Study Details

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An Automated Insulin Delivery System Study for Type 2 Diabetes

Many patients with type 2 diabetes do not achieve their goals for managing their blood sugar and are therefore at risk for developing complications, despite treatment with insulin and other medications for diabetes. Automated insulin delivery systems have been shown to be beneficial for patients with type 1 diabetes, and may be equally beneficial for patients with type 2 diabetes.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will be asked to wear a CGM (continuous glucose monitor) and an insulin pump. You will be asked to replace the CGM and insulin pump infusion sets on your own at home. You will be asked to confirm blood sugar alerts with a fingerstick. At study visits, you will meet with a member of the study team to get vital signs and answer questions about your health and your experience with the twiist system. This study also involves blood draws, urine pregnancy testing (if applicable) and an EKG if you have not had one within a year of joining the study.

Incentives

Information provided upon request, insulin pump supplies and Freestyle Libre 3 Plus CGM

In-person visits:
3-8

Phone or online visits:
5-9

Total length of participation:
4 months

Looking for Specific Volunteers

Able to participate:

you have had type 2 diabetes for at least 6 months
you use an insulin pump without automation or are taking insulin injection(s) every day
you are willing to use only approved insulin for use in the twiist pump (Novolog or Humalog U-100)

Not eligible if:

you have type 1 diabetes or do not have diabetes
you are currently using an automated insulin delivery system
you are currently taking part in another diabetes treatment study
you are pregnant, breastfeeding, planning to become pregnant in the next 4 months, or are unwilling to use adequate contraception
you do not have reliable telephone or internet service for contact from the study team

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Clinical Research Unit
UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Jamie Diner
Medicine-Endocrinology

Study Type

Clinical or Medical
Interventional

Study Topics

Diabetes

IRB Number

25-0060

ClinicalTrials.gov

NCT06853990