Diabetes Mellitus, Type 1NCT02536950
An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
A study testing Fixed set point and Variable set point in people with Diabetes Mellitus, Type 1, run by Bruce A. Buckingham at 1 site in United States.
Trial summary
This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Fixed set point and Variable set point
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes for at least 1 year
- insulin pump for ≥ 6 months
- Prescription medication regimen stable for > 1 month
- Subject comprehends written English
- Female patients who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD (Intrauterine Device)
- Female patients must have a negative urine pregnancy test
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- Informed Consent Form signed by the subject
- Lives and works within a 60 minute drive-time radius of Stanford University
- Willing to remain within a 60 minute drive-time radius of Stanford University during all 3 of the 7-day study arms (21 days)
- Have someone over 18 years of age who lives with them,
Who cannot join
- Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)
- Subject has a history of diagnosed medical eating disorder
- Subject has a history of visual impairment which would not allow subject to participate
- Subject has an active skin condition that would affect sensor placement
- Subject has adhesive allergies
- Subjects requiring an intermediate or long-acting insulin (such as NPH, Neutral Protamine Hagedorn, detemir or glargine)
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- Subjects requiring other anti-diabetic medications other than insulin (oral or injectable)
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more than 4 drinks in a day or use of marijuana during the trial
- Subject has active Graves' disease
- Subjects with inadequately treated thyroid disease or celiac disease
- History of liver disease Renal failure on dialysis
- Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease besides type 1 diabetes
- Any known history of coronary artery disease
- Abnormal EKG (electrocardiogram) consistent with coronary artery disease or increased risk of malignant arrhythmia
- Congestive heart failure (established history of congestive heart failure , lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea)
- History of transient ischemic attack (TIA) or stroke
- Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants
- History of hypoglycemic seizures (grand-mal) or coma in the last year
- History of pheochromocytoma:
- episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension
- paroxysms of tachycardia, pallor, or headache
- personal or family history of MEN 2A (multiple endocrine neoplasia), MEN 2B, neurofibromatosis, or von Hippel-Lindau disease
- History of adrenal disease or tumor
- Hypertension with systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 despite treatment
- Untreated or inadequately treated mental illness
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
- Unable to completely avoid acetaminophen for duration of study
- Established history of allergy or severe reaction to adhesive or tape that must be used in the study
- History of eating disorder within the last 2 years, such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight
- History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
- Lives in or frequents areas with poor Verizon wireless network coverage (which would prevent remote monitoring)
- Any factors that, in the opinion of the site principal investigator or overall principal investigator, would interfere with the safe completion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.
Read the detailed description
A total of 16 subjects, ages 18-45, will be enrolled in this crossover study. The study will consist of three 7-day study arms in the following order, one usual care arm, one bionic pancreas insulin only arm with a static glucose target, and one bionic pancreas insulin only arm with at dynamic glucose target.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Fixed set point, Variable set point
- Keywords
- bionic pancreas, closed-loop control, artificial pancreas
- 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.
Fixed set pointDevice
Fixed set point arm: A fixed setpoint will be used initially. Staff will observe glucose control over 2 days while subjects remain in a hotel environment, and then over 5 more days in the same subjects in an outpatient setting. The clinical staff will adjust this target up or down by 15 mg/dl based on their glycemic control in the hotel setting.
Variable set pointDevice
Variable set point arm: The setpoint will be variable over a 30 mg/dl range and glycemic control will be optimized based on the preceding 24-hour window.
