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

Type 1 Diabetes Mellitus Clinical Trial

— AIDE T1D  

Official title:

A Randomized Cross-over Trial Evaluating Automated Insulin Delivery Technologies on Hypoglycemia and Quality of Life in Elderly Adults With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016662
• Other study ID #: AIDE T1D
• Status: Completed
• Phase: Phase 4
• Start date: September 28, 2020
• Est. completion date: January 5, 2024

Study information

• Verified date: February 2024
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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.

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 of lower burden AID technologies have not included older adults in sufficient numbers to allow for focused evaluation of efficacy and quality of life (QOL) impacts that may differ from those observed in younger age groups. Most notably, primary endpoints have focused on reducing hyperglycemia, while avoidance of hypoglycemia is of upmost concern for older adults with T1D. T1D Exchange clinic registry data have shown severe hypoglycemia (SH) occurs more commonly in older adults with longstanding T1D than in younger individuals with events occurring just as often with HbA1c levels >8.0% as with HbA1c levels <7.0%. These data do not support the strategy of "raising the HbA1c" as being an effective approach for hypoglycemia prevention in older adults with T1D. In addition to acutely altered mental status, hypoglycemia is associated with an increased risk for falls leading to fractures, car accidents, emergency room (ER) visits, hospitalizations, and mortality resulting in substantial societal costs. The occurrence of hypoglycemia, hypoglycemia unawareness and fear of hypoglycemia have adverse effects on overall QOL of both individuals with T1D and their families.

While continuous glucose monitoring (CGM) technology alone has the potential to be beneficial in reducing hypoglycemia in older patients, our preliminary data from the Wireless Innovations for Seniors with Diabetes Mellitus (WISDM) trial shows a majority of patients still have frequent hypoglycemia even when using CGM. Thus, knowledge of CGM alone may not be sufficient to avoid hypoglycemia in this population. Predictive low-glucose suspend algorithms have particular promise when the primary goal is hypoglycemia avoidance rather than glucose reduction. Whether the added complexity of closed loop systems provides additional glycemic benefit is not known. There is a critical need to determine whether automated insulin delivery can reduce hypoglycemia in the older adult population with T1D.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 5, 2024
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Tandom t:slim X2 with HCL or PLGS
The system components include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6. The modular control algorithm has a safety supervision module that limits insulin delivery to prevent hypoglycemia at all times. The algorithm gradually decreases hyperglycemia from bedtime to reach a target of 120 mg/dL by waking time. During awake hours, the control algorithm attempts to maintain glucose within a target range (112.5 to 160 mg/dL) with meal time insulin boluses delivered based on usual bolus procedures undertaken by patients on an insulin pump (Hybrid closed loop). The system components include the t:slim X2 with with Basal-IQ Technology and the Dexcom CGM G6. The PLGS System is able to stop and resume basal insulin delivery automatically in response to predicted or low sensor glucose values, thereby reducing the incidence and duration of hypoglycemic episodes. The pump includes the hypoglycemia minimization strategy that will issue insulin delivery commands.

Locations

Country	Name	City	State
United States	AdventHealth Diabetes Institute	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	SUNY Upstate	Syracuse	New York

Sponsors (9)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	AdventHealth Diabetes Institute, DexCom, Inc., Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc., University of Minnesota - Advanced Research and Diagnostic Laboratory, University of Pennsylvania, Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Reported Questionnaires	Hypoglycemia Fear Survey	12 weeks for each arm of the crossover
Other	Patient Reported Questionnaires	Hypoglycemia Confidence	12 weeks for each arm of the crossover
Other	Patient Reported Questionnaires	Diabetes Distress Scale. 6-point scale from not a problem to a very serious problem. A high total DD score may indicate overall severity.	12 weeks for each arm of the crossover
Other	Patient Reported Questionnaires	AIDE Technology Acceptance is based on the Technology Acceptance Model. 5-point scale from strongly disagree to strongly agree. A high score may indicate acceptance of technology.	12 weeks for each arm of the crossover
Other	Patient Reported Questionnaires	System Usability. 5-point scale from strongly disagree to strongly agree. A high score may indicate ease of system usability.	12 weeks for each arm of the crossover
Primary	CGM Measured Time <70 mg/dL	Percentage of sensor glucose values <70 mg/dL	12 weeks for each arm of the crossover
Secondary	Hypoglycemia	Percentage of sensor glucose values <54 mg/dL	12 weeks for each arm of the crossover
Secondary	Hypoglycemia	Frequency of CGM-measured hypoglycemic events	12 weeks for each arm of the crossover
Secondary	Glucose Control	Mean glucose	12 weeks for each arm of the crossover
Secondary	Glucose Control	Percentage of sensor glucose values 70 to 180 mg/dL	12 weeks for each arm of the crossover
Secondary	Glucose Control	Coefficient of variation	12 weeks for each arm of the crossover
Secondary	Hyperglycemia	Percentage of values >180 mg/dL	12 weeks for each arm of the crossover
Secondary	Hyperglycemia	Percentage of values >250 mg/dL	12 weeks for each arm of the crossover
Secondary	HbA1c	HbA1c	12 weeks for each arm of the crossover
Secondary	Hypoglycemia Unawareness	Gold survey	12 weeks for each arm of the crossover