METHODS AND SYSTEMS FOR TREATING DIABETES AND RELATED DISEASES AND DISORDERS
Systems, devices and methods treat target tissue to provide a therapeutic benefit to the patient. A tissue treatment device comprises a tissue treatment element constructed and arranged to treat target tissue, such as duodenal mucosa and/or submucosal tissue. Patients treated can safely eliminate or reduce their daily insulin intake.
1 . (canceled)
2 . A method of treating a medical condition of a patient, the method comprising:
selecting a patient, wherein the patient comprises a type 2 diabetes patient currently taking insulin at a first dosage level;
selecting a tissue treatment device;
performing a first treatment comprising:
treating the intestine of the patient with the treatment device; and
performing a second treatment comprising:
delivering insulin to the patient at a second dosage level, wherein the second dosage level is less than the first dosage level,
wherein the method results in a therapeutic benefit to the patient, and
wherein the therapeutic benefit provides an efficacy period of at least three months in which glycemic control is maintained.
3 . The method according to claim 2 , wherein the second dosage level comprises 0 units/day of insulin.
4 . The method according to claim 2 , wherein the second dosage level comprises at least 15 units/day of insulin less than the first dosage level.
5 . The method according to claim 2 , wherein the first dosage level comprises at least 10 units/day and/or at least 20 units/day of insulin.
6 . The method according to claim 2 , wherein the first dosage level comprises no more than 50 units/day and/or no more than 0.5 units/kg/day of insulin.
7 . The method according to claim 2 , wherein the therapeutic benefit comprises at least 12 months of glycemic control.
8 . The method according to claim 7 , wherein the glycemic control comprises the patient maintaining an HbA1C level that is no more than 0.2% and/or no more than 0.3% and/or no more than 0.4% greater than the patient's HbA1C level prior to the performing of the first treatment.
9 . The method according to claim 8 , wherein the second treatment further comprises the patient taking at least one anti-diabetic medication selected from the group consisting of: an agonist of GLP-1; an agonist of a GLP-1 analog; an antagonist of SGLT2; an antagonist of an SGLT2 analog; and combinations thereof.
10 . The method according to claim 2 , wherein the glycemic control comprises the patient maintaining an HbA1C level of no more than 8.5%.
11 . The method according to claim 2 , wherein the therapeutic benefit further comprises a weight loss of at least 5% of the patient's weight prior to the performing of the first treatment.
12 . The method according to claim 2 , wherein the first treatment comprises treating one or more tissue segments of the duodenum that are located distal to the papilla and/or distal to the ampulla of Vater.
13 . The method according to claim 12 , wherein the one or more tissue segments are located at least 0.1 cm from the ampulla of Vater.
14 . The method according to claim 13 , wherein the one or more tissue segments are located at least 0.5 cm, and/or at least 1.0 cm from the ampulla of Vater.
15 . The method according to claim 12 , wherein the one or more tissue segments comprise tissue located within 3 cm of the ampulla of Vater.
16 . The method according to claim 15 , wherein the one or more tissue segments comprise tissue located within 2 cm and/or within 1 cm of the ampulla of Vater.
17 . The method according to claim 2 , wherein the first treatment comprises treating one or more tissue segments of the duodenum with a cumulative axial length of at least 3.0 cm.
18 . The method according to claim 17 , wherein at least 50% of the surface area of the cumulative axial length is caused to necrose due to the first treatment.
19 . The method according to claim 2 , wherein the first treatment comprises ablating a minimum tissue surface area, and wherein the minimum tissue surface area ablated comprises at least 10 cm2 of a duodenal mucosal tissue surface.
20 . The method according to claim 19 , wherein the first treatment comprises delivering energy and/or a tissue-modifying agent to a first quantity of a tissue surface area.
21 . The method according to claim 2 , wherein the treatment device is configured to modify tissue of the intestine by delivering energy.
22 . The method according to claim 21 , wherein the energy delivered by the treatment device comprises electroporation energy.
23 . The method according to claim 21 , wherein the energy delivered by the treatment device first treatment comprises delivering energy selected from the group consisting of: thermal energy; electromagnetic energy; light energy; sound energy; and combinations thereof.
24 . The method according to claim 2 , wherein the patient has a fasting c-peptide greater than or equal to 0.6 ng/mL prior to performing the first treatment, and wherein the therapeutic benefit further comprises a reduction in patient fasting plasma glucose at 24 weeks after the treatment is performed.
25 . The method according to claim 24 , wherein the reduction in fasting plasma glucose is at least 26.5 mg/dL.
26 . The method according to claim 2 , wherein the treating of the intestine is performed in the post-papillary duodenum.