Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes

Summary

The purpose of this clinical trial is to test the safety and feasibility of using an Automated Insulin Device (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration. Participants will be randomized to either the control group or the experimental group. If in the experimental group, the participant will use an insulin pump with Control-IQ Technology (Tandem Diabetes Care) for ten days. Researchers will compare the glycemic control of the experimental group to the control group.

Eligibility

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 two months (e.g., insulin glargine, insulin degludec)
5. If using a CGM, willingness to wear an additional study 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 who self-report that they are 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 to remain on same dose of non-insulin glucose-lowering agent during the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals).

Exclusion Criteria:

1. Currently using an approved intermediate (e.g., insulin NPH) or rapid insulin for at least six months (e.g., insulin aspart, insulin lispro, insulin regular).
2. Currently being treated for a seizure disorder.
3. 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:

   1. Inpatient psychiatric treatment in the past 6 months
   2. Presence of a known adrenal disorder
   3. Uncontrolled thyroid disease
4. Currently pregnant or intent to become pregnant during the trial.
5. Currently breastfeeding.
6. Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.
7. History of hypoglycemia unawareness.
8. On a non-stable dose of non-insulin glucose-lowering agent prior to the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals) as defined by study physician.

Conditions1

Locations2 sites