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A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET At Home)

ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSue Brown

About this trial

A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: AIDANET-Fully Closed Loop (FCL), AIDANET-Hybrid Closed Loop (HCL) and AIDANET allowing a mix between FCL and HCL. There will be an Automated Insulin Delivery (AID) phase with participants using their home devices and/or study continuous glucose monitor (CGM) and study-provided commercial Mobi system without AIDANET.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18.0 years old at time of consent

Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year.

Having used an Food and Drug Administration (FDA) approved AID system within the last six months (can be intermittent use).

Currently using insulin for at least six months.

Disqualifiers

Plans to start a new non-insulin glucose-lowering agent (e.g. glucagon-like peptide-1 (GLP-1) receptor agonists, Symlin, (DPP-4 inhibitors, also known as dipeptidyl peptidase 4). Participants may be on a stable dose of such an agent for at least the past month.

Current use of sulfonylurea medications.

Current use of an Sodium-Glucose Cotransporter 2 (also known as a SGLT-2 or SGLT-1/2 inhibitor) due to risk of euglycemic diabetic ketoacidosis (DKA).

Hemophilia or any other bleeding disorder.

Trial design

Design model

Crossover

Treatments tested in this trial

  • AIDANET + FCL

    Device

    All participants will use AIDANET in fully closed loop (FCL) mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.

  • AIDANET + HCL

    Device

    All participants will use AIDANET in hybrid closed loop (HCL) mode with instructions to announce all meal boluses using carbohydrate counting or easy bolus during the four weeks. All components of AIDANET will remain active during this phase but BPS in particular is expected to be triggered less often due to meal announcements.

  • AIDANET in FCL-HCL-mixed mode

    Device

    All participants will use AIDANET with instructions to choose whether to use fully closed loop (FCL) or hybrid closed loop (HCL) mode with meal announcements (carb counting or easy bolus) per their discretion each day.

  • Automated Insulin Delivery (AID) (usual care)

    Other intervention

    Participants will manage their diabetes as they normally do at home.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 4 interventions
Group B: Group BExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Time in Range (70-180 mg/dL)

* Computed as the number of estimated glucose values ≥70mg/dL and \<180mg/dL divided by the number of valid values (defined as a number between 39 and 401) * Outcome is computed if: * \>4032 values are recorded (availability condition, 2 weeks equivalent) * AND there is \>70% values between the first recorded EGV of the analysis window and the last (density condition)

Time frame
16 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sue Brown

Lead sponsor

University of Virginia

Sponsor institution

Tandem Diabetes Care, Inc.

Collaborator

DexCom, Inc.

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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