Status:
COMPLETED
Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
DexCom, Inc.
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
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 (contro...
Detailed Description
Automated insulin delivery (AID) technologies hold the promise of optimizing glycemic control and reducing the burden of diabetes care for patients with Type 1 Diabetes (T1D). However, clinical trials...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2024
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04016662
Start Date
September 28 2020
End Date
January 5 2024
Last Update
January 15 2025
Active Locations (4)
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1
AdventHealth Diabetes Institute
Orlando, Florida, United States, 32803
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
SUNY Upstate
Syracuse, New York, United States, 13214
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104