Timeline

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

Nov 2008Sep 2009

First posted25 Nov 2008 (estimated)
Study startNov 2008
Primary completionSep 2009
Study completionSep 2009

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.
Other trials for Type 1 DiabetesStudies 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: NCT00797823
Sponsor's protocol ID: IRB4311
Status last verified: Aug 2009
First submitted: 24 Nov 2008
Last updated: 7 Oct 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Two Sensor-Augmented Glycemic Control Systems in Persons With Type 1 Diabetes Mellitus: Subcutaneous (SC) Insulin and Glucagon Delivery vs. SC Insulin Only
ClinicalTrials.gov ID: NCT00797823
Acronym / sponsor ID: IRB4311
Conditions: Type 1 Diabetes
Keywords: diabetes, pancreas, beta cell, glucagon, insulin, hypoglycemia
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, Oregon Health and Science University
Study start: Nov 2008
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 25 Nov 2008 (estimated)
Results: Posted 26 Sep 2011

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Insulin + Placebo	Placebo comparator	Drug: Insulin, Asp(B28)-, Drug: PlaceboGlycemic control of subject participants was managed by the closed-loop system which delivered insulin and normal saline (instead of glucagon) as a placebo, based upon algorithm calculations.
Insulin + Glucagon	Active comparator	Drug: Insulin, Asp(B28)-, Drug: GlucagonGlycemic control of subject participants was managed by the system which delivered insulin and glucagon based upon algorithm calculations.
Pilot Study	Experimental	Drug: Insulin, Asp(B28)-, Drug: Glucagon, Drug: PlaceboPilot studies designed to assess safety of the system. Includes 6 participants undergoing 7 studies.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 21-65, history of Type 1 Diabetes Mellitus for > 3 months.
Women:
Willingness to attend all clinic visits and participate in two 28-hour studies or one 9-hour study.
Hemoglobin A1C of 5.0-10%. (Values below 5.0 suggest a severe tendency towards hypoglycemia, and values above 10% suggest severely uncontrolled diabetes with risk for ketoacidosis.)
Body mass index of 19-35.

Key exclusion criteria (39 listed)

Pregnancy, lactation or refusal to use contraception.
Use of any investigational drug during the 30 days prior to screening.
Enrollment or participation in any other research studies 30 days prior to and during the entirety of sensor insertion.
Current alcohol abuse, substance abuse, or severe mental illness (as judged by the Principal Investigator (PI)).
Any prior cerebrovascular accident or major permanent neurological damage such as aphasia, hemiparesis, or dementia.

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
Insulin, Asp(B28)-Also: Aspart insulin, NovologInsulin dosing and frequency calculated by Fading Memory Proportional Derivative algorithm	Drug	Insulin + Glucagon, Insulin + Placebo, Pilot Study
GlucagonAlso: GlucagenDuring incipient hypoglycemia, glucagon was given in an attempt to prevent overt hypoglycemia. Dosing and frequency was calculated by the Fading Memory Proportional Derivative algorithm	Drug	Insulin + Glucagon, Pilot Study
PlaceboAlso: Normal saline, NaCl 0.9%Saline solution 0.9%	Drug	Insulin + Placebo, Pilot Study

Primary outcome

Effectiveness of Closed Loop Diabetes Control
Time frame: 1 year
Effectiveness of closed loop diabetes control will be measured by mean glucose.

1 secondary outcome

Percent of Time Venous Blood Glucose <70 mg/dl
Time frame: 1 year

Results and safety

Results posted to the registry on 26 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin + Glucagon -> Insulin + Placebo)	0	0
Insulin + Placebo -> Insulin + Glucagon	0	0
Pilot	6	6

Primary outcome: Effectiveness of Closed Loop Diabetes Control

Time frame: 1 year. Mean (Standard Error). Unit: mg/dl

Measure	Placebo Comparator: Insulin Alone n = 8	Active Comparator: Insulin Plus Glucagon n = 13
Value	136.9 (5.0)	149.5 (5.5)

Population analysed: The number of participants for analysis was determined was per protocol.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Over 1 year for entire research period, and over the study period for each individual study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin + Glucagon -> Insulin + Placebo)	0 of 4 (0%)	4 of 4 (100%)	Not reported
Insulin + Placebo -> Insulin + Glucagon	0 of 4 (0%)	4 of 4 (100%)	Not reported
Pilot	0 of 6 (0%)	1 of 6 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

William K. Ward, MD principal investigator

Legacy Health System

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Insulin, Asp(B28)- and Glucagon in people with Type 1 Diabetes, run by Legacy Health System 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 7 inclusion and 39 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 7 Oct 2011. 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.

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 26 Sep 2011). 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?

Effectiveness of Closed Loop Diabetes Control (time frame: 1 year). 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 NCT00797823.

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 7 Oct 2011; AzTrials last refreshed its copy on 4 Nov 2026.