Smartphone-Based Control System for Type 1 Diabetes

Recruiting at 2 trial locations

Overseen By Sara Prince, RN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Mark D. DeBoer, MD, MSc., MCR

Must be taking: Insulin

Must not be taking: SGLT-2 inhibitors, Steroids

Disqualifiers: Seizure disorder, Heart condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new diabetes management system that uses a modified insulin pump, a continuous glucose monitor (CGM), and a smartphone app. Researchers aim to determine if this system can better control blood sugar levels in children with type 1 diabetes. Participants will try different approaches, including maintaining glucose levels at normal or tight goals, with usual care periods before and after. Ideal candidates are children aged 6-13 who have used an insulin pump and a Dexcom CGM for at least three months and have had type 1 diabetes for over a year. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes care solutions for children.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not start any new non-insulin glucose-lowering medications during the study. If you are already on a stable dose of such a medication, you may continue it. However, you cannot use SGLT-2 or SGLT-1/2 inhibitors.

What prior data suggests that the AIDANET algorithm and its components are safe?

Research has shown that the AIDANET system is generally safe for managing blood sugar levels, whether aiming for normal or tight control. A small initial study with six participants found that the system safely managed their blood sugar, but more research with a larger group is needed to confirm these results.

Another study found that the AIDANET system can function without users needing to announce meals, which benefits people with Type 1 Diabetes. This feature aims to make the system easier to use.

Overall, early findings suggest the system is well-tolerated, but more data is needed for confirmation. For those considering joining a trial with this system, early research indicates it is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AIDANET Pediatrics trial because it explores a novel approach to managing blood sugar in children with diabetes. Unlike standard treatments that often rely on manual monitoring and insulin injections, the AIDANET system is an automated method designed to maintain more precise glycemic control. It tests two different glycemia goals—normal and tight—potentially offering more tailored and effective management of blood sugar levels. This trial could lead to advancements in pediatric diabetes care by enhancing safety and optimizing glucose control, which are crucial for long-term health outcomes.

What evidence suggests that the AIDANET system with smartphone control, insulin pump, and CGM could be effective for glycemia management?

Research has shown that the AIDANET system can improve blood sugar control. In one study, participants using the system had an average blood sugar level of 161.3 mg/dL, compared to 168 mg/dL with their usual care, indicating better overall management. Another study found that automated insulin delivery systems, like AIDANET, help maintain blood sugar levels within a healthy range more frequently. In this trial, participants will use the AIDANET system with either a Normal Glycemia Goal or a Tight Glycemia Goal, both of which have demonstrated positive results in previous studies. These findings suggest the system may effectively manage blood sugar levels in people with diabetes. ^{1 2 5 6 7}

Who Is on the Research Team?

Mark DeBoer, MD

Principal Investigator

University of Virginia Center for Diabetes Technology

Are You a Good Fit for This Trial?

Inclusion Criteria

I am currently using a Dexcom G6 or G7 CGM.

I am between 6 and 13 years old.

I have been diagnosed with type 1 diabetes for over a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care Control Period

Participants complete two weeks of usual care before using the AIDANET system

2 weeks

AIDANET System Usage

Participants use the AIDANET system with either Normal or Tight Glycemia Goal

2 weeks

Usual Care Control Period

Participants complete two weeks of usual care after using the AIDANET system

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tandem insulin system

How Is the Trial Designed?

Group I: Usual Care before experimental system; system with Tight Glycemia Goal Experimental Treatment 1 Intervention

Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Tight Glycemia Goal.

Group II: Usual Care before experimental system; system with Normal Glycemia Goal Experimental Treatment 1 Intervention

Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Normal Glycemia Goal.

Group III: Usual Care after experimental system; system with Tight Glycemia Goal Experimental Treatment 1 Intervention

Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Tight Glycemia Goal.

Group IV: Usual Care after experimental system; system with Normal Glycemia Goal Experimental Treatment 1 Intervention

Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Normal Glycemia Goal.

Who Is Running the Clinical Trial?

Mark D. DeBoer, MD, MSc., MCR

Lead Sponsor

Tandem Diabetes Care, Inc.

Industry Sponsor

Trials

43

Recruited

5,800+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12479459/

A Pilot Study Featuring Flexible Meal Announcement Options The mean glucose during usual care was 168 ± 24.3 mg/dL, compared to 161.3 ± 16.7 mg/dL using the AIDANET system. Time-in-range (TIR) 70 to 180 ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06728059

Safety and Feasibility of a Machine-Learning Bolus Priming ... This is a research study about the UVA Automated Insulin Delivery System known as Adaptive NETwork (AIDANET). This system consists of a Reinforcement Learning ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07039617

Study Details | NCT07039617 | AIDANET At Home Study A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12017971/

Efficacy of automated insulin delivery systems in people with ... The results showed that AID systems were beneficial to varying degrees with respect to the percentage of time in the range of 70–180 mg/dl and ...

5. researchgate.net researchgate.net/publication/396282928_User_Experiences_of_a_Bihormonal_Fully_Closed-Loop_System_Among_Adults_with_Type_1_Diabetes_in_a_Real-World_Setting_A_Qualitative_Analysis

User Experiences of a Bihormonal Fully Closed-Loop ... AHCL system in adults significantly improves glycemic outcomes. This improved glycemic control was maintained over the 12 months. Switching ...

6. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/962-P/159109/962-P-Evaluating-Type-1-Diabetes-T1D-Care-across

962-P: Evaluating Type 1 Diabetes (T1D) Care across All ... The AIDANET system uses an adaptive algorithm that removes the need for meal announcement. This may help address age-specific obstacles in T1D.

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07020936

AIDANET Pediatrics - UCSF Diabetes Trial This study aims to demonstrate the safety and feasibility of the Automated insulin delivery as Adaptive NETwork (AIDANET) system among children age 6-13 ...