Efficacy and Safety of Frequently Modified Intensive Insulin
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of frequently modified
      intensive insulin therapy in patients with Type-2 and Type-1 diabetes mellitus.
    

Detailed description: 
      Insulin treatment is the mainstay of Type-1 diabetic management and one of the cornerstones
      in Type-2 diabetes. This treatment is based on multiple daily injections of different types
      of insulin. Patients follow their endocrinologists' directions by adhering to a set of
      recommended dosages and formulas, calculated by repeated blood glucose measurements. In order
      to maintain effective and safe management, glucose measurements are taken before meals and at
      bedtime, albeit imposing a heavy financial burden on a patient and their support system. For
      illustration, each disposable glucosemeter strip costs more than a dollar and needs to be
      replaced routinely 4 times daily, yielding an annual cost of more than $1500 per patient.
      Insulin dosages necessitate repeated adjustments to meet the patient's changing needs.
      Variations in food intake, body weight, physical activity, on going medical conditions and
      mood can impact a patient's insulin needs.

      Accordingly, at each diabetic clinic appointment, the endocrinologist reviews the patient's
      glucose measurements and insulin doses to determine whether the insulin dosage needs to be
      adjusted. Unfortunately, limited appointment availability restricts insulin dosages
      adjustments to once every several months. Furthermore, as a result of the limited time
      allotted for each patient, new dosing recommendations are based on a review of only the most
      recent measurements. This drawback may be one of the chief causes of suboptimal management,
      with merely 38% of diabetic patients able to achieve proper control and mitigate detrimental
      complications.

      Since the discovery of insulin by Frederick Grant Banting in 1921, only stringent glucose
      control by a regimen of multiple insulin injections has prevented microvascular and
      macrovascular complications in Type 1 diabetic patients. Moreover, insulin treatment amongst
      other treatment modalities has been shown to prevent microvascular and macrovascular
      complications in Type-2 diabetic patients. Incidentally, as the Type-2 diabetic epidemic
      expands, insulin treatment is becoming one of the main treatment modalities. Not taking into
      consideration availability, it has been established that more frequent patient-clinic
      interactions improve diabetic management in both Type-1 and Type-2 patients.

      In a typical 3-6 month interval appointment, the endocrinologist would measure a patient's
      hemoglobin A1c (HbA1c) to determine the quality of the last 3 months control. This value, is
      linearly correlated to mean glucose levels at that 3 months period and, therefore, can be
      predicted according to the measurements. We used anonymous records of glucose measurements to
      perform preliminary statistical analysis. Our results indicate that a patient's glucose level
      is a highly non-stationary process, with strong variations in both mean and standard
      deviation (SD) from one week to another. In many patients with excessive HbA1c, which are at
      levels that diabetic complications are likely to ensue, the endocrinologist is obligated to
      adjust the insulin dosage based on a review of the patient's most recent glucose values and
      the values of the past several weeks. Furthermore, since appointment timing is random and
      independent from the patient's measurements, random trends in glucose values may be
      identified that lead to different conclusions. For illustration, if a patient's appointment
      happens to occur when his glucose values randomly trend up, the endocrinologist may choose to
      increase insulin doses. On the other hand, if the appointment occurs at a time when the
      glucose levels trend down, he may act oppositely. The required frequency of follow-up and
      dose adjustment that yields better patient control is yet to be determined.

      Studies have shown that case management in patients with Type-2 diabetes can allow better
      control of HbA1c levels. These studies have involved using qualified medical professionals
      (ie, nurses, pharmacists, physician's assistants) as intervention methods, as well as
      providing counseling and follow-up calls to help patients with improved self-management of
      diabetes.

      This study is designed to show that weekly insulin dosage adjustments for intensive insulin
      therapy are superior to conservative, infrequent adjustments during clinical appointments in
      both Type-1 and Type-2 diabetes.
    

Intervention name(s): Intensive insulin therapy
Intervention type(s): Drug
Intervention description(s): Intensive insulin therapy
Other intervention name(s): Basal-bolus insulin therapy
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes, insulin.