Treatment for Diabetes, Autoimmune

Phase-Based Estimates
1
Effectiveness
1
Safety
UC Davis Health, Sacramento, CA
Diabetes, Autoimmune+4 More
Eligibility
18+
All Sexes
Eligible conditions
Diabetes, Autoimmune

Study Summary

This study is evaluating whether continuous glucose monitoring may help improve blood sugar control for individuals with diabetes.

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Eligible Conditions

  • Diabetes, Autoimmune
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Insulin Dependent Diabetes
  • Transplanted Kidney Complication

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 5 secondary outcomes, and 1 other outcome in patients with Diabetes, Autoimmune. Measurement will happen over the course of up to 70 days.

70 days
Glycemic variability
Incidence of all-cause emergency room utilization and rehospitalizations
Incidence of post-transplant infections during study period
Time in Range (70-180 mg/dl)
safety endpoint Hypoglycemia
up to 70 days
Adherence to Diabetic Diet
CGM satisfaction questionnaire (10 questions)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Self monitoring of blood glucose (fingersticks)
Placebo group

This trial requires 80 total participants across 2 different 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.

Self monitoring of blood glucose (fingersticks)
Device
The control arm will remain on standard-of-care SMBG while the intervention arm will use their CGM. The control arm utilizing SMBG will be required to have at minimum 4 glucose checks per day.
Continuous glucose monitoring (CGM)
Device
Those in the intervention arm will wear a continuous glucose monitoring device. They only need to perform blood glucose fingersticks if the CGM transmission is lost for a prolonged period of time or in cases of hypo- or hyperglycemia when symptoms don't align with blood glucose readings.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 70 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 70 days for reporting.

Closest Location

UC Davis Health - Sacramento, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18 or above
/1.73m2) I received a kidney transplant less than a year ago and my kidney is still functioning well (my eGFR is more than 30 mL/min/1.73m2). show original
A person with type 2 diabetes and on insulin is someone who has diabetes and is using insulin to control their blood sugar levels show original
Access to home wi-fi connection

Patient Q&A Section

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

What are common treatments for diabetes, autoimmune?

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It is very common for diabetes patients to be treated with anti-diabetic medications, to undergo oral glucose tolerance testing, and to have a screening eye examination.

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

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The American Diabetes Association estimates approximately 90 million Americans will be diagnosed with diabetes by the age of 30 in 2025. The ADA's annual report, "Diabetes: the National Healthcare Plan" illustrates the increasing health impact of this disease.

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What is diabetes, autoimmune?

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Diabetic retinopathy is the most common sight-threatening complication in diabetes (8.3 million/yr) and appears to be related to early atherosclerosis (0.4-3.1 million/yr) and autoimmunity (0.7-1.1 million/yr) of the eye (Ozumaki C, J Pediatr Ophthalmol 21, 1165-76).

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What causes diabetes, autoimmune?

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Autoimmune and genetic factors play a role in developing diabetes, but further work is required. Diabetes mellitus is an autoimmune disease involving immunological reactions to beta adrenergic receptors.

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What are the signs of diabetes, autoimmune?

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Diagnosis of diabetes can be difficult because it is not a straightforward issue. Symptoms such as an increased frequency and severity of glycemic values are often the first signs to appear. It is also possible that patients might present with a family history of diabetes. Symptoms that indicate diabetes, autoimmune, or other diseases need to be further investigated to make a proper diagnosis.

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Can diabetes, autoimmune be cured?

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Diabetics are more likely to be diagnosed with autoimmune conditions than nondiabetics, perhaps because there's a greater awareness of autoimmune conditions among diabetics. Autoimmunity could be a marker for an increased risk for developing chronic and disabling complications. However, in older children and adults with diabetes, there is no significant difference in the incidence of autoimmune conditions, as compared with nondiabetics. So when considering immunosuppressive therapy, this factor cannot be ignored.

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Does treatment improve quality of life for those with diabetes, autoimmune?

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Significant improvements in overall HRQOL and in several aspects of HRQOL are achievable with treatment of patients with diabetes and autoimmune disorders using an evidence-based approach.

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What does treatment usually treat?

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The clinical features of each of these four conditions (i.e., thyroid disease, autoimmune thyroid disease, type 1 diabetes, and type 2 diabetes) are very similar and most importantly not very different from one another. Type 1 and type 2 diabetes in particular should be treated as variants of a unique entity based on clinical similarity rather than differences in clinical presentation. This means that treatments that are normally directed at either type 1 diabetes or type 2 diabetes may be just as effective at treating either form of the disease.

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Has treatment proven to be more effective than a placebo?

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Treatment with conventional antidiabetics and aspirin was superior to treatment with placebo. Results from a recent paper are discussed with regard to their mechanisms of action in addition to the possibility of a direct effect of the agents examined, while not excluding the possibility of a non-specific effect of the agents.

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Who should consider clinical trials for diabetes, autoimmune?

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For many new-onset autoimmune diseases, the risks and benefits of treatment are uncertain. Treatments might be considered for all patients if benefit outweighs risk, but many patients with autoimmune disease would never be eligible for treatment.

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What is the latest research for diabetes, autoimmune?

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Diabetic complications are more prevalent among those with autoimmune or inflammatory diseases than in those without them, and diabetes associated with autoimmune diseases is found more often in women.

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How serious can diabetes, autoimmune be?

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Diabetes-related autoimmunity in females is not as [severe] as in males. In females, autoimmune [type 1 diabetes](https://www.withpower.com/clinical-trials/type-1-diabetes) is rare, and [in this study] type 2 diabetes is rarer. The prevalence of diabetic retinopathy is higher in females than in males, and the percentage of diabetics getting sight loss is not so high. Thus, female diabetes patients are healthier and less likely to end up with sight loss than the male counterparts. But the seriousness of diabetes and diabetes-related autoimmunity cannot be forgotten.

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