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

NCT04016662 | Completed Phase 4 Results DMC FDA Device

• 1 other identifier: AIDE T1D
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 4

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 (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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• CGM Measured Time <70 mg/dL

  Primary Outcome: Percentage of sensor glucose values \<70 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. Since the hypoglycemia endpoints had skewed distributions, values were winsorized at the 10th and 90th percentiles.

  weeks 5-12 of 12 weeks for each intervention of the crossover

Secondary Outcomes (9)

• CGM Measured Time <54 mg/dL

  weeks 5-12 of 12 weeks for each intervention of the crossover

• Hypoglycemia

  weeks 5-12 of 12 weeks for each arm of the crossover

• Glucose Control

  weeks 5-12 of 12 weeks for each arm of the crossover

• % Time 70-180 mg/dL

  weeks 5-12 of 12 weeks for each intervention of the crossover

• Glucose Control - Coefficient of Variation

  weeks 5-12 of 12 weeks for each arm of the crossover

Other Outcomes (5)

• Patient Reported Questionnaires - Hypoglycemia Fear Survey

  at 12 week visit for each arm of the crossover

• Patient Reported Questionnaires - Hypoglycemia Confidence

  at 12 week visit for each arm of the crossover

• Patient Reported Questionnaires - Diabetes Distress Scale

  at 12 week visit for each arm of the crossover

Study Arms (3)

Hybrid Closed Loop Control (HCL)

ACTIVE COMPARATOR

The HCL intervention arm will utilize the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM

Device: Tandem t:slim X2 with HCL or PLGS

Predictive Low-Glucose Insulin Suspension (PLGS)

ACTIVE COMPARATOR

The PLGS intervention arm will utilize the Tandem t:slim X2 with Basal-IQ Technology and Dexcom G6 CGM

Device: Tandem t:slim X2 with HCL or PLGS

Sensor-Augmented Pump (SAP)

NO INTERVENTION

The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM

Interventions

Tandem t:slim X2 with HCL or PLGS DEVICE

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.

Also known as: Tandem t:slim X2 with Control-IQ Technology, Tandem t:slim X2 with Basal-IQ Technology

Hybrid Closed Loop Control (HCL); Predictive Low-Glucose Insulin Suspension (PLGS)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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

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
• 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

Sponsors & Collaborators

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

Study Sites (4)

AdventHealth Diabetes Institute

Orlando, Florida, 32803, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

SUNY Upstate

Syracuse, New York, 13214, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Kudva YC, Henderson RJ, Kanapka LG, Weinstock RS, Rickels MR, Pratley RE, Chaytor N, Janess K, Desjardins D, Pattan V, Peleckis AJ, Casu A, Rizvi SR, Bzdick S, Whitaker KJ, Kamimoto JLJ, Miller K, Kollman C, Beck RW; AIDE Study Group. Automated Insulin Delivery in Elderly with Type 1 Diabetes: A Prespecified Analysis of the Extension Phase. Diabetes Technol Ther. 2025 Jul;27(7):572-575. doi: 10.1089/dia.2024.0560. Epub 2025 Mar 11.

  PMID: 40067490 DERIVED

• Kudva YC, Henderson RJ, Kanapka LG, Weinstock RS, Rickels MR, Pratley RE, Chaytor N, Janess K, Desjardins D, Pattan V, Peleckis AJ, Casu A, Rizvi SR, Bzdick S, Whitaker KJ, Jo Kamimoto JL, Miller K, Kollman C, Beck RW. Automated Insulin Delivery in Older Adults with Type 1 Diabetes. NEJM Evid. 2025 Jan;4(1):EVIDoa2400200. doi: 10.1056/EVIDoa2400200. Epub 2024 Dec 23.

  PMID: 39714936 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Robert Henderson
• Organization: Jaeb Center for Health Research

Rhenderson@jaeb.org

(813) 975-8690

Study Officials

• Robert Henderson, MS

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized crossover trial with three 12-week crossover periods (HCL during one period, PLGS during one period, and SAP therapy (control) during one period) preceded by a run-in phase.

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 11, 2019
• Study Start: September 28, 2020
• Primary Completion: September 14, 2023
• Study Completion: January 5, 2024
• Last Updated: January 15, 2025
• Results First Posted: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available after publication of the primary manuscript and will remain available in perpetuity
• Access Criteria: users must have a valid email address

Locations

US (4)