What side effects are associated with this type of intervention?

Common treatments for diabetes include insulin therapy, continuous glucose monitoring (CGM), and medications such as DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors. Insulin therapy can cause hypoglycemia, weight gain, and injection site reactions. CGM devices may lead to skin irritation or discomfort at the sensor site. DPP-4 inhibitors are generally well-tolerated but can cause nasopharyngitis and, rarely, pancreatitis. GLP-1 receptor agonists often cause gastrointestinal side effects like nausea and vomiting. SGLT2 inhibitors can lead to urinary tract infections, genital infections, and a temporary decrease in kidney function.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetes, including continuous glucose monitoring (CGM) systems, which are essential for managing blood glucose levels in patients on complex insulin regimens. Notable CGM systems include the Dexcom G6 and the FreeStyle Libre. Additionally, GLP-1 receptor agonists such as exenatide (Bydureon BCise) and dulaglutide have been approved for improving glycemic control in type 2 diabetes. Insulin therapies, including basal and premixed insulins, are also widely used and have been approved for managing both type 1 and type 2 diabetes. These treatments, along with patient-centered models like the REST model, aim to enhance diabetes management and improve patient outcomes.

What other types of research exist?

Promising alternatives to the REST Model for diabetes patients in 2024 include: 1) Automated Closed-Loop (ACL) systems, which have shown significant improvements in A1C levels and time in range, especially for those with high baseline A1C values. 2) Bihormonal automated systems using both insulin and glucagon, which have demonstrated reduced episodes of hypoglycemia in children. 3) The use of SGLT2 inhibitors, which have shown benefits beyond glycemic control, including lower risks of graft failure and serum creatinine doubling in kidney transplant recipients with diabetes. These alternatives leverage advanced technology and pharmacotherapy to enhance diabetes management and patient outcomes.

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Device

CGM Use for Diabetes (REST Trial)

Q: What is the mechanism of action of this treatment?

Insulin therapy and continuous glucose monitoring (CGM) are common treatments for diabetes. Insulin therapy involves administering insulin to manage blood glucose levels, essential for patients with insufficient insulin production or insulin resistance. CGM systems provide real-time glucose monitoring, offering detailed insights into glucose trends and patterns. This helps patients and healthcare providers make timely adjustments to diet, exercise, and medication, improving glycemic control and reducing complications. Understanding these mechanisms empowers patients to manage their condition effectively and make informed treatment decisions.

N/A

Recruiting

Research Sponsored by Joslin Diabetes Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Insulin treatment includes: ≥3 insulin injections/day or on insulin pump therapy

T1D or T2D with duration longer than 1 year

Must not have

End-stage renal disease (eGFR< 30ml/min)

On hydroxyurea therapy due to interference with Dexcom G6 sensor readings

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months vs 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help older adults with diabetes start and keep using continuous glucose monitors through a program that includes readiness assessment, remote education, and a sustainability plan. It targets older adults who are at higher risk of low blood sugar levels.

Who is the study for?

This trial is for older adults aged 65 or above with Type 1 or Type 2 Diabetes, who are on complex insulin regimens and have not used a Continuous Glucose Monitor (CGM) before or aren't meeting their glycemic goals. Participants must be willing to wear the CGM device at all times and use a smartphone for data upload.

What is being tested?

The study tests the REST model's effectiveness in helping older adults adopt and keep using a CGM. It will also explore how this model affects quality of life and economic factors, aiming to create a sustainable framework for CGM use.

What are the potential side effects?

While specific side effects are not mentioned, wearing a CGM may cause skin irritation where it attaches, potential allergic reactions to adhesive materials, or discomfort from carrying the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I take insulin more than 3 times a day or use an insulin pump.

Select...

I have had type 1 or type 2 diabetes for over a year.

Select...

My blood sugar often drops below 70 mg/dL or stays within 70-180 mg/dL less than 40% of the time.

Select...

I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is severely reduced.

Select...

I am taking hydroxyurea which affects my Dexcom G6 sensor readings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months vs 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months vs 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months vs 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The co-primary effectiveness outcomes

The co-primary implementation outcomes

Secondary study objectives

Cost Effectivness

Cost effectivness

Diabetes health related quality of life measures

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Glucose Monitor

2021

Completed Early Phase 1

~860

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Insulin therapy and continuous glucose monitoring (CGM) are common treatments for diabetes. Insulin therapy involves administering insulin to manage blood glucose levels, essential for patients with insufficient insulin production or insulin resistance. CGM systems provide real-time glucose monitoring, offering detailed insights into glucose trends and patterns. This helps patients and healthcare providers make timely adjustments to diet, exercise, and medication, improving glycemic control and reducing complications. Understanding these mechanisms empowers patients to manage their condition effectively and make informed treatment decisions.

Development and Evaluation of a Prediabetes Decision Aid in Primary Care: Examining Patient-Reported Outcomes by Language Preference and Educational Attainment.A Systematic Review of Collective Evidences Investigating the Effect of Diabetes Monitoring Systems and Their Application in Health Care.Impact on guidelines: The general practitioner point of view.