Continuous Glucose Monitoring for Type 1 Diabetes

(NIDDK T1D Trial)

Overseen By Bruno Gonzales, BA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Utah

Must be taking: Continuous glucose monitoring

Disqualifiers: Renal disease, Dementia, Psychiatric, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the Share plus intervention aimed at improving the use of data sharing between people with diabetes and their care partners in order to maximize the benefits of continuous glucose monitoring. Hypothesis: Compared to the control group, persons with diabetes enrolled in the Share plus intervention group will experience clinically significant improvements in time-in-range (TIR) (\>5%) at 12- and 24-weeks into the study, and improvement on diabetes distress. Care partners enrolled in the Share plus intervention group will experience lower diabetes distress at 12- and 24-weeks into the study.

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 data supports the effectiveness of the treatment Continuous Glucose Monitoring with Data Sharing for Type 1 Diabetes?

Research shows that sharing real-time glucose data with family or friends can improve confidence in managing low blood sugar, overall well-being, and reduce diabetes-related stress. It also leads to fewer severe low blood sugar episodes, better sleep, and improved blood sugar control. ^{1 2 3 4 5}

Is continuous glucose monitoring with data sharing safe for humans?

Continuous glucose monitoring with data sharing has been associated with health benefits like improved well-being and fewer severe low blood sugar episodes, but there are concerns about data privacy and security that need to be addressed to ensure patient safety. ^{1 2 3 6 7}

How is the Continuous Glucose Monitoring with Data Sharing App treatment different from other treatments for type 1 diabetes?

This treatment is unique because it allows people with type 1 diabetes to share their real-time glucose levels with family or friends through a smartphone app, which can improve their quality of life and health outcomes by providing support and reducing stress. ^{1 2 3 7 8}

Research Team

Nancy A Allen, PhD

Principal Investigator

University of Utah College of Nursing

Eligibility Criteria

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 18 years old or older.

Trial Timeline

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

Treatment Details

Interventions

• Share plus intervention (Behavioural 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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. United States 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. [2022]

3. United States 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? [2018]

4. United States 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. [2018]

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

Benefits of continuous glucose monitor use in clinical practice. [2022]

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

Privacy and Security Issues Surrounding the Protection of Data Generated by Continuous Glucose Monitors. [2018]

7. Canada pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring Data Sharing in Older Adults With Type 1 Diabetes: Pilot Intervention Study. [2023]

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

Real-Time Sharing and Following of Continuous Glucose Monitoring Data in Youth. [2023]