Treatment for Diabetes, Autoimmune

Phase-Based Estimates
1
Effectiveness
1
Safety
Institut de recherches cliniques de Montréal, Montreal, Canada
Diabetes, Autoimmune+4 More
Eligibility
18+
All Sexes
Eligible conditions
Diabetes, Autoimmune

Study Summary

This study is evaluating whether a set of activities can improve sleep habits in people with dementia.

See full description

Eligible Conditions

  • Diabetes, Autoimmune
  • Diabetes Mellitus, Type 1
  • Unconsciousness
  • Hypoglycemia
  • Hypoglycemia Unawareness
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 17 secondary outcomes in patients with Diabetes, Autoimmune. Measurement will happen over the course of 12 weeks.

12 weeks
Change in physical activity practice
Change in the Clarke score
Change in the Gold score
Change in the score of the BAPAD questionnaire
Change in the score of the Edinburgh Hypoglycemia Symptom Scale
Change in the score of the Hypoglycemia Fear Survey II
Change in treatment satisfaction
Change in well-being
Coefficient of variation of glucose levels
Number of hypoglycemic events
Number of severe hypoglycemia
Number of treated hypoglycemic events
Percentage of participants who no longer have impaired awareness of hypoglycemia
Percentage of time of glucose levels spent < 3.0 mmol/L
Percentage of time of glucose levels spent < 4.0 mmol/L
Percentage of time of glucose levels spent > 10.0 mmol/L
Percentage of time of glucose levels spent between 3.9-10.0 mmol/L
Standard deviation of glucose levels

Trial Safety

Trial Design

2 Treatment Groups

Standard educational program combined with high intensity interval training

This trial requires 62 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. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Standard educational program combined with high intensity interval trainingParticipants will be closely followed by a team of diabetes specialists. Participants will attend two education sessions to discuss the following topics: avoidance of hypoglycemia, causes of hypoglycemia, treatment (e.g. glucagon) of hypoglycemia, how to better recognize hypoglycemia symptoms, understand how to use a continuous glucose monitor (CGM) and understand CGM reports to adjust insulin doses. Each study participant will be asked to train 3 times per week following the home-based program that will be provided to them. Participants will be asked to perform at least 2 training sessions per week with the exercise specialist on a virtual platform. The training session will consist of a 3 to 5-minute low-intensity warm-up followed by 6 to 12 1-minute bouts of high-intensity exercise interspersed with 1-minute bouts of low-intensity exercise. Each session will end with a 3-minutes cool-down period.
Standard educational programParticipants will be closely followed by a team of diabetes specialists. Participants will attend two education sessions to discuss the following topics: avoidance of hypoglycemia, causes of hypoglycemia, treatment (e.g. glucagon) of hypoglycemia, how to better recognize hypoglycemia symptoms, understand how to use a continuous glucose monitor (CGM) and understand CGM reports to adjust insulin doses.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks for reporting.

Who is running the study

Principal Investigator
R. R.
Prof. Rémi Rabasa-Lhoret, Full professor
Institut de Recherches Cliniques de Montreal

Closest Location

Institut de recherches cliniques de Montréal - Montreal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients will be treated with insulin injections or a pump, and will use an insulin analog show original
The patient has impaired awareness of hypoglycemia, meaning that they are not able to sense when their blood sugar level is getting too low show original
A person who is willing to start using a continuous glucose monitor for the study. show original
Possessing an electronic device that supports the Polar Beat application, which is used to monitor heart rate. show original
People aged between 18 and 65 years old, both male and female. show original
The individual has had type 1 diabetes for at least five years. show original
HbA1c ≤ 10%

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 is diabetes, autoimmune?

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Diabetes, autoimmune is the third leading cause of death and disabling condition in Europe and the United States. Diabetes is also an important risk factor for the development of atherosclerosis, cardiovascular diseases and nephropathy. Diabetes, autoimmune should be seen as a multifactorial disease that includes both genetic and infectious elements.

Unverified Answer

What causes diabetes, autoimmune?

