Summary:
ICON Early Phase Services is conducting a research study for adults with type 2 diabetes taking insulin, ages 45-70. This study is being done to gather data. The data will be used to create a glycemic model of a type 2 diabetic subject to enable future insulin dosing recommendations. There is no investigational drug.
Vital signs, ECGs, physical examinations, fasting glucose tolerance testing, and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
- 2 screening visits
- 14 consecutive overnights
- 4 outpatient visits
- 2 weeks of at-home dosing
- monitoring of several devices
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am a type 2 diabetic currently taking both a rapid acting insulin (e.g., humalog, novolog, apidra) and a long acting insulin (e.g., Lantus, levemir)
- I am between 45 - 70 years old (on Day 1)
- My A1c level is ≥ 7.7 and ≤ 10 (+/- 0.2)
- I am a non-smoker. I agree not to smoke for the duration of the study and to abide by the rules of the clinic, which is a non-smoking facility.
- I am not currently enrolled in another study and I do not plan to enroll in another clinical trial before the end of this study. And, it has been 7+ days since the conclusion of my last participation in a study to Day 1 of this study (training visit).
- If Female, I am not pregnant or breastfeeding
- If Female and capable of becoming pregnant, I agree to use an acceptable method of contraception throughout the study. Acceptable methods of birth control are:
- hormonal contraception = oral, implantable, or intravaginal
- abstinence
- barrier methods = IUD, male condom + spermicide, diaphragm + spermicide, female condom + spermicide
- I agree not to have an X-ray, MRI or CT scan during study participation
- I am able to communicate effectively in English with the study personnel
- I have, and can navigate, either an iPhone or an Android phone. (NOTE: One group will use either Android or iPhones and one group will use an iPhone.)
- I am comfortable entering study data daily into various apps and I am able to download apps to my smartphone/laptop, sync/upload data into apps, download/transfer data to a cloud environment and I have sufficient data cellular roaming to run all devices on my phone 24/7 for 4 weeks
- I am able to have my phone with me and operable at all times
- I have and can navigate a computer for data upload. (NOTE: This will depend upon the group you are in.)
- I am able to wear a glucose meter, glucose monitor, or an insulin pump
- I have the dexterity to insert a continuous glucose monitor and vision that allows me to log data into a phone app
- I am able to tolerate metformin
- I am able to wear an activity tracker
- I do not have severe gastroparesis (weakness of the muscles in the stomach)
- I do not have hypoglycemia unawareness
- I do not have extensive skin changes/diseases at sensor wear or pump site(s) that preclude wearing the sensor and/or pump (e.g., psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, skin lesions, redness, infection or edema) (NOTE: Wear area sites - such as the wrist, arm or abdomen)
- I am able to consume prepared meals and standardized packaged meals as required by the study
- I am able to refrain from using acetaminophen during specific periods of time
- I do not have a history of any severe or life-threatening allergies (e.g., medical trade adhesive, food, drugs or latex)
- I do not have an allergy to medical-grade adhesive
- I tolerate oral medication well
- I have not had problems having blood drawn in either arm, venous access or finger pricks.
Qualified Participants May Receive:
Qualified participants may be compensated up to $6,230 for time and travel.