This invention is directed to a cation-charged insulin composition that is effective in treating diabetes and lowering and stabilizing blood glucose levels when administered orally. The cation-charged insulin is acid and enzyme resistant, such that the cation-charged insulin is capable of surviving the acidic conditions of the stomach. The cation-charged insulin is capable of being absorbed through the gastrointestinal tract and stored in the liver, such that the cation-charged insulin is long lasting and pharmacokinetically similar to the insulin normally generated by the body. The invention is further directed to a method of preparing the cation-charged insulin composition, including: (1) removing any loosely bound surface ions present on an insulin molecule using a chelating agent; and (2) replacing all the loosely bound surface ions with zinc, magnesium, or calcium.

This invention is directed to a cation-charged insulin composition that is effective in treating diabetes and lowering and stabilizing blood glucose levels when administered orally. The cation-charged insulin is acid and enzyme resistant, such that the cation-charged insulin is capable of surviving the acidic conditions of the stomach. The cation-charged insulin is capable of being absorbed through the gastrointestinal tract and stored in the liver, such that the cation-charged insulin is long lasting and pharmacokinetically similar to the insulin normally generated by the body. The invention is further directed to a method of preparing the cation-charged insulin composition, including: (1) removing any loosely bound surface ions present on an insulin molecule using a chelating agent; and (2) replacing all the loosely bound surface ions with zinc, magnesium, or calcium.

Devices, systems, and techniques for controlling delivery of therapy for diabetes are described. In one example, a system includes a wearable device configured to generate user activity data associated with an arm of a user; and one or more processors configured to: identify at least one gesture indicative of utilization of an injection device for preparation of an insulin injection based on the user activity data; based on the at least one identified gesture, generate information indicative of at least one of an amount or type of insulin dosage in the insulin injection by the injection device; compare the generated information to a criteria of a proper insulin injection; and output information indicative of whether the criteria is satisfied based on the comparison.

Devices, systems, and techniques for controlling delivery of therapy for diabetes are described. In one example, a system includes a wearable device configured to generate user activity data associated with an arm of a user; and one or more processors configured to: identify at least one gesture indicative of utilization of an injection device for preparation of an insulin injection based on the user activity data; based on the at least one identified gesture, generate information indicative of at least one of an amount or type of insulin dosage in the insulin injection by the injection device; compare the generated information to a criteria of a proper insulin injection; and output information indicative of whether the criteria is satisfied based on the comparison.

Compositions and methods for oral and/or mucosal administration of a biologically active agent are provided according to aspects of the present disclosure which include: a plurality of particles, wherein each particle has an exterior surface, the exterior surface defining a particle interior, the exterior surface having at least one type of zwitterionic polymer and/or zwitterionic copolymer disposed thereon and/or extending therefrom; and a biologically active agent disposed on the exterior surface and/or in the particle interior, wherein the biologically active agent is or includes a protein, peptide, or dietary supplement. According to particular aspects, compositions and methods for oral and/or mucosal administration of an anti diabetes biological agent, such as insulin and/or an insulin analog.

Compositions and methods for oral and/or mucosal administration of a biologically active agent are provided according to aspects of the present disclosure which include: a plurality of particles, wherein each particle has an exterior surface, the exterior surface defining a particle interior, the exterior surface having at least one type of zwitterionic polymer and/or zwitterionic copolymer disposed thereon and/or extending therefrom; and a biologically active agent disposed on the exterior surface and/or in the particle interior, wherein the biologically active agent is or includes a protein, peptide, or dietary supplement. According to particular aspects, compositions and methods for oral and/or mucosal administration of an anti diabetes biological agent, such as insulin and/or an insulin analog.

Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.

Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.

The present system is directed in several embodiments to a method of administration of a therapeutic composition for protection of the brain of a subject at risk of injury leading to traumatic brain injury (TBI) and/or treatment of injury to the brain resulting from TBI. The method includes administering one or more therapeutic compositions comprising an effective amount of insulin directly to the subject patient's CNS, with no to minimal systemic exposure. Preferably, this method comprises administration of an effective amount of insulin to the upper third of a patient's nasal cavity, thereby bypassing the patient's blood-brain barrier and delivering the therapeutic composition directly to the patient's central nervous system.

The present system is directed in several embodiments to a method of administration of a therapeutic composition for protection of the brain of a subject at risk of injury leading to traumatic brain injury (TBI) and/or treatment of injury to the brain resulting from TBI. The method includes administering one or more therapeutic compositions comprising an effective amount of insulin directly to the subject patient's CNS, with no to minimal systemic exposure. Preferably, this method comprises administration of an effective amount of insulin to the upper third of a patient's nasal cavity, thereby bypassing the patient's blood-brain barrier and delivering the therapeutic composition directly to the patient's central nervous system.