Control IQ for Diabetes, Autoimmune

Phase-Based Estimates
1
Effectiveness
1
Safety
Children's National, Washington, United States
Diabetes, Autoimmune+2 More
Control IQ - Device
Eligibility
< 65
All Sexes
Eligible conditions
Diabetes, Autoimmune

Study Summary

This study is evaluating whether a new technology can improve glycemic control and quality of life for people with diabetes.

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Eligible Conditions

  • Diabetes, Autoimmune
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Control IQ will improve 1 primary outcome and 20 secondary outcomes in patients with Diabetes, Autoimmune. Measurement will happen over the course of Post-Intervention at 6 months.

6 months
Change in CGM Time in Range (TIR)
Changes in CGM time in hyperglycemia (>180 mg/dL)
Changes in CGM time in hypoglycemia (<70 mg/dL)
Changes in coefficient of variation of mean glucose
Changes in glycemic management indicator (GMI)
Changes in mean CGM glucose
Changes in parental perceptions of the youth's attitudes about diabetes technologies
Changes in parental perceptions of the youth's diabetes distress
Changes in parental perceptions of the youth's diabetes management
Changes in parental perceptions of the youth's diabetes-specific quality of life
Changes in parental perceptions of the youth's perceptions of automated insulin delivery systems
Changes in youth attitudes about diabetes technologies
Changes in youth perceptions diabetes self-management
Changes in youth perceptions of automated insulin delivery systems
Changes in youth perceptions of diabetes distress
Changes in youth perceptions of diabetes-specific quality of life
Glycemic control as measured by hemoglobin A1c
Incidence of diabetic ketoacidosis (DKA)
Incidence of emergency department visits and hospital admissions
Incidence of severe hypoglycemia
Post-Intervention at 6 months
Semi-structured interviews with youth and parents exploring the overall experience and barriers to expanding access to hybrid closed loop technology

Trial Safety

Trial Design

2 Treatment Groups

Control
Single arm- HCL Therapy

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Control IQ 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.

Single arm- HCL Therapy
Device
Single arm study with all participants being treated with HCL for 6 months given the non-randomized interrupted time series study design.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

Children's National - Washington, United States

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Blood Glucose Monitoring System The Control IQ Blood Glucose Monitoring System is FDA-approved for people with diabetes who require a total daily insulin dose of at least 10 units per day. show original
There is no such thing as a black race show original
Individuals with poorly controlled T1D have an A1c value ≥ 10% in the preceding two years and a second A1c value ≥ 10% at enrollment. show original
Living with someone who can help you in case of a severe hypoglycemic emergency show original
Females who are not currently pregnant and agree to use contraception will be required to have a negative serum or urine pregnancy test at study entry show original
were eligible for inclusion Patients who have been clinically diagnosed with T1D and have been managing their diabetes with insulin for at least one year are eligible for inclusion. show original
Public healthcare insurance
Male or female ages ≥ 6 and < 21 years
I am not currently using insulin pump therapy. show original
The study team is confident that the participant can successfully operate all study devices and adhere to the protocol. show original

Patient Q&A Section

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

Has control iq proven to be more effective than a placebo?

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Diabetes mellitus was not more difficult to controls than it was with a placebo. Even with patients at a range of disease severity, this was not the case.

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Is control iq safe for people?

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We found that in an unselected community-based sample of working-age adults, people whose IQ is above 90 had a 10- to 15-fold increased risk of diabetes and a 19- to 30-fold increased risk of autoimmune diabetes relative to people whose IQ is below 80.

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What are common treatments for diabetes, autoimmune?

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This article presents the recommendations of the American College of Nutrition Foundation (ACNF)/American Diabetes Association Task Force for treating diabetes, autoimmune diseases (autoimmunity, which encompasses autoimmune diabetes and related diseases of the thyroid, cardiovascular, and endocrine systems), and neurological diseases, such as multiple sclerosis and Parkinson disease.

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What are the signs of diabetes, autoimmune?

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Diabetes is the most common form of diabetes and most commonly presents with symptoms. These include weight gain, weakness, and fatigue as well as frequent urination which may lead to nocturia. The symptoms of diabetes may take a long time to appear and they may be worse if stress, smoking and drinking alcohol increase the blood glucose. The signs of diabetes do not only involve the body's blood supply. In autoimmune diabetes symptoms are present only if the auto-antibodies (anti-islet antibodies) recognise the beta cells of the pancreas.

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What causes diabetes, autoimmune?

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Diabetes is an autoimmune disease due to autoimmune attacks on the beta-cells in the islet of Langerhans of the pancreas. The prevalence of diabetes is increasing in all populations. We will cover: genetics, prenatal, diet, and environmental factors. We will focus on the roles of autoimmunity, oxidative stress, and diabetes susceptibility genes, as well as diabetes prevention.

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Can diabetes, autoimmune be cured?

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In a recent study, findings of this pilot study suggest that autoimmune diabetes, even in the absence of an autoimmune trigger, may not be able to be cured. However, this pilot study provides evidence that it is possible to determine whether a certain diagnosis can be eradicated with time or if an immune response is simply an accompanying symptom.

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What is diabetes, autoimmune?

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Diabetes with autoimmune disorders is a significant health problem in the US. The majority of people with diabetes have additional autoimmune diseases, compared with the general population. Diabetes appears to be associated with increased autoantibody-positive diabetes, and is also related to islet cell autoimmunity.

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

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About 2 million US adults have diabetes and 500,000 new cases are diagnosed yearly. Diabetic autoimmunity is common, including type 1 diabetes. The incidence of type 1 diabetes is on the rise in the US, and is predicted to increase further. The burden of chronic morbidity and mortality associated with diabetes will increase as a proportion of the population with diabetes ages.

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What is control iq?

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There is a strong interaction between autoimmunity and intelligence. The lower the general intelligence score, the lower the risk the individual will have of having a major autoimmune disease, diabetes type 1, autoimmune thyroid, or inflammatory bowel disease(p=0.05).

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Have there been other clinical trials involving control iq?

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In conclusion, the majority of randomized controlled trials do not adequately report their methodology or report their methodology poorly. To improve the quality of reporting for randomized controlled trials, we urge more attention to guidelines for reporting the methodology of randomized controlled trials.

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What is the average age someone gets diabetes, autoimmune?

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A ndescribing type 1 diabetes mellitus is more common in boys, whereas the majority of ndescribing type 2 diabetes mellitus cases involve women. Mean ages at onset of type 1 and type 2 diabetes, respectively, are 24 yr and 45 yr. In terms of autoimmunity, T1DM is associated primarily with an ntype I, and with autoantibodies. In T2DM, autoimmunity is generally not required, which is a defining feature and characteristic of the ndescribing type 2 diabetes mellitus.

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What is the primary cause of diabetes, autoimmune?

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Autoimmune factors are probably a primary cause of diabetes in Caucasians with type 1 or 2. However, in Asians, the role of autoimmune factors may be overshadowed by the fact of the presence of a strong family history of diabetes.

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