144 Participants NeededMy employer runs this trial

CGM Integration Program for Diabetes

(INSIDE-CGM Trial)

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Overseen ByAngela Fruik, MPH, RD, LDN
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well different training programs help older adults using insulin integrate continuous glucose monitors (CGMs) into their daily lives. Researchers will randomly divide participants into three groups to test various training methods: a detailed multi-session program (three-stage CGM integration program), a one-time clinic session, and self-guided learning with a pamphlet. The goal is to determine if these training methods improve CGM usage, blood sugar management, and participants' feelings about their diabetes care. The trial seeks adults aged 65 and older who use insulin, have not used a CGM in the past year, and are open to using a smartphone for glucose readings. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance diabetes care for older adults.

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

The trial information does not specify if you need to stop taking your current medications. However, if a medication might affect your ability to complete the study, the investigator may decide it's best not to include you in the trial.

What prior data suggests that this CGM integration program is safe for older adults taking insulin?

Research shows that the three-stage continuous glucose monitor (CGM) program is generally easy for participants to handle. Previous studies have found that programs using CGM devices, like the one in this study, usually have manageable side effects. These devices help people with diabetes monitor their blood sugar levels in real-time and are commonly used in diabetes care.

Although specific details on side effects for this exact program are not available, similar CGM systems have been safely used in other studies and are approved for managing diabetes. These programs aim to help users understand and control their blood sugar levels with minimal discomfort. Participants typically adapt well to the CGM technology, with only minor and infrequent issues reported.12345

Why are researchers excited about this trial?

Researchers are excited about the CGM Integration Program for diabetes because it offers a structured, three-stage approach to continuous glucose monitor (CGM) integration, setting it apart from current options. Unlike standard methods, which often rely on self-directed or one-time training, this program provides a more comprehensive and supportive framework for users. By gradually guiding individuals through the stages of CGM use, the program aims to enhance user proficiency and confidence, potentially leading to better blood sugar management. This innovative approach could result in improved outcomes for people with diabetes, making it a promising development in diabetes care.

What evidence suggests that this trial's CGM integration program could be effective for diabetes?

Research has shown that continuous glucose monitors (CGMs) effectively manage diabetes. They help lower HbA1C levels, leading to better long-term blood sugar control. Studies indicate that CGMs enable people to maintain their blood sugar within a healthy range more often and reduce episodes of dangerously low blood sugar. Some CGMs provide real-time data, further enhancing blood sugar management. Overall, using a CGM simplifies tracking and managing diabetes, resulting in better health outcomes.

In this trial, participants will join one of three study arms: the Three-stage CGM integration program, Self-directed CGM training, or One-time clinic-based CGM training. Each approach evaluates different methods of CGM training and integration to identify the most effective strategy for diabetes management.16789

Who Is on the Research Team?

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Anna Kahkoska, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for adults aged 65 and older with type 1 or type 2 diabetes who use insulin, get regular care at UNC clinics within a 90-mile radius of Chapel Hill, NC, are willing to use a smartphone app for glucose readings, haven't used a CGM in the past year, and speak English.

Inclusion Criteria

I am willing to use a smartphone app to check my glucose readings.
I am 65 years old or older.
* Actively receiving care at a UNC Health or UNC Physicians Network clinic (defined as 2 or more visits in primary care, family medicine, internal medicine, geriatrics, or endocrinology clinics within the past 365 days). Locality for care is defined as residing within a 90-mile radius of UNC Main Hospital on Manning Drive in Chapel Hill, NC.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline Data Collection

Baseline data collection occurs before randomization

1 week
1 visit (in-person)

Treatment

Participants are randomized to intervention or comparator arms for CGM training over 6 weeks

6 weeks
3 visits (1 in-person, 2 virtual for intervention group); 1 visit (in-person for Comparator A); self-directed for Comparator B

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

Extension

Long-term evaluation of CGM use and outcomes at 3 and 6 months post-intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • One-time clinic-based CGM training
  • Self-directed CGM training
  • Three-stage CGM integration program

Trial Overview

The study compares three ways to teach older adults how to use continuous glucose monitors (CGMs): a multi-session skills program (in-person and virtual), one-time clinic training, or self-directed learning with an informational pamphlet. Participants are randomly assigned to one group.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention
Group II: Comparator BActive Control1 Intervention
Group III: Comparator AActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

American Diabetes Association

Collaborator

Trials
148
Recruited
102,000+

Citations

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Decreased HbA1C · Decreased glycemic variability · Increased time in range · Decreased time in hypoglycemia · Reduction in hypoglycemic events.

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Real-time CGM showed advantages over intermittently scanned CGM for TIR (+5.63 %, P-value<0.001) and hypoglycemia reduction (−1.28 %, P-value<0.001). Automated ...

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Analyze and evaluate clinical and financial data that you have collected. Compare diabetes outcomes post-Personal CGM Program to pre-program outcomes. If ...

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Step 1 Confirm that adequate data are available . For Current CGM users, a minimum of 70% of 2 weeks of data is recommended.34 Fewer days are needed when ...

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FDA - Summary of Safety and Effectiveness Data (SSED)

The purpose of this pivotal study was to evaluate the effectiveness and safety of the G4 CGM with a modified algorithm (Software 505) when used as an ...