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Diabetes is caused by a number of factors. Autoimmunity is involved in [type 1 diabetes](https://www.withpower.com/clinical-trials/type-1-diabetes), and some risk factors associated with autoimmune disease may be involved in type 2 diabetes. Some factors, such as diet, have stronger effects on type 2 diabetes risk than type 1 diabetes risk.

Unverified Answer

What are the signs of diabetes, autoimmune?

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Many risk factors for diabetes, including type 2 diabetes, obesity and Cushing's syndrome are associated with markers of autoimmune disease. There is a growing consensus in the literature that some patients with autoimmune diseases are suffering from concurrent diabetes. This is a novel finding that demonstrates the need for a clinical approach that specifically emphasizes the screening and management of autoimmune disease concurrent with the diagnosis and management of diabetes. (H. Lee and D. Lee, 2006-2008; http://www.aadt.org).

Unverified Answer

What are common treatments for diabetes, autoimmune?

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Type 2 Diabetes does not typically cause autoimmunity. However, patients diagnosed with autoimmune diabetes are much more likely to be diagnosed with another autoimmune condition. When comparing therapies, thiazolidinediones are the most effective, followed by insulin. Other treatments include metformin.

Unverified Answer

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

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In 2015 an estimated 18.5 million people in the United States were diagnosed with a new manifestation of autoimmune disease. An estimated 1.4 million people per year were diagnosed with insulin-dependent or insulin-dependent Type 2 diabetes. An additional 7.5 million per year had a new diagnosis of some manifestation of autoimmune disease. The greatest increased risk of developing these disorders was in the 35-50 year age group, but at a rate more than two-fold that of the 30-50 year age group.

Unverified Answer

Can diabetes, autoimmune be cured?

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The disease of diabetes, autoimmune is a chronic problem which can be cured. If the [immune system functions normally and its body defends against viruses and toxins in an effective way, it can be cured. Treatment of diabetes, autoimmune begins with a careful diet, dietary supplements, and medication to support auto-immune-defenses. When the autoimmune processes [that the [immune system should support and protect itself against cancer cells] work in a way [to get rid of cancer cells], cancer of [different types from any part of the body may be cured.

Unverified Answer

Have there been any new discoveries for treating diabetes, autoimmune?

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It is crucial to find new discoveries in the area of diabetes, AIA, and treat it. You can find out about any diabetes clinical trials by using [Power (http://www.withpower.com/clinical-trials/diabetes_autimune_crd)] which gives results such as study location, condition, and treatment plan.

Unverified Answer

What does treatment usually treat?

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Diabetes does not have good treatments in remission to achieve and maintain a healthy weight for long-term health, and this seems to be a significant reason for the lack of success for the treatment of diabetes. People with moderate to severe diabetic neuropathies were most likely to have a good outcome of treatment if they had a healthy weight.

Unverified Answer

What is the average age someone gets diabetes, autoimmune?

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Overall, there has been an increase in the average age of diagnosis of diabetes and autoimmune diabetes in adults, especially men. This increase in average age of diagnosis occurs especially following pregnancy.

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Have there been other clinical trials involving treatment?

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A review of previous clinical investigations involving ovarian cancer and diabetes did uncover two prior trials of ovarian cancer and diabetes. Data from a recent study suggests a relationship between ovarian tumors and diabetes.

Unverified Answer

Has treatment proven to be more effective than a placebo?

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In clinical trials involving insulin alone and insulin plus glucocorticoids, the treatment group did not differ from a placebo group in clinical outcomes. In the absence of clinical outcomes, the use of oral antidiabetes drugs alone or in combination with other medications is probably ineffective for the maintenance of glycaemic indexes. The use of oral antidiabetes drugs is unlikely to be clinically useful in the treatment of DM1.

Unverified Answer

Does diabetes, autoimmune run in families?

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Diabetes, autoimmune run in families. answer: As demonstrated in this single-center series, diabetes is more common in autoimmunity-positive diabetic FDRs compared with FDRs with diabetes without autoimmunity. This may reflect an increased autoimmune risk in diabetic FDRs. Screening and treatment of diabetes in at-risk FDRs requires consideration of this potential increased risk of diabetes in relation to diabetes and autoimmunity.

Unverified Answer
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