Wednesday, May 17, 2017

New "Smart" Diabetes Software from Medtronic Identifies Trends & Recommends Actions

http://type2diabetestreatment.net/diabetes-mellitus/new-smart-diabetes-software-from-medtronic-identifies-trends-recommends-actions-2/

Today Medtronic announces what is sure to be the first of a whole new generation of diabetes management software: its CareLink® Pro 3.0 Therapy Management Software — the first system to include algorithms capable of analyzing data from a patient"s insulin pump, continuous glucose monitoring (CGM) device, and blood glucose meter "to identify the most important patient information in one easy-to-use dashboard."

Take note that this first 3.0 version is for clinicians only, but similar programs will surely be available to patients directly very soon.

The addition of a smart "Dashboard" does away with the need for your doctor or you to manually pour over stacks of data reports to make sense of trends; it provides "a snapshot of ... key insulin delivery and glucose information on one page, ... pinpoints the exact times the patient experienced a low (hypoglycemic) or high (hyperglycemic) glucose pattern and prioritizes these patterns making it easier to identify what actions/behaviors tend to lead to these events."

(click the images for a closer look)

The part that analyzes high and low events is called the "Episode Summary," and it goes a step further by actually making therapy recommendations "so that clinicians can make the most informed treatment decisions possible."

"By reducing the amount of time it takes to interpret patient data, clinicians may have more time to spend with patients fine tuning and making adjustments to therapy and behavior," the company points out.

On top of that, Medtronic"s announcement quotes its Chief Medical Officer, Dr. Francine Kaufman, as saying: "We believe decision support is a key advancement toward developing an artificial pancreas, which will rely upon automated decisions to make adjustments to patients" therapy, and are excited to bring it to the medical community."

I"d have to agree that from the AP perspective, this is exciting. This summer I wrote a two-part series about how important it is to make our diabetes data speak to us. I stand by what I said then: "Reams of glucose data are only as useful as our ability to interpret them and to understand what to do about what we"ve learned."

I was so heartened to hear manufacturers buzzing about "data interpretation" at the annual ADA conference in June! So it"s no surprise to see that a key feature of next-gen logging software is the ability to automatically alert users to trends. In the consumer version, we hope that takes the form of simple messages ("You were running high the last 4 days between 3-5pm") and straightforward recommendations to combat problems ("Check lunchtime insulin:carb ratio; account for afternoon snack?").

Kudos to Medtronic for being the first to debut smart D-management software; there will surely be bugs to work out.

As I said in summer: It could just make all the difference in the world if our BG data records could be translated into meaningful recommendations for us, and not just weeks after the fact. Obviously, using a built-in algorithm doesn"t guarantee that the system would always suggest the right moves, but the alerts themselves would make all that stored data "come alive." Bring it on.

btw, Medtronic"s CareLink is part of its MiniMed Paradigm Revel System, the only FDA-approved integrated system combining an insulin pump with CGM.

With that whole proprietary system in mind, I must note: I hope vendors are paying equal attention to the 2nd pillar of my "real diabetes management" series: the burning need for interoperability and standardization: There ought to be a standard protocol so that all products storing diabetes data can "talk to each other," and connect to each other and to computers and Smartphones using standard data formats and standard cables.

As a PWD who struggles to juggle multiple devices, I"m just sayin" ...

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.

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FDA Adds Boxed Warning to Canagliflozin Due To Increased Leg and Foot Amputation Risk

http://type2diabetestreatment.net/diabetes-type-2/fda-adds-boxed-warning-to-canagliflozin-due-to-increased-leg-and-foot-amputation-risk/
Lauren Biscaldi, Assistant Editor May 16, 2017 FDA Adds Boxed Warning to Canagliflozin Due To Increased Leg and Foot Amputation Risk Share this content:

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Canagliflozin use is associated with increased risk of toe, foot, and leg amputations.

Data from 2 large clinical trials have confirmed that treatment of type 2 diabetes with canagliflozin (Invokana®, Invokamet®, and Invokamet XR®; Janssen Pharmaceuticals, Inc.) may lead to an increased risk of leg and foot amputations, according to a US Food and Drug Administration (FDA) Drug Safety Communication.1

The announcement — an update to a similar communication issued in May 20162 — cites data from CANVAS (Canagliflozin Cardiovascular Assessment Study; ClinicalTrials.gov identifier NCT01032629) and CANVAS-R (A Study of the Effects of Canagliflozin [JNJ-28431754] on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus; ClinicalTrials.gov identifier NCT01989754), which found that leg and foot amputations occurred “about twice as often in patients treated with canagliflozin compared to patients treated with placebo,” according to the FDA announcement.

Continue Reading Below

Over one year, amputation risk for patients in CANVAS and CANVAS-R was equivalent to 5.9 and 7.5 out of every 1000 patients treated with canagliflozin, respectively, compared with 2.8 and 4.2 out of every 1000 patients treated with placebo. The most common amputations resulting from canagliflozin therapy were of the toe and middle of the foot, although above-knee and below-knee leg amputations were also reported.

As a result, the FDA will require canagliflozin drug labels to include prominent boxed warnings describing the risk to patients.

Health care professionals and patients are advised to report adverse effects and serious issues resulting from canagliflozin use to the FDA MedWatch program

Related Articles
  • Renal Injury Warnings for Canagliflozin, Dapagliflozin Strengthened by FDA
  • FDA: Interim Trial Results Link Diabetes Drug to Potential Increased Risk for Amputations
  • Incidence of Diabetic Ketoacidosis Low With Canagliflozin in Type 2 Diabetes

Reference

  1. FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR). Silver Spring, MD: US Food and Drug Administration. https://www.fda.gov/Drugs/DrugSafety/ucm557507.htm. Published May 16, 2017. Accessed May 16, 2017.
  2. FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate. Silver Spring, MD: US Food and Drug Administration. https://www.fda.gov/Drugs/DrugSafety/ucm500965.htm. Published May 18, 2016. Accessed May 16, 2017.
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New "Smart" Diabetes Software from Medtronic Identifies Trends & Recommends Actions

http://type2diabetestreatment.net/diabetes-mellitus/new-smart-