Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT01472406
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months with commercially available rapid actin insulin
* The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
* Age 21 to 65 years
* For females, not currently known to be pregnant or nursing
* HbA1c between 5.0% and 10%, as measured with DCA2000 or equivalent device
* Willing to perform the calibration of the study CGMs using a finger stick only and willing to follow instructions for insulin pump and CGM wear.
* Willing to use the study CGM and study insulin pump during closed-loop.
* Able to and agrees to avoid the following medication starting 24 hours before sensor wear through completion of CRC visit: acetaminophen, prednisone, and pseudoephedrine.
* An understanding of and willingness to follow the protocol and sign the informed consent
Exclusion Criteria:
* Pregnancy (as determined by a positive blood pregnancy test performed in females of childbearing capacity during screening visit and urine test at time of admission for in-patient visit) or nursing mother.
* Diabetic ketoacidosis in the past 6 months prior to enrollment requiring emergency room visit or hospitalization
* Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
* Current treatment for a seizure disorder; Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist
* Cystic fibrosis
* Active infection
* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as cognitive deficit.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write.
* Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
* Coronary artery disease or heart failure. Subjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist
* Presence of a known adrenal disorder
* Active coronary artery disease or heart failure
* Active gastroparesis
* 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
* Uncontrolled thyroid disease. Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
* Abuse of alcohol
* A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
* Current use of a beta blocker medication
* Laboratory results:
* Hematocrit \< 30% or \>55%
* A1C \> 10%
* Abnormal liver or renal function (Transaminase \> 2 times the upper limit of normal, Creatinine\> 1.5 mg/dL)
* Labs drawn at screening visit or within one month prior to screening (for other purposes) will suffice for enrollment purposes related to hematocrit
* Subject has skin conditions that, in the determination of the investigator, would preclude wearing the study devices (infusion set and sensor), in the abdomen. Examples include but are not limited to: psoriasis, burns, scaring, eczema, tattoos, and significant hypertrophy at sites of device wear; any known allergy to medical adhesives.
* Current participation in another investigational trial or has previously participated to this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01472406
Study Brief:
Protocol Section:
NCT01472406