The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see if reducing the dose of insulin before a meal and giving
      both pramlintide and insulin as dual wave infusions will lower the chance of low blood sugars
      after a meal. In addition, the study will look at giving pramlintide as a basal infusion (a
      very low steady dose) for several hours
    

Detailed description: 
      The Diabetes Control and Complications Trial (DCCT) showed that improving blood sugar control
      for individuals with Type 1 diabetes (T1DM) stopped or delayed the onset of long-term
      complications. As a result of the study, intensive insulin management is aimed to control
      blood sugar and glycosylated hemoglobin (3 month blood glucose average test) as near to
      normal as safely possible. However, hypoglycemia (low blood sugar) was increased three fold
      in the DCCT study and is the major limiting factor in gaining "tight" control of blood sugar
      in T1DM.

      In healthy individuals, an "after meal" blood sugar level is very carefully controlled.
      Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar)
      play a key role in maintaining this careful balance. In T1DM, there is a lack of insulin and
      failure of glucagon suppression (keeping glucagon from being made too much). This leads to
      hyperglycemia (high blood sugar) right after you eat food. Also, glucagon is not controlled
      correctly after a meal. The glucagon, normally produced by the body, does not increase when a
      person with T1DM has a low blood sugar. This interferes with the balance between how much
      glucose is made and how much glucose is used. Therefore, glucagon fails to protect against
      low blood sugar in people with T1DM. This makes it very difficult to have normal blood sugars
      when someone has T1DM. This imbalance may be due to another hormone called amylin. This
      hormone may be too low in people with T1DM.

      Amylin is produced in the pancreas (the part of the body that makes insulin) by the same
      cells that produce insulin and is also lacking in persons with T1DM. Amylin works by lowering
      glucagon after a meal. This keeps the liver from letting out stored sugar into the blood
      stream right after we eat. Pramlintide is man-made amylin and is given as a subcutaneous shot
      (under the skin) similar to insulin. At present, pramlintide has not received FDA approval.

      Studies performed in adults have shown that adding amylin in T1DM, using pramlintide, lowers
      the high levels of glucagon made after a meal. This results in improved "after meal" high
      blood sugars and overall blood sugar control. Currently, pramlintide in adults is given as a
      separate injection from insulin, before meals, three times a day. When given as a bolus shot
      (one dose shot given all at once) to children and young adults, it seems to cause immediate
      low blood sugars after a meal. The low blood sugars may be caused by the "slowing down" of
      food digestion by pramlintide. Another possible cause of the low blood sugars may be the way
      pramlintide is being given (bolus shot versus a dual wave infusion).
    

Intervention name(s): Pramlintide
Intervention type(s): Drug
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; hypoglycemia; hyperglycemia