Continuous Glucose Monitoring for Type 1 Diabetes

(NIDDK T1D Trial)

Overseen By Bruno Gonzales, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Continuous glucose monitoring

Disqualifiers: Renal disease, Dementia, Psychiatric, others

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

Compensation: Varies

Number of Visits: 3

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Share plus to determine if it helps people with type 1 diabetes manage their blood sugar better through continuous glucose monitoring. The program aims to enhance how individuals with diabetes and their care partners share glucose data and communicate. The trial compares the Share plus group with a control group receiving standard diabetes education. Ideal candidates for this trial are individuals over 60 with type 1 diabetes who already use continuous glucose monitors and manage their diabetes with insulin. As an unphased trial, this study allows participants to contribute to innovative diabetes management strategies.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using a medication that the investigator believes might affect the study, it could be a concern.

What prior data suggests that this Share plus intervention is safe for continuous glucose monitoring?

Research shows that the Share plus program is well-received by participants. Previous studies found that this program, which uses a continuous glucose monitor and a data-sharing app, is practical and participants express high satisfaction with it. These studies reported no major side effects, indicating the program's safety. Delivered through telehealth, it aims to enhance communication and problem-solving between people with diabetes and their care partners. Overall, evidence suggests that the Share plus program can safely and effectively help manage diabetes without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Share plus intervention for continuous glucose monitoring in Type 1 Diabetes because it offers a unique approach to managing the condition. Unlike traditional treatments, which often focus solely on medication and monitoring devices, Share plus emphasizes behavioral change through telehealth. It features motivational interviewing techniques to improve communication and problem-solving strategies in patient-caregiver dyads. This personalized, educational approach aims to enhance the effectiveness of existing diabetes management tools by fostering better data sharing and action planning, potentially leading to improved glucose control and quality of life for patients.

What evidence suggests that the Share plus intervention is effective for improving continuous glucose monitoring in Type 1 Diabetes?

In this trial, participants in the intervention group will receive the Share plus intervention. Research has shown that this method can help people with type 1 diabetes manage their blood sugar levels more effectively. The approach uses a device that continuously monitors blood sugar and an app that allows care partners to view this information on their smartphones. Early studies suggest that this method enhances communication and problem-solving between patients and their care partners. By improving these skills, the intervention aims to help patients maintain their blood sugar within the target range more frequently and reduce stress related to diabetes. Initial results are promising, indicating potential benefits in managing diabetes more effectively. ^{1 2 3 4 6}

Who Is on the Research Team?

Nancy A Allen, PhD

Principal Investigator

University of Utah College of Nursing

Are You a Good Fit for This Trial?

This trial is for older adults aged 60 and above with Type 1 Diabetes, who have an HbA1c level between 7.5% to 11%, use continuous glucose monitoring, and can manage their diabetes (possibly with help from a care partner). They must be new to the Follow app but willing to use it.

Inclusion Criteria

I have been diagnosed with Type 1 Diabetes.

HbA1c greater than or equal to 7.5% and less than or equal to 11%

I am 60 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Share plus intervention, which includes three educational sessions to facilitate dyads' success in data sharing glucose levels.

12 weeks

3 virtual sessions

Observation

Participants are observed to determine maintenance of changes in primary outcomes.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Share plus intervention

Trial Overview The study tests the 'Share plus intervention', which focuses on sharing data between people with diabetes and their care partners using continuous glucose monitoring. The goal is to improve time spent in the ideal blood sugar range and reduce stress related to managing diabetes.

How Is the Trial Designed?

Group I: Intervention Group- Virtual with Dyad Follow + Share plus Experimental Treatment 1 Intervention

The Share plus intervention is a behavioral intervention administered by a certified diabetes education and care specialist (CDCES) using telehealth. Share plus consists of three educational sessions to facilitate dyads' success in data sharing glucose levels. The Share plus intervention has five major components that are delivered using techniques of motivational interviewing: 1) shared appraisal, 2) communication strategies, 3) problem-solving strategies, 4) action planning and, 5) re-evaluating, practicing, and advancing.

Group II: Control Group- Virtual with Dyad Follow + Diabetes Self-Management Education Active Control 1 Intervention

Participants will receive diabetes self-management education using the Association of Diabetes Care and Education Specialists 7 education curriculum (ADCES7).

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Caregivers of individuals with type 1 diabetes reported significant improvements in their quality of life (QoL) due to real-time continuous glucose monitoring (RT-CGM) data sharing, with 97.7% of parents and 98.1% of partners feeling more confident in managing hypoglycemia.

Key caregiver actions, such as celebrating glycemic control successes and discussing responses to out-of-range values, were linked to enhanced QoL and health outcomes, highlighting the importance of collaboration in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Real-Time CGM Data Sharing on Quality of Life in the Caregivers of Adults and Children With Type 1 Diabetes. Polonsky, WH., Fortmann, AL.[2022]

Continuous glucose monitors (CGMs) can significantly improve diabetes management by providing valuable data for tracking and analysis, leading to better health outcomes.