| Study group | Role | What they receive |
|---|---|---|
| Blinded Sensor | No intervention | Subjects will wear a blinded Dexcom G4P (Generation 4 Platinum) AP (Artificial Pancreas) glucose sensor for a week |
| Fixed set point | Experimental | Subjects will be in a hotel and use a fixed set point for glucose control for two days initialized at 130 mg/dl. The setpoint will be adjusted, if necessary, over the two days in the hotel before they are sent home for 5 days Receives: Device: Fixed set point |
| Variable Set Point | Experimental | Subjects will begin using a "variable" setpoint which will make adjustments based on their past glucose control over the previous day Receives: Device: Variable set point |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean glucose
Dexcom G4P AP mean glucose
Measured: change over 5 days
Secondary outcomes (7)
% time <50 mg/dl
Fraction of Dexcom G4P AP readings <60 mg/dl
Measured: change over 5 days
% time <70 mg/dl
Fraction of Dexcom G4P AP readings <70 mg/dl
Measured: change over 5 days
% time 70-120 mg/dl
Fraction of Dexcom G4P AP readings 70-120 mg/dl
Measured: change over 5 days
% time 70-180 mg/dl
Fraction of Dexcom G4P AP readings 70-180 mg/dl
Measured: change over 5 days
% time >180 mg/dl
Fraction of Dexcom G4P AP readings >180 mg/dl
Measured: change over 5 days
% time >250 mg/dl
Fraction of Dexcom G4P AP readings >250 mg/dl
Measured: change over 5 days
% time < 60 mg/dl
Fraction of Dexcom G4AP readings < 60 mg/dl
Measured: Change over 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruce A. Buckingham
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Massachusetts General Hospital
- Responsible party
- Sponsor-investigator, Bruce A. Buckingham, Stanford University
- Investigators
- Bruce A Buckingham, MD, Principal investigator, Stanford School of Medicine, Pediatric Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536950
- Sponsor's protocol ID
- IRB34914
- Status last verified
- Jun 2018
- First submitted
- 18 Jul 2015
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
- ClinicalTrials.gov ID
- NCT02536950
- Acronym / sponsor ID
- IRB34914
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- bionic pancreas, closed-loop control, artificial pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bruce A. BuckinghamUniversity, hospital or other
- Collaborators
- Boston University, Massachusetts General Hospital
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.
Detailed description
A total of 16 subjects, ages 18-45, will be enrolled in this crossover study. The study will consist of three 7-day study arms in the following order, one usual care arm, one bionic pancreas insulin only arm with a static glucose target, and one bionic pancreas insulin only arm with at dynamic glucose target.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blinded Sensor | No intervention | –Subjects will wear a blinded Dexcom G4P (Generation 4 Platinum) AP (Artificial Pancreas) glucose sensor for a week |
| Fixed set point | Experimental | Device: Fixed set pointSubjects will be in a hotel and use a fixed set point for glucose control for two days initialized at 130 mg/dl. The setpoint will be adjusted, if necessary, over the two days in the hotel before they are sent home for 5 days |
| Variable Set Point | Experimental | Device: Variable set pointSubjects will begin using a "variable" setpoint which will make adjustments based on their past glucose control over the previous day |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Type 1 diabetes for at least 1 year
- insulin pump for ≥ 6 months
- Prescription medication regimen stable for > 1 month
- Subject comprehends written English
- Female patients who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD (Intrauterine Device)
Key exclusion criteria (33 listed)
- Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)
- Subject has a history of diagnosed medical eating disorder
- Subject has a history of visual impairment which would not allow subject to participate
- Subject has an active skin condition that would affect sensor placement
- Subject has adhesive allergies
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 |
|---|---|---|
| Fixed set pointFixed set point arm: A fixed setpoint will be used initially. Staff will observe glucose control over 2 days while subjects remain in a hotel environment, and then over 5 more days in the same subjects in an outpatient setting. The clinical staff will adjust this target up or down by 15 mg/dl based on their glycemic control in the hotel setting. | Device | Fixed set point |
| Variable set pointVariable set point arm: The setpoint will be variable over a 30 mg/dl range and glycemic control will be optimized based on the preceding 24-hour window. | Device | Variable Set Point |
Primary outcome
Mean glucose
Time frame: change over 5 days
Dexcom G4P AP mean glucose
7 secondary outcomes
% time <50 mg/dl
Time frame: change over 5 days
% time <70 mg/dl
Time frame: change over 5 days
% time 70-120 mg/dl
Time frame: change over 5 days
% time 70-180 mg/dl
Time frame: change over 5 days
% time >180 mg/dl
Time frame: change over 5 days
% time >250 mg/dl
Time frame: change over 5 days
% time < 60 mg/dl
Time frame: Change over 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Bruce A Buckingham, MD principal investigator
Stanford School of Medicine, Pediatric Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed set point and Variable set point in people with Diabetes Mellitus, Type 1, run by Bruce A. Buckingham 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 10 inclusion and 33 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 21 Jun 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean glucose (time frame: change over 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2018.