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Type 1 Diabetes MellitusPhase 4AIDE T1DNCT04016662

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

A Phase 4 study testing Tandem t:slim X2 with HCL or PLGS in people with Type 1 Diabetes Mellitus, run by Jaeb Center for Health Research at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Tandem t:slim X2 with HCL or PLGS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
4 sitesUnited States
Study dates
28 Sep 2020to 5 Jan 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • AdventHealth Diabetes Institute

    Orlando, Florida, 32803

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • SUNY Upstate

    Syracuse, New York, 13214

Other trials in United States

About this study

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

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.

Read the 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 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.

Being tested
Tandem t:slim X2 with HCL or PLGS
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tandem t:slim X2 with HCL or PLGSDevice

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

    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.

Study groups in NCT04016662
Study groupRoleWhat they receive
Hybrid Closed Loop Control (HCL)Active comparatorThe HCL intervention arm will utilize the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM
Receives: Device: Tandem t:slim X2 with HCL or PLGS
Predictive Low-Glucose Insulin Suspension (PLGS)Active comparatorThe PLGS intervention arm will utilize the Tandem t:slim X2 with Basal-IQ Technology and Dexcom G6 CGM
Receives: Device: Tandem t:slim X2 with HCL or PLGS
Sensor-Augmented Pump (SAP)No interventionThe SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (9)

  1. CGM Measured Time <54 mg/dL

    Percentage of sensor glucose values <54 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.

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

  2. Hypoglycemia

    Rate of CGM-measured hypoglycemic events per week. A hypoglycemic event is defined as 15 consecutive minutes with a sensor glucose value <54 mg/dl. At least 2 sensor values <54 mg/dl that are 15 or more minutes apart plus no intervening values >54 mg/dl are required to define an event. The end of the hypoglycemic event is defined as a minimum of 15 consecutive minutes with a sensor glucose concentration >70 mg/dl. At least 2 sensor values >70 mg/dl that are 15 or more minutes apart with no intervening values <70 mg/dl, are required to define the end of an event. When a hypoglycemic event ends, the study participant becomes eligible for a new event.

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

  3. Glucose Control

    Mean glucose (mg/dL)

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

  4. % Time 70-180 mg/dL

    Percentage of sensor glucose values 70 to 180 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.

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

  5. Glucose Control - Coefficient of Variation

    Coefficient of variation (%)

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

  6. % Time > 180 mg/dL

    Percentage of values >180 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.

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

  7. % Time > 250 mg/dL

    Percentage of values >250 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.

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

  8. HbA1c

    HbA1c %

    Measured: at 12 week visit for each arm of the crossover

  9. Hypoglycemia Unawareness - Gold Survey

    The Gold score asks subjects to indicate their awareness of hypoglycemia with '1' being always aware and '7' being never aware.

    Score scale 1-7; A higher score indicates more unawareness.

    Measured: at 12 week visit for each arm of the crossover

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2019
  2. Study start28 Sep 2020
  3. Primary completion14 Sep 2023
  4. Study completion5 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04016662
Sponsor's protocol ID
AIDE T1D
Acronym
AIDE T1D
Status last verified
Dec 2024
First submitted
9 Jul 2019
Last updated
15 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: deidentified data will be shared on the JCHR website

Publications

  • 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.

    PubMed 40067490

  • 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.

    PubMed 39714936

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tandem t:slim X2 with HCL or PLGS in people with Type 1 Diabetes Mellitus, run by Jaeb Center for Health Research at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CGM Measured Time <70 mg/dL (time frame: weeks 5-12 of 12 weeks for each intervention of the crossover). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04016662, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.

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