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

30 Participants Needed

Trial Summary

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 safety data exists for the SPACE Intervention for Type 1 Diabetes?

The safety of hybrid closed-loop insulin delivery systems, which may be similar to the SPACE Intervention, has been evaluated in adolescents with type 1 diabetes, showing they are generally safe for use in free-living conditions. ^{1 2 3 4 5}

How does the SPACE treatment for type 1 diabetes differ from other treatments?

The SPACE treatment for type 1 diabetes is unique because it may involve innovative approaches like using stem cells to replace insulin-producing cells, potentially reducing the need for lifelong insulin injections. This differs from traditional treatments that primarily rely on insulin administration and does not address the underlying cause of the disease. ^{5 6 7 8 9}

What is the purpose of this trial?

This is a pilot trial of a school-partnered collaborative care (SPACE) model for pediatric type 1 diabetes. The trial will investigate the feasibility and acceptability of SPACE for children with type 1 diabetes in the school setting. SPACE is adapted from a collaborative care model used to treat depression and other mental health care conditions in adolescents and adults.

Research Team

Christine A March, MD

Principal Investigator

Univeristy of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

An Atmosphere-Breathing Refillable Biphasic Device for Cell Replacement Therapy. [2023]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Islet Encapsulation: Physiological Possibilities and Limitations. [2018]

5. United States 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. [2022]

6. United States 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. [2020]

7. Denmark pubmed.ncbi.nlm.nih.gov

Pancreatic stem cells: a therapeutic agent that may offer the best approach for curing type 1 diabetes. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Toward cell-based therapy of type I diabetes. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Transforming type 1 diabetes: the next wave of innovation. [2022]