The Monitoring Study
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/1/2018 |
Start Date: | April 1, 2017 |
End Date: | December 28, 2017 |
The Monitoring Study: Evaluating the Effect of Remote Monitoring For Hypoglycemia on Bionic Pancreas Safety and Efficacy
To conduct an outpatient study testing two configurations of the bionic pancreas (bi-hormonal
and insulin-only) with and without remote monitoring of hypoglycemia in 25 adult (≥ 18 years
of age) subjects with type 1 diabetes in a random-order crossover study versus usual care
with an insulin pump with and without remote monitoring of hypoglycemia.
and insulin-only) with and without remote monitoring of hypoglycemia in 25 adult (≥ 18 years
of age) subjects with type 1 diabetes in a random-order crossover study versus usual care
with an insulin pump with and without remote monitoring of hypoglycemia.
The rationale for this study is to measure the safety of eliminating the glycemic monitoring
that the investigators have done in all of the previous outpatient studies under both insulin
only and bihormonal bionic pancreas control. The investigators are planning to transition the
outpatient studies to an integrated bionic pancreas, the iLet, in the near future. The
intended use of this device does not include remote monitoring, which would not be feasible
on a commercial scale. Therefore, in this trial the investigators will test the effects on
hypoglycemia of eliminating blood glucose related monitoring. In addition, the investigators
will perform a pilot trial testing the effects of the bionic pancreas on food intake,
exercise, weight and body composition. The primary purpose of this pilot is to assess the
feasibility of performing these measurements in the context of a larger trial and to collect
data that can be used to power sub-studies of pivotal trials looking at these outcomes.
Finally, the investigators will test the accuracy of two new CGM devices to see if they have
sufficient accuracy to provide glucose data to the bionic pancreas. If so, this would provide
new options for users who may have difficulties with the only currently validated CGM for
this purpose, the Dexcom G4 AP / G5 platform.
that the investigators have done in all of the previous outpatient studies under both insulin
only and bihormonal bionic pancreas control. The investigators are planning to transition the
outpatient studies to an integrated bionic pancreas, the iLet, in the near future. The
intended use of this device does not include remote monitoring, which would not be feasible
on a commercial scale. Therefore, in this trial the investigators will test the effects on
hypoglycemia of eliminating blood glucose related monitoring. In addition, the investigators
will perform a pilot trial testing the effects of the bionic pancreas on food intake,
exercise, weight and body composition. The primary purpose of this pilot is to assess the
feasibility of performing these measurements in the context of a larger trial and to collect
data that can be used to power sub-studies of pivotal trials looking at these outcomes.
Finally, the investigators will test the accuracy of two new CGM devices to see if they have
sufficient accuracy to provide glucose data to the bionic pancreas. If so, this would provide
new options for users who may have difficulties with the only currently validated CGM for
this purpose, the Dexcom G4 AP / G5 platform.
Inclusion Criteria:
- Age ≥ 18 years and have had clinical type 1 diabetes for at least one year 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 one or two infusion sets and one Dexcom 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)
- Willing to wear two additional CGM sensors that must be placed in the upper arm
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 Subjects must use
acceptable contraception for the two weeks prior to the study, throughout the study
and for the two weeks following the study.
Acceptable contraception methods include: Oral contraceptive pill (OCP), Intrauterine
Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap
with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as
Implanon, Nexplanon), Vaginal ring (such as NuvaRing), Progestin shot (such as
Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis
- 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
- 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:
- 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, 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
- The presence of any other active implanted device
- Unable to completely avoid acetaminophen for duration of study
- Unable to completely avoid ascorbic acid (Vitamin C) for duration of study
- Unable to completely avoid salicylic acid (used in some pain relievers such as Aspirin
and some skin care products)
- History of adverse reaction to glucagon (including allergy) besides nausea and
vomiting
- 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
- A condition preventing or complicating the placement, operation or removal of the
Senseonics sensor or wearing of transmitter, including upper extremity deformities or
skin condition
- Currently receiving (or likely to need during the study period): immunosuppressant
therapy, chemotherapy, anticoagulant/antithrombotic therapy (excluding aspirin),
glucocorticoids (excluding ophthalmic or nasal). This does include the use of inhaled
and topical glucocorticoids and antibiotics for chronic infection
- A condition requiring or likely requiring magnetic resonance imaging (MRI), Computed
Tomography (CT) scan, or high-frequency electrical heat (diathermy)
- A known topical or local anesthetic allergy
- A known glucocorticoids allergy
- The presence of any other CGM sensor or transmitter located in the upper arm (other
location is acceptable)
- Hemoglobin < 12 g/dl
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