However, there are serious concerns regarding patient privacy and cybersecurity, as current protections are insufficient to safeguard personal information and ensure physical security, which could hinder the benefits of CGM technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Privacy and Security Issues Surrounding the Protection of Data Generated by Continuous Glucose Monitors. Britton, KE., Britton-Colonnese, JD.[2018]

In a study of 81 youths with type 1 diabetes, using a glucometer-connected mobile app increased the frequency of self-monitoring blood glucose (SMBG) by 2.3 times with each additional data sync, indicating improved engagement in diabetes self-management.

However, the frequency of syncing glucometer data did not show a significant impact on hemoglobin A1c (HbA1c) levels or mean blood glucose, suggesting that while the app may enhance monitoring habits, its effect on overall glycemic control is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. Clements, MA., Staggs, VS.[2018]

Real-time continuous glucose monitoring (RT-CGM) data sharing enhances feelings of safety for individuals with diabetes and their care partners, fostering a sense of support in managing the condition.

However, sharing RT-CGM data can complicate relationships, highlighting the importance of clear communication about boundaries and expectations between patients and care partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Analysis of Real-Time Continuous Glucose Monitoring Data Sharing with Care Partners: To Share or Not to Share? Litchman, ML., Allen, NA., Colicchio, VD., et al.[2018]

The SHARE plus intervention, which includes communication and problem-solving strategies, was found to be feasible for older adults with type 1 diabetes and their care partners, leading to high satisfaction and adherence to continuous glucose monitoring (CGM) at 96%.

Participants reported improvements in diabetes-related quality of life, and while most were open to discussing glucose levels with their care partners, some hesitated to share hyperglycemia data, indicating a need for further support in data sharing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring Data Sharing in Older Adults With Type 1 Diabetes: Pilot Intervention Study. Allen, NA., Litchman, ML., Chamberlain, J., et al.[2023]

In a study of 15,000 youth with diabetes, 94.8% utilized a continuous glucose monitoring (CGM) system's real-time sharing feature, which was linked to improved glycemic control.

Having at least one 'Follower' (a caregiver monitoring the data) was associated with lower average glucose levels and fewer instances of hypoglycemia and hyperglycemia, indicating that real-time sharing may enhance diabetes management through increased engagement and timely interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Sharing and Following of Continuous Glucose Monitoring Data in Youth. Welsh, JB., Derdzinski, M., Parker, AS., et al.[2023]

In a study of 302 adults with type 1 diabetes using real-time continuous glucose monitoring (RT-CGM), data sharing with family or friends significantly improved health outcomes, including increased hypoglycemic confidence (89.4% of respondents) and reduced diabetes distress (36.1%).

Positive actions from chief followers, such as celebrating successes and providing encouragement, were linked to better health and quality of life outcomes, suggesting that collaborative management can enhance the effectiveness of diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Real-Time Continuous Glucose Monitoring Data Sharing on Quality of Life and Health Outcomes in Adults with Type 1 Diabetes. Polonsky, WH., Fortmann, AL.[2021]

In a study of 117 patients with diabetes who used continuous glucose monitoring (CGM) for an average of 9.7 months, there was a significant reduction in hemoglobin A1c levels from 7.6% to 7.2%, indicating improved glucose control.

CGM use was associated with a 60% reduction in the rate of severe hypoglycemic episodes, demonstrating its effectiveness in enhancing patient safety and managing diabetes in a real-world setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of continuous glucose monitor use in clinical practice. Leinung, M., Thompson, S., Nardacci, E.[2022]

Citations

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Examining Share plus-A Continuous Glucose Monitoring Plus ... Conclusions: To our knowledge, this will be the first pilot randomized controlled trial to evaluate both feasibility and effectiveness outcomes ...

2. researchprotocols.org researchprotocols.org/2024/1/e60004

Examining Share plus—A Continuous Glucose Monitoring ... This is a protocol for a feasibility, pilot randomized controlled trial. Older adults with T1D and their CP (N=80 dyads) will be randomized 1:1 to the Share ...

3. diabetes.jmir.org diabetes.jmir.org/2022/1/e35687/

Continuous Glucose Monitoring Data Sharing in Older Adults ... This study aimed to address the barriers to sharing CGM data. Our objective was to examine the feasibility of using CGM with the Follow app and a data-sharing ...

4. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074824006231

Examining Share plus—A Continuous Glucose Monitoring ... The Share plus intervention framed by the Dyadic Coping Model begins with a discussion of how persons with diabetes and CPs appraise diabetes ( ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37345621/

Continuous glucose monitoring with data sharing in older ... The SHARE plus intervention includes continuous glucose monitoring with a data sharing app that allows care partners to view glucose data on a smartphone and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8914598/

SHARE plus: Delivering a Telehealth CGM Data ... This article describes a study confirming the feasibility of SHARE plus, a telehealth intervention involving continuous glucose monitoring and data-sharing.