CGM4Home for Hypoglycemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Barnes Jewish Hospital/ Washington University, Saint Louis, MO
Hypoglycemia+5 More
CGM4Home - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a continuous glucose monitor may help improve blood glucose control and quality of life for individuals with poorly controlled diabetes.

See full description

Eligible Conditions

  • Hypoglycemia
  • Type 1 Diabetes Mellitus
  • Hypoglycemia Unawareness
  • Hyperglycemia
  • Type2 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether CGM4Home will improve 1 primary outcome and 3 secondary outcomes in patients with Hypoglycemia. Measurement will happen over the course of Baseline and 3 months.

Month 3
Mean Time in range outcomes
At 3 months
To determine the feasibility of initiating a continuous glucose monitoring in patients with diabetes at hospital discharge
At 6 months
Percentage of patients that discontinue the CGM
Baseline and 3 months
Mean change in self-efficacy at 3 months

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

CGM Intervention
1 of 1
Experimental Treatment

This trial requires 100 total participants across 1 different treatment group

This trial involves a single treatment. CGM4Home is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

CGM Intervention
Device
All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 month and 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 1 month and 3 months for reporting.

Who is running the study

Principal Investigator
P. C. B.
Prof. Paulina Cruz Bravo, Assistant Professor of Medicine
Washington University School of Medicine

Closest Location

Barnes Jewish Hospital/ Washington University - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 years of age or older
Have diabetes (type 1 diabetes mellitus, type 2 diabetes mellitus, cystic fibrosis related diabetes mellitus)
Hemoglobin A1c greater than or equal to 8.0% or history of hypoglycemia unawareness
Able and willing to sign informed consent form
Have a valid telephone number
Willing to purchase FreeStyle Libre 2 CGM sensors out of pocket after discharge from hospital (when insurance coverage isn't available)

Patient Q&A Section

What is cgm4home?

"For patients suffering hypoglycemic episodes at home, the hypoglycemia alerts set the patient's blood glucose level to a target range using three algorithms in combination with a sensor kit. In a recent study, findings show the effectiveness of this approach within the scope of real-life operation." - Anonymous Online Contributor

Unverified Answer

How many people get hypoglycemia a year in the United States?

"Between 2.31 million and 6 million people in the United States may develop hypoglycemia during the year. For example, a patient who takes 4 mg of a slow-release injectable anti-diabetic would suffer around 5,500 hypoglycemic events per year. To compare, a non-diabetics would suffer the equivalent of 713,900 hypoglycemic events per year. Overall the prevalence of hypoglycemia is not very low, especially in the United States, which makes it hard to identify potential patients." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hypoglycemia?

"Treatment for hypoglycemia is highly dependent on the cause and severity of the hypoglycemia. A physician must recognize and manage any symptomatic hypoglycemia that occurs. The treatment of mild hypoglycemia is based on the type of food that was ingested. To treat severe hypoglycemia (i.e., < 40 mg/dL), insulin and dextrose are used. A review of hypoglycemia treatment could benefit physicians looking to treat patients with hypoglycemia or if they are experiencing hypoglycemia. To benefit patients, treatments for hypoglycemia should be taught within a health-care setting." - Anonymous Online Contributor

Unverified Answer

What is hypoglycemia?

"A low blood sugar level is a condition that occurs when the body cannot digest or use enough blood sugar with food. It is characterized by symptoms such as weakness, tiredness, sweating, nausea, and dizziness. Symptoms may be triggered by exposure to low temperatures, heavy exercise, or stress. Other, less frequently reported symptoms include headache, confusion, lethargy, and irritability. Without treatment, low blood sugar levels can cause muscle twitching, seizures, or unconsciousness. Once low blood sugar occurs, treatment can be started with glucose or insulin. Most cases of hypoglycemia resolve after several hours, although treatment with insulin may be needed." - Anonymous Online Contributor

Unverified Answer

Can hypoglycemia be cured?

"Hypoglycemia can be cured but usually requires frequent adjustments to the insulin regimen. Treatment of long-standing hypoglycemia is most often achieved by means of insulin or other insulin analogues (e.g., detemir) with low frequency of recurrent hypoglycemia (e.g., < 1 hypoglycemic episodes/wk)." - Anonymous Online Contributor

Unverified Answer

What causes hypoglycemia?

"Hypoglycemia may occur from one of various causes, including improper diet and lack of physical activity. Other causes can be a side effect of certain medications like metformin. There are many factors that can lead to hypoglycemia including: insulin, glucagon secretion, exercise, ketosis, hyperinsulinemia, food composition, aging, alcohol, ketones, and stress. Diagnosis of hypoglycemia is challenging because many causes may mimic symptoms. The best practices for hypoglycemia treatment is to obtain an accurate history and physical before initiating treatment. The best management strategy for hypoglycemia is to treat symptoms, prevent recurrence, and monitor the person thoroughly afterward." - Anonymous Online Contributor

Unverified Answer

What are the signs of hypoglycemia?

"hypoglycemia often has no symptoms. Signs of hypoglycemia include decreased energy levels, dizziness and confusion. Also, individuals with hypoglycemia oftentimes will lose consciousness, suffer vomiting, diaphoresis and have seizures. Hypoglycemia can be prevented by increasing the amount of food intake daily or by consuming small meals, which is often easier to do on a smart phone, as well as increasing the amount of carbohydrates in the diet.\n" - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hypoglycemia?

"Hypoglycemia occurs in this age group and is significantly more common in younger children. This is not unusual in this age group. Parents should be aware of the need to administer emergency glucose or other treatments to their children when the child exhibits symptoms and is not taking their medications. Treatment of symptomatic children is imperative for their safety and the wellness of the family." - Anonymous Online Contributor

Unverified Answer

Does cgm4home improve quality of life for those with hypoglycemia?

"Cgm4home is well received and appears safe. However, this study suggests that it has a positive effect on quality of life and mental well-being, specifically perceived hypoglycemia symptoms." - Anonymous Online Contributor

Unverified Answer

How serious can hypoglycemia be?

"Hyperglycemia is associated with adverse outcomes and is one of the most common reasons for hospitalization in adults. Hypoglycemia is also associated with severe adverse outcomes, particularly among those most vulnerable to adverse outcomes. In the absence of a clear benefit and consideration of the complexity of care, treatment of hypoglycemia should be reserved for the most critically ill, hospitalized patients." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hypoglycemia?

"There have been very few recent studies and studies that have come out recently on hypoglycemic effects of several medications. This review of the literature will give a concise summary of the results and will also compare the current treatment of glucose, glucagon, and epinephrine to hypoglycemic drugs in the market. The reviews will also look at the effects of several oral hypoglycemic agents including glibenclamide, glimepiride, pramlintide and lixisenatide. This will help show both the efficacy and drawbacks of these hypoglycemic drugs. Some studies that should be looked at in the future include the effects of ketones on the neurological disorders and the effects of externals in hypoglycemic treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hypoglycemia?

"When assessing patients in an emergency department with hypoglycemia, it is important to consider both a clinical and basic investigation. These two steps determine how to treat the patient and prevent hypoglycemia in the future. In many cases, hypoglycemia is a result of excessive insulin intake. While in this instance, an injectable drug is necessary, the most effective option is to increase the patient's carbohydrate intake. Patients should be informed about the risks of ingesting too much insulin, not eating enough carbohydrates, or having a meal before their scheduled insulin dose. In the past there has been discussion in the lay press regarding the "low fat/low fat" debate." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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