| Eligibility |
Inclusion Criteria:
1. =21 and <65 years old.
2. Clinical diagnosis of type 1 diabetes mellitus. For an individual to be enrolled at
least one criterion from each list must be met.
o Criteria for documented hyperglycemia (at least 1 must be met): i. Fasting glucose
=126 mg/dL - confirmed ii. Two-hour Oral Glucose Tolerance Test glucose =200 mg/dL -
confirmed iii. Hemoglobin A1C (HbA1c) =6.5% documented - confirmed iv. Random glucose
=200 mg/dL with symptoms v. No data at diagnosis is available but the participant has
a convincing history of hyperglycemia consistent with diabetes
o Criteria for requiring insulin at diagnosis (1 must be met): i. Participant required
insulin at diagnosis and continually thereafter ii. Participant did not start insulin
at diagnosis but upon investigator review likely needed insulin (significant
hyperglycemia that did not respond to oral agents) and did require insulin eventually
and used continually iii. Participant did not start insulin at diagnosis but continued
to be hyperglycemic, had positive islet cell antibodies - consistent with latent
autoimmune diabetes in adults (LADA) and did require insulin eventually and used
continually
3. Use of an insulin pump to treat his/her diabetes for at least 1 year.
4. Familiarity with a bolus calculator with the current insulin pump with pre-defined
parameters for carbohydrate ratio, insulin sensitivity factor (ISF), target glucose
and active insulin.
5. HbA1c <9% as measured with DCA2000 or equivalent device.
6. Not currently known to be pregnant, breast feeding, or intending to become pregnant
(females).
7. Demonstration of proper mental status and cognition for the study.
8. Willingness to avoid consumption of acetaminophen-containing products 24 hours prior
to and during CGM use.
9. Ability to access the Internet and upload CGM data via the company software during the
data collection period.
10. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have
stability on the medication for at least 2 months prior to enrollment in the study.
Exclusion Criteria
1. Severe hypoglycemia resulting in seizure, loss of consciousness, or diabetic
ketoacidosis within the 12 months prior to enrollment.
2. Pregnancy; breast feeding, or intention of becoming pregnant.
3. Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or
systolic blood pressure >160 mmHg).
4. Conditions which may increase the risks associated with possible hypoglycemia, such as
any active cardiac disorder/arrhythmia, uncontrolled coronary artery disease during
the previous year (e.g. history of myocardial infarction, acute coronary syndrome,
therapeutic coronary intervention, coronary bypass or stenting procedure, stable or
unstable angina, episode of chest pain of cardiac etiology with documented EKG
changes, or positive stress test or catheterization with coronary blockages >50%),
congestive heart failure, history of cerebrovascular event, seizure disorder, syncope,
uncontrolled adrenal insufficiency, neurologic disease or atrial fibrillation.
5. Self-reported hypoglycemia unawareness.
6. History of a systemic or deep tissue infection with methicillin-resistant staph aureus
or Candida albicans.
7. Use of a device that may pose electromagnetic compatibility issues and/or
radiofrequency interference with the Continuous Glucose Monitor (CGM) (implantable
cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump,
and cochlear implants).
8. Anticoagulant therapy other than aspirin.
9. Oral steroids.
10. Subjects currently taking Amylin.
11. Medical condition requiring use of an acetaminophen-containing medication that cannot
be withheld for the study sessions.
12. Psychiatric disorders that would interfere with study tasks (e.g. inpatient
psychiatric treatment within 6 months prior to enrollment).
13. Mental incapacity, unwillingness or language barriers precluding adequate
understanding or cooperation.
14. Known current or recent alcohol or drug abuse.
15. Medical conditions that would make operating a CGM, the Diabetes Assistant (DiAs) cell
phone or insulin pump difficult (e.g. blindness, severe arthritis, immobility).
16. Any skin condition that prevents sensor or pump placement on the abdomen or arm (e.g.
bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, and
cellulitis).
17. In adherence with the One Touch Ultra 2 User Guide that may be used in the
experimental session and overnight during substudy, subjects with hematocrit levels
less than 30% and above 55% will be excluded.
18. Impaired hepatic function measured as alanine aminotransferase or aspartate
aminotransferase
=three times the upper reference limit.
19. Impaired renal function measured as creatinine >1.2 times above the upper limit of
normal.
20. Uncontrolled microvascular (diabetic) complications, such as current proliferative
diabetic retinopathy or macular edema, known diabetic nephropathy (other than
microalbuminuria with normal creatinine) or neuropathy requiring treatment.
21. Active gastroparesis requiring current medical therapy.
22. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of
stability on the medication for the past 2 months prior to enrollment in the study.
23. Uncontrolled thyroid disease.
24. Known bleeding diathesis or dyscrasia.
25. Known allergy to medical adhesives, components of the insulin pump insertion set or
continuous glucose monitor sensor.
26. Active enrollment in another treatment clinical trial. Observational trials may be
permitted at the discretion of the study physician.
27. Use of anti-diabetic agents other than continuous subcutaneous insulin infusion (CSII)
including long-acting insulin, intermediate-acting insulin, metformin, sulfonylureas,
meglitinides, thiazolidinediones, Dipeptidyl peptidase-4 inhibitors, glucagon- like
peptide 1 agonists, and alpha-glucosidase inhibitors
28. Unwillingness to use an approved form of birth control during this study by a sexually
active female participant.
29. Subjects with basal rates less than 0.01U/hr.
RESTRICTIONS ON USE OF OTHER DRUGS OR TREATMENTS
1. Use of anti-diabetic agents other than CSII including long-acting insulin,
intermediate-acting insulin, metformin, sulfonylureas, meglitinides,
thiazolidinediones, Dipeptidyl peptidase-4 inhibitors, glucagon- like peptide 1
agonists, and alpha-glucosidase inhibitors.
2. Acetaminophen will be restricted starting 24 hours prior to CGM use.
3. Medications that block symptoms of hypoglycemia, including but not limited to beta
blockers.
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