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The Set-Point Study: Evaluating Effects of Changing Glucose Target on Bionic Pancreas Performance

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes

Intervention: Bionic Pancreas (Device); Usual Care (Other)

Phase: Phase 2/Phase 3

Status: Not yet recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Steven J Russell, MD, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Courtney A Balliro, BS, RN, CDE, Phone: 617-726-1242, Email: cballiro@partners.org


The current study is designed to determine the effect on mean glucose, hypoglycemia, glucagon usage, and insulin usage of adjusting upward the glucose target of the bi-hormonal bionic pancreas, and determine whether there is a target at which adequate glycemic control is achieved by an insulin-only bionic pancreas with minimal hypoglycemia.

Clinical Details

Official title: The Set-Point Study: Evaluating Effects of Changing Glucose Target on Bionic Pancreas Performance

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Primary Purpose: Treatment

Primary outcome:

Mean CGM glucose values

Fraction of time with CGM < 60 mg/dl

Number of subjects discordant for reaching a BG < 60 mg/dl for > 2 consecutive plasma glucose measurements during inpatient exercise visit

Secondary outcome:

Mean CGM glucose

Fraction of time spent in: < 50 mg/dl, < 60 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl

Correlation between the bionic pancreas target and the mean CGM glucose

Correlation between the bionic pancreas target and time < 60 mg/dl

Percentage of subjects with mean CGM < 154 mg/dl

Number of hypoglycemic events (< 70 mg/dl, <60 mg/dl, <50 mg/dl)

Area between the glucose curve and 60 mg/dl calculated from BG measurements

Area between the glucose curve and 60 mg/dl calculated from CGM measurements

Time from start of exercise to first BG measurement < 60 mg/dl

Time from start of exercise to first CGM measurement < 60 mg/dl

Fraction of days that CGM was used by participants as part of their usual care

Number of severe hypoglycemic events

Glucagon total daily dose in bi-hormonal bionic pancreas arm

Insulin total daily dose

Correlation between bionic pancreas target and mean insulin dosing by the bionic pancreas

Correlation between bionic pancreas target and mean glucagon dosing by the bionic pancreas

Number of episodes of symptomatic hypoglycemia (reported daily by subjects)

Number of reported carbohydrate interventions for hypoglycemia (reported daily by subjects)

Total grams of carbohydrate taken for hypoglycemia

Fraction of time bionic pancreas off-line or not functioning properly

Grams of oral carbohydrates given to the subject to treat hypoglycemia

Total glucagon dosing by bi-hormonal bionic pancreas from the start of exercise until the end of the visit

Episodes of nausea and nausea index

Change in body weight

Any skin rash, either local to infusion sites or more generalized with subject reported severity and timing


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Age ≥ 18 years and have had clinical type 1 diabetes for at least one year

- Diabetes managed using an insulin pump for ≥ 6 months

- Prescription medication regimen stable for > 1 month (except for medications that

will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgment of the principal investigator)

- Live within a 60 minute drive-time radius of the central monitoring location

- Willing to remain within a 120 minute drive-time radius of the central monitoring

location throughout the study

- Have someone over 18 years of age who lives with them, has access to where they

sleep, is willing to be in the house when the subject is sleeping, and is willing to receive calls from the study staff and check the welfare of the study subject if telemetry shows a technical problem or severe biochemical hypoglycemia without subject response and the subject does not answer their telephone (up to two individuals can share this role, but they must be willing to carefully coordinate with each other and the subject so that one of them is clearly designated as having this responsibility at any given time)

- Willing to wear two infusion sets and one CGM sensor and change sets frequently (at

least one new glucagon infusion set daily during bi-hormonal arms, and insulin infusion set every other day throughout the study) Exclusion Criteria:

- Unable to provide informed consent (e. g. impaired cognition or judgment)

- Unable to safely comply with study procedures and reporting requirements (e. g.

impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory, unable to speak and read English)

- Current participation in another diabetes-related clinical trial that, in the

judgment of the principal investigator, will compromise the results of this study or the safety of the subject

- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the

immediate future, or sexually active without use of contraception

- Need to go outside of the designated geographic boundaries during the study

- 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)

- 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

- Unwilling or unable or to avoid use of drugs that may dull the sensorium, reduce

sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study (use of beta blockers will be allowed as long as the dose is stable and the subject does not meet the criteria for hypoglycemia unawareness while taking that stable dose, but use of benzodiazepines or narcotics, even if by prescription, may be excluded according to the judgment of the principal investigator)

- History of liver disease that is expected to interfere with the anti-hypoglycemia

action of glucagon (e. g. liver failure or cirrhosis). Other liver disease (i. e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion.

- 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 including, but not limited to, history

of myocardial infarction, stress test showing ischemia, history of angina, or history of intervention such as coronary artery bypass grafting, percutaneous coronary intervention, or enzymatic lysis of a presumed coronary occlusion)

- Abnormal EKG consistent with coronary artery disease or increased risk of malignant

arrhythmia including, but not limited to, evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), prolonged QT interval (> 440 ms). Non-specific ST segment and T wave changes are not grounds for exclusion in the absence of symptoms or history of heart disease. A reassuring evaluation by a cardiologist after an abnormal EKG finding may allow participation.

- Congestive heart failure (established history of CHF, lower extremity edema,

paroxysmal nocturnal dyspnea, or orthopnea)

- History of 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: fractionated metanephrines will be tested in patients

with history increasing the risk for a catecholamine secreting tumor: oEpisodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension oParoxysms of tachycardia, pallor, or headache oPersonal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease

- History of adrenal disease or tumor

- Hypertension with systolic BP ≥160 mm Hg or diastolic BP ≥100 despite treatment

- Untreated or inadequately treated mental illness (indicators would include symptoms

such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with anti-psychotic medications that are known to affect glucose regulation.

- Electrically powered implants (e. g. cochlear implants, neurostimulators) that might

be susceptible to RF interference

- Unable to completely avoid acetaminophen for duration of study

- History of adverse reaction to glucagon (including allergy) besides nausea and


- 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

- Use of oral (e. g. thiazolidinediones, biguanides, sulfonylureas, glitinides, DPP-4

inhibitors, SGLT-2 inhibitors) anti-diabetic medications

- Lives in or frequents areas with poor Verizon wireless network coverage (which would

prevent remote monitoring)

- Any factors that, in the opinion of the principal investigator would interfere with

the safe completion of the study

Locations and Contacts

Courtney A Balliro, BS, RN, CDE, Phone: 617-726-1242, Email: cballiro@partners.org

Masscahusetts General Hospital, Boston, Massachusetts 02114, United States; Not yet recruiting
Courtney A Balliro, BS, RN, CDE, Phone: 617-726-1242, Email: cballiro@partners.org
Steven J Russell, MD, PhD, Principal Investigator
Edward Damiano, PhD, Sub-Investigator
Firas El-Khatib, PhD, Sub-Investigator
Manasi Sinha, MD, MPh, Sub-Investigator
Laya Ekhlaspour, MD, Sub-Investigator
Additional Information

Starting date: August 2015
Last updated: July 24, 2015

Page last updated: August 23, 2015

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