SPACE Intervention for Type 1 Diabetes

(SPACE Trial)

Overseen By Christine A March, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Developmental delay, Neuropsychiatric disorder, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to support children with type 1 diabetes at school. It evaluates how well a collaborative care model, initially used for mental health, manages diabetes through virtual meetings. The study compares a group receiving usual care with a group participating in the SPACE intervention, a structured program for diabetes management involving school nurses, parents, and diabetes specialists. Children who have had type 1 diabetes for at least six months, attend a participating school, and require daily assistance from a school nurse may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes care strategies in schools.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on managing diabetes care in a school setting, so it's best to ask the trial coordinators for more details.

What prior data suggests that the SPACE model is safe for children with type 1 diabetes?

Research has shown that the SPACE program for type 1 diabetes is based on a model used in mental health care, ensuring its design prioritizes safety. The program, which is non-invasive and centers on online meetings and teamwork, poses no risk of physical harm, unlike drug trials. It involves regular communication among a school nurse, a diabetes care expert, and the family to manage diabetes effectively.

While specific safety data for the SPACE program is not available, similar teamwork-based models have been used successfully without major issues, suggesting the program is likely safe and well-received. Additionally, this trial is in a "not applicable" phase, indicating it is an early study focused on the program's practicality and acceptability, rather than testing a new drug or device. This phase typically carries a lower risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SPACE Intervention for Type 1 Diabetes because it emphasizes a collaborative approach between families, healthcare providers, and school staff. Unlike traditional treatments that focus solely on medical management, this intervention integrates educational and social support systems, fostering a holistic care environment. By involving school nurses and diabetes care specialists in regular virtual meetings, the intervention aims to create personalized treatment plans that address both health and academic needs, potentially leading to better management and outcomes for children with Type 1 Diabetes.

What evidence suggests that the SPACE model is effective for managing type 1 diabetes in children?

Research has shown that programs like SPACE, which collaborate with schools, can improve the health of children with type 1 diabetes. In this trial, the SPACE Intervention includes regular online meetings with school nurses and diabetes specialists to discuss treatment plans and monitor glucose levels. This method, tested in the current trial, involves setting and achieving treatment goals, potentially enhancing diabetes management. Although evidence remains limited, this approach draws on successful methods used for mental health. Meanwhile, the control group will receive usual care with additional support through monthly phone calls, providing a comparison to evaluate the effectiveness of the SPACE Intervention. ^{1 2 6 7 8}

Who Is on the Research Team?

Christine A March, MD

Principal Investigator

Univeristy of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for children with Type 1 Diabetes. It's designed to test a new care model called SPACE, which involves schools in managing diabetes. To join, kids must have Type 1 Diabetes and be attending school where the program will take place.

Inclusion Criteria

I have been diagnosed with type 1 diabetes for over 6 months.

Managed by the Children's Hospital of Pittsburgh Diabetes center

I get daily help from a school nurse for my diabetes.

Exclusion Criteria

My child manages their diabetes on their own at school.

Child has developmental delay or neuropsychiatric disorder which would preclude their participation in their diabetes care and/or completion of study questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Four monthly virtual meetings between the child, school nurse, diabetes care and education specialist (DCES), and other school-related support people to determine a shared treatment plan and make treatment recommendations

4 months

4 virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and data collection from glucometers and electronic health records

1 month

What Are the Treatments Tested in This Trial?

Interventions

• SPACE for T1D

Trial Overview

The trial is testing the SPACE intervention against enhanced usual care for managing Type 1 Diabetes in children at school. Researchers want to see if SPACE is doable and helpful in this setting.

How Is the Trial Designed?

Group I: SPACE Intervention Experimental Treatment 1 Intervention

The intervention consists of four monthly virtual visits between the school nurse, diabetes care and education specialist (DCES), parent, and any other school-related supports identified by the parent (e.g., coaches, counselors, social workers). At the first visit, the parent and child, school nurse, and DCES will discuss and determine a shared treatment plan. This will include a diabetes medical management plan and shared treatment goals for the child. At each virtual visit, the DCES and school nurse will co-lead the group through review of the shared treatment plan, a review of glucose records and insulin dosing for diabetes management, provide counseling/education, and identify any needed internal (academic) or external (health-related) supports or referrals. Families will be encouraged to set new treatment goals if any milestones are met.

Group II: Control Active Control 1 Intervention

In addition to usual care (clinical and in school), parents of children enrolled in the control group will receive four monthly phone calls from the DCES to review diabetes management, mirroring the timing of the virtual visits of the intervention group. This study will employ a wait list control.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The study demonstrated that a day-and-night hybrid closed-loop insulin delivery system significantly improved glucose control in adolescents with type 1 diabetes, increasing the time spent in the target glucose range by nearly 19% compared to traditional sensor-augmented insulin pump therapy.

The closed-loop system was found to be safe and feasible for home use, with no increase in hypoglycemia risk, while also requiring a slightly higher total daily insulin dose, indicating its effectiveness in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial. Tauschmann, M., Allen, JM., Wilinska, ME., et al.[2022]

Despite extensive research over the last 2-3 decades, effective methods to cure Type 1 Diabetes (T1D) through cell substitution therapy remain elusive, with most patients still reliant on insulin injections.

Current clinical trials, including pancreatic islet cell transplantation, have shown limited success, highlighting the need for new advancements in cell and molecular therapies, such as stem cell approaches, to potentially achieve a cure for T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stem cells for the cell and molecular therapy of type 1 diabetes mellitus (T1D): the gap between dream and reality. Calafiore, R., Basta, G.[2020]

A study involving 12 adolescents with type 1 diabetes showed that hybrid closed-loop insulin delivery significantly improved glucose control, increasing the time spent in the target glucose range from 53% to 72% compared to sensor-augmented pump therapy.

The closed-loop system effectively lowered mean glucose levels and reduced time spent above the target range without increasing the risk of hypoglycemia, demonstrating its feasibility and safety for unsupervised use in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Day-and-Night Hybrid Closed-Loop Insulin Delivery in Adolescents With Type 1 Diabetes: A Free-Living, Randomized Clinical Trial. Tauschmann, M., Allen, JM., Wilinska, ME., et al.[2022]

Citations

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SPACE Intervention for Type 1 Diabetes (SPACE Trial)

The study demonstrated that a day-and-night hybrid closed-loop insulin delivery system significantly improved glucose control in adolescents with type 1 ...

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Early Results of an Innovative Scalable Digital Treatment ...

Objective: This paper reports on the initial outcomes of a new mHealth intervention to reduce diabetes distress (DD) in families of school-age ...

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The Pediatric Artificial Pancreas Automated Initialization Trial

The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system ...

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sciencedirect.com/science/article/abs/pii/S088985291200093X

Update on Global Intervention Studies in Type 1 Diabetes

Furthermore, early prevention therapies must be extremely safe as they would be administered to people who may never actually develop T1D. In addition, many of ...