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Related Concept Videos

Diabetes: Management and Pharmacotherapy01:15

Diabetes: Management and Pharmacotherapy

The therapy for diabetes aims to alleviate hyperglycemia-related symptoms, prevent acute metabolic decompensation, and reduce chronic end-organ complications. Glycemic control is evaluated through short-term (self-monitoring, continuous glucose monitoring) and long-term (A1c, fructosamine) metrics, enabling near real-time tracking of blood glucose levels and reflecting glycemic control over specific time frames.
Insulin remains the cornerstone of treatment for most patients with type 1 and many...
Type II Diabetes Mellitus III: Clinical Manifestations and Diagnosis01:25

Type II Diabetes Mellitus III: Clinical Manifestations and Diagnosis

Type 2 diabetes mellitus develops gradually and is often asymptomatic in early stages.Clinical ManifestationsWhen symptoms appear, they include fatigue, blurred vision, pruritus, delayed wound healing, and recurrent infections, particularly candidal infections. Peripheral neuropathy may present as numbness or tingling in the extremities. Classic hyperglycemia symptoms—polyuria, polydipsia, and polyphagia—are less common. Most patients are overweight and frequently have associated hypertension...
Type I Diabetes III: Clinical Manifestations01:19

Type I Diabetes III: Clinical Manifestations

Type 1 diabetes mellitus typically presents with rapid-onset symptoms due to the body’s inability to utilize glucose in the absence of insulin. Since insulin is required for glucose uptake into cells, its deficiency leads to hyperglycemia and cellular energy deprivation, resulting in characteristic clinical features.Polyuria and PolydipsiaOne of the earliest, most prominent symptoms is polyuria (excessive urination). When blood glucose concentrations rise above the renal threshold, the kidneys...
Diabetes: Symptoms, Diagnosis, and Complications01:15

Diabetes: Symptoms, Diagnosis, and Complications

For most patients, experiencing several weeks of polyuria, polydipsia, fatigue, and significant weight loss may indicate the presence of diabetes. Furthermore, adults displaying the phenotypic appearance of type 2 diabetes (particularly those who are obese and not initially insulin-requiring), may have islet cell autoantibodies, suggesting autoimmune-mediated β cell destruction and a diagnosis of latent autoimmune diabetes of adults (LADA). The categorization of glucose homeostasis is based on...
Diabetes Mellitus: Type 2 and Gestational01:22

Diabetes Mellitus: Type 2 and Gestational

Type 2 diabetes, characterized by insulin resistance, arises when the insulin receptors on cells lose responsiveness to insulin, diminishing the cell's capacity to take up glucose, resulting in elevated blood glucose levels. To receive a diagnosis of Type 2 diabetes, a series of blood glucose tests are necessary to assess whether the blood glucose falls within normal parameters. If the result is out of the normal range, a patient may be diagnosed as prediabetic or diabetic, depending on the...
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Diabetes Mellitus: Overview and Type I Subtype

Diabetes mellitus is a chronic metabolic disorder characterized by high blood glucose levels due to inadequate insulin production, insulin resistance, or both. The condition affects millions worldwide and can significantly impact their health and quality of life.
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Related Experiment Videos

Patient-important outcomes in registered diabetes trials.

Gunjan Y Gandhi1, M Hassan Murad, Akira Fujiyoshi

  • 1Division of Endocrinology, Diabetes, Metabolism and Nutrition, College of Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA.

JAMA
|June 5, 2008
PubMed
Summary

Most diabetes clinical trials do not prioritize patient-important outcomes. Only 18% of registered randomized clinical trials (RCTs) used patient-important outcomes as their primary focus, impacting safety and efficacy assessments.

Related Experiment Videos

Area of Science:

  • Clinical research methodology
  • Diabetes mellitus interventions
  • Patient-centered outcomes research

Background:

  • Concerns persist regarding the safety and efficacy of diabetes interventions.
  • Randomized clinical trials (RCTs) often lack measurement of patient-important outcomes like mortality and quality of life.

Purpose of the Study:

  • To systematically assess the inclusion of patient-important outcomes in ongoing and future diabetes RCTs.
  • To determine the proportion of diabetes RCTs that measure patient-important outcomes.

Main Methods:

  • Searched major RCT registries (ClinicalTrials.gov, ISRCTN, ANZCTR) for eligible trials.
  • Identified and sampled 436 phase 2-4 RCTs enrolling patients with diabetes, with a focus on those registered since 2004.
  • Independent reviewers extracted data on study characteristics and outcome types (patient-important, surrogate, physiological).

Main Results:

  • Only 18% of the 436 analyzed RCTs used patient-important outcomes as primary outcomes.
  • Surrogate outcomes were primary in 61% of trials, while physiological outcomes were primary in 16%.
  • Patient-important outcomes were reported as primary or secondary in 46% of trials. Larger, longer trials were more likely to include them, while parallel-design and type 2 diabetes trials were less likely.

Conclusions:

  • A significant majority of registered diabetes RCTs do not prioritize patient-important outcomes.
  • This underrepresentation may limit the assessment of true intervention effectiveness and patient well-being.
  • Future research and trial design should emphasize the inclusion of patient-important outcomes.