CLINICAL TRIAL

Treatment for Diabetes Mellitus

Recruiting · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether smart insulin pens combined with continuous glucose monitoring devices can improve glucose control in patients with type 2 diabetes.

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About the trial for Diabetes Mellitus

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Point of Care Glucose Group
OTHER
Control Group 2
Smart insulin pens and CGM
DEVICE

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Insulin-treated patients with DM2 (treated with basal-bolus insulin regimens (MDI), ± non-insulin medications) and Uncontrolled glycemic control
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 7 secondary outcomes in patients with Diabetes Mellitus. Measurement will happen over the course of 6 months.

Change in hyperglycemia
6 MONTHS
Change in HbA1c
Change in Time in Range (70-180 mg/dl)
6 MONTHS
Change in CGM glucose Time in Range (70-180 mg/dl)
Change in Glucose Variability
6 MONTHS
Change in Coefficient of Variation (CV)
Change in hypoglycemia
6 MONTHS
Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min)
Change in clinically significant hypoglycemia
6 MONTHS
Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min)
Change in Time Above Range (>180 mg/dl)
6 MONTHS
Change in CGM Time Above Range (>180 mg/dl)
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Who is running the study

Principal Investigator
I. S.
Prof. Ilias Spanakis, Associate Professor of Medicine
University of Maryland, Baltimore

Patient Q & A Section

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

How many people get diabetes mellitus a year in the United States?

About 24 million Americans have diabetes at the time of the survey. They have increased about 1.3% annually since 1995. Many of those with diabetes do not have usual methods of self-monitoring blood glucose. Almost 8% of adults with diabetes and diabetes-related complications have had at least one amputation. Diabetes-associated mortality decreases with better glycemic control.

Anonymous Patient Answer

What is diabetes mellitus?

Diabetes mellitus is a common disease that contributes to excess mortality and morbidity. Rates rise with age (in men) and there are also ethnic differences. Diabetes causes complications in the kidneys, cardiovascular system, and eyes. The International Diabetes Federation currently estimates that 246 million people, 3 of whom die each day, are affected by diabetes. Prevention of this disease is a global public health objective and diabetes care programs should be introduced at schools.

Anonymous Patient Answer

What are common treatments for diabetes mellitus?

These treatments include diabetes medication, dietary/switching therapy, exercise, and smoking cessation. Diabetes medications are sometimes used to prevent future problems of the heart and blood flow, and lifestyle changes help prevent progressive damage to the vessels which helps prevent the development of atherosclerosis, or hardening of blood vessels.

Anonymous Patient Answer

What are the signs of diabetes mellitus?

The signs of DM include frequent and excessive urination, frequent and uncontrolled high blood sugar or fasting hyperglycemia, painful or swollen feet that do not go away with weight loss, and a red eye and skin lesion (eczema) without a skin rash on the hands and/or feet. Abnormal values in the blood test (e.g., elevated cholesterol level, kidney tests, or low blood pressure) also are signs of DM. In more serious cases, uncontrolled high blood sugar and ketoacidosis are signs if DM.

Anonymous Patient Answer

Can diabetes mellitus be cured?

One out of eight patients with type 1 DM can be cured by a simple, low-cost treatment containing only a single injections of insulin. This regimen might be used to control or even cure DM patients.

Anonymous Patient Answer

What causes diabetes mellitus?

Diabetes mellitus is best understood as a result of interactions among genes, environment, and the pancreas. The pancreas's alpha cells secrete the hormone, insulin, which regulates the amount of glucose in the blood. Diabetes in the young and young adults can be familial, but most cases occur later in life. Diabetes may be diagnosed with increased risk of developing coronary artery disease. Diabetes can cause coronary heart disease in the presence of hyperlipidemia. It is not known whether all forms of diabetes cause heart disease. Diabetes can also cause certain forms of kidney failure and eye problems.

Anonymous Patient Answer

Does treatment improve quality of life for those with diabetes mellitus?

Improvements in quality of life were observed despite persistence of diabetic autonomic neuropathy, suggesting that treatment of peripheral or autonomic neuropathy may improve quality of life even in persons with moderate to severe or longstanding diabetes.

Anonymous Patient Answer

What is the latest research for diabetes mellitus?

The recent research in the development of new treatments for diabetes mellitus and for its complications was very informative and informative. Further research in the area will also enhance our ability to manage diabetes mellitus and its complications.

Anonymous Patient Answer

What is the primary cause of diabetes mellitus?

Diabetes mellitus can be traced back to two major types, the intrinsic and the environmental. The intrinsic type is mostly associated with genetic mutation while the environmental causes are mostly due to diet and stress. The cause of diabetes mellitus is mostly complicated so the primary treatment is with lifestyle changes.

Anonymous Patient Answer

What is treatment?

Current treatment of diabetic polyneuropathy is not effective when compared with treatment of diabetic polyneuropathy in patients without diabetic autonomic neuropathy. When treating diabetic polyneuropathy with [palliative measures], patients who also have diabetic autonomic neuropathy have better outcomes.

Anonymous Patient Answer

What is the average age someone gets diabetes mellitus?

It is important to know the age someone has diabetes mellitus at the time the condition is diagnosed because prevention strategies like the [Dietary Changes to Incorporate a Whole-grain Low-carbohydrate Dietary Pattern(http://www.dietinfo.health-ejournal.org/2016/01/diet-calculation-diet_calculation_text_pdf.pdf)], which are associated with the prevention of diabetes and its complications, need to change based on the age of the person diagnosed with the condition.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

A combination of different agents is sometimes used, either for reasons of efficacy or convenience. These strategies may, at least partially, contribute to a higher incidence of serious adverse effects. Results from a recent paper suggest that patients with diabetes should be informed about the potential presence of this association.

Anonymous Patient Answer
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