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

Completed · Phase 4

Conditions studied: Type 1 Diabetes Mellitus

In brief

A multi-center, randomized, crossover trial consisting of three sequential 12-week periods, with the HCL feature used during one period, the PLGS feature used during one period and SAP therapy (control) during one period. The crossover trial will be preceded by a run-in phase in which participants will receive training using the study devices (Dexcom G6 and Tandem t:slim X2 pump). After the last crossover period, participants will be given the opportunity to use study devices for an additional 12 weeks to assess preference of system use (PLGS, HCL or SAP) and associated characteristics, durability and safety in a more real-world setting with less frequent study contact.

Key facts

Study ID

NCT04016662

Run by

Jaeb Center for Health Research

People needed

82

Starts

2020-09-28

Expected to finish

2024-01-05

Last updated by the study team

2025-01-15

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Clinical diagnosis of type 1 diabetes
• Age ≥ 65 years old
• T1D Duration of at least 1 year
• HbA1c < 10.0% from point of care or local lab within the past 6 months
• Insulin regimen involves basal/bolus insulin via insulin pump or multiple daily injections
• Most recent GFR ≥ 30 ml/min/m\^2 from local lab within the past 6 months
• 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)
• Familiarity with and willingness to use a carbohydrate ratio for meal boluses
• Willing to use study devices and automated insulin delivery features
• 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
• Participant is independently managing his/her diabetes with respect to insulin administration and glucose monitoring (may include assistance from spouse or other caregiver)
• 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
• Participant comprehends written and spoken English
• At least 240 hours of CGM readings available during the end of run-in assessment
• At least 1.5% of time with CGM glucose levels < 70 mg/dL prior to SAP initiation
• Active prescription for glucagon and willing and able to have glucagon available

You may not qualify if…

• Use of PLGS technology or HCL insulin delivery in the past 1 month
• History of 1 or more Diabetic Ketoacidosis episodes in the previous 6 months
• 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)
• 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
• 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
• Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
• Stage 4 or 5 renal disease
• 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

Where it is running

• AdventHealth Diabetes Institute — Orlando, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States
• SUNY Upstate — Syracuse, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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