Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D) (AIDE T1D)

This is an interventional treatment trial for Type 1 Diabetes Mellitus Read More

Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes
2. Age ≥ 65 years old
3. T1D Duration of at least 1 year
4. HbA1c < 10.0% from point of care or local lab within the past 6 months
5. Insulin regimen involves basal/bolus insulin via insulin pump or multiple daily injections
6. Most recent GFR ≥ 30 ml/min/m^2 from local lab within the past 6 months
7. Willingness to use a rapid acting insulin compatible with the Tandem t:slim X2 pump (currently aspart and lispro; other rapid acting insulins likely to be approved for pump use prior to study initiation such as Fiasp)
8. Familiarity with and willingness to use a carbohydrate ratio for meal boluses
9. Willing to use study devices and automated insulin delivery features
10. Ability to download study devices at home or if not able to download at home willing to come into clinic to bring devices for download of data at visits and as needed for safety
11. Participant is independently managing his/her diabetes with respect to insulin administration and glucose monitoring (may include assistance from spouse or other caregiver)
12. Participant understands the study protocol, agrees to comply with it and is able to successfully pass the consent understanding assessment with no more than 2 attempts
13. Participant comprehends written and spoken English
14. At least 240 hours of CGM readings available during the end of run-in assessment
15. At least 1.5% of time with CGM glucose levels < 70 mg/dL prior to SAP initiation
16. Active prescription for glucagon and willing and able to have glucagon available

Exclusion Criteria:

1. Use of PLGS technology or HCL insulin delivery in the past 1 month
2. History of 1 or more Diabetic Ketoacidosis episodes in the previous 6 months
3. Clinical diagnosis by a primary care provider, neurologist or psychiatrist of dementia, in the investigator's opinion a suspected severe cognitive impairment such that it would preclude ability to understand the study or use devices, or a score of 6 or less out of 15 on the 5 min MoCA (5-min T MoCA Version 2.1) (mild cognitive impairment is not an exclusion)
4. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk, including severe vision or hearing impairment and any contraindication to the use of any of the study devices per FDA labeling
5. Known adhesive allergy or skin reaction during the run-in pre-randomization phase or previous difficulty with pump and CGM insertions that would preclude participation in the randomized trial
6. Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
7. Stage 4 or 5 renal disease
8. The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of <1 year