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:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT00982293
Eligibility Criteria:
Inclusion Criteria:
* Current diagnosis of Type 2 Diabetes Mellitus with a hemoglobin A1c level above 7.5%, despite management of diabetes with diet and/or medication.
* Subject currently performs routine finger stick blood sugar testing as part of his or her current diabetes disease management regimen.
* Subject is ambulatory
* Subject is on stable oral medication regimen without significant side effects for at least three (3) months (stable insulin regimen NOT permissible); willingness and ability to maintain the stable oral medication regimen throughout the course of the study. If on agents suspected of contributing to hyperglycemia(see list below), subject must have been on a stable dose of this(these) agent(s) for 6 months prior to study initiation.
* Hemoglobin A1c levels within a 0.8 % range of patient mean A1c level for the last two documented determinations, that must be within 2 years of the baseline testing date.
* Willingness to test finger stick blood sugars according to prescribed protocol.
* Willingness to have lab test blood draws performed according to prescribed protocol
* Willingness to maintain stable diet and activity regimen for the duration of the study.
* Willing and able to abstain from partaking in any non-essential (not physician ordered) existing or new treatments to improve serum blood sugar levels
* Willing and able to abstain from all medications that could affect diabetes mellitus and/or any of its associated symptoms for the duration of the study
* Adequate contraceptive measures for females subjects
* Any ethnic background
Exclusion Criteria:
* Change in medical regimen within 3 months prior to initiation of study.
* Any signs of type 1 diabetes mellitus (including any history of ketoacidosis or new requirement for insulin therapy within the 6 month period prior to study initiation).
* Active significant infectious process within 3 weeks of study initiation causing wide fluctuations in finger stick blood sugar level
* Change in BMI of greater than 6 % within a 3 month period prior to study initiation
* Any planned revascularization procedure.
* Symptomatic congestive heart failure.
* Leg or foot ulceration or open wounds
* Gangrene.
* History of intermittent claudication
* Hemodialysis
* Currently being treated for malignancy
* Currently being treated with oral or intravenous catabolic steroids
* Reported consumption of more than 14 alcoholic drinks per week.
* Pregnant, breast feeding, or planning pregnancy prior to the end of participation
* Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements
* Uncontrolled hypertension
* Uncontrolled atrial fibrillation or other uncontrolled arrythmias, e.g. tachycardia, bradycardia
* Uncontrolled seizure disorder
* Uncontrolled, unstable, or untreated medical conditions which may significantly impact the subject's health or ability to complete the entire study, in the opinion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT00982293
Study Brief:
Protocol Section:
NCT00982293