Automated Insulin Delivery for Managing Type 2 Diabetes
Short Use of Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study
This study is testing if an automated insulin delivery system can help people with Type 2 Diabetes manage their blood sugar better than standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06024928 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and feasibility of using an Automated Insulin Device (AID) for basal insulin titration in individuals with Type 2 Diabetes. Participants will be randomly assigned to either a control group or an experimental group, where the latter will use a Tandem t:slim Insulin Pump with Control-IQ Technology for ten days. The study will involve a 10-day run-in phase with a blinded Continuous Glucose Monitor (CGM) followed by a maintenance phase. Researchers will compare glycemic control between the two groups to assess the effectiveness of the AID system.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of Type 2 Diabetes for at least one year and an HbA1c of 7.5% or higher.
Not a fit: Patients who are not currently using long-acting insulin or those who are not willing to discontinue their personal CGM during the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could lead to improved insulin management and better glycemic control for patients with Type 2 Diabetes.
How similar studies have performed: Previous studies have shown promise in using automated insulin delivery systems for diabetes management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18.0 years old at time of consent. 2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year. 3. HbA1c ≥ 7.5%. 4. Currently using an approved long-acting insulin for at least six months (e.g., insulin glargine, insulin degludec) 5. Willingness to discontinue a personal CGM during the duration of the study. 6. Access to the internet and willingness to upload data during the study as needed. 7. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. 8. Willingness not to start any new non-insulin glucose-lowering agent during the trial (including metformin/biguanides, Glucagon-like peptide (GLP)-1 receptor agonists, pramlintide, Dipeptidyl peptidase (DPP)-4 inhibitors, sulfonylureas and nutraceuticals). Exclusion Criteria: 1. Treatment with meglitinides/sulfonylureas. 2. Currently using an approved intermediate (e.g., insulin Neutral Protamine Hagedorn (NPH)) or rapid insulin for at least six months (e.g., insulin aspart, insulin lispro, insulin regular). 3. Currently being treated for a seizure disorder. 4. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples: a) Inpatient psychiatric treatment in the past 6 months, b) Presence of a known adrenal disorder, c) Uncontrolled thyroid disease. 5. Currently pregnant or intent to become pregnant during the trial. 6. Currently breastfeeding. 7. Anticipated surgical, interventional procedures or prolonged periods of fasting during this study. 8. History of hypoglycemia unawareness.
Where this trial is running
Charlottesville, Virginia
- University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Anas El Fathi, PhD — University of Virginia Center for Diabetes Technology
- Study coordinator: Lianna Smith
- Email: lhs7px@uvahealth.org
- Phone: 434-243-6681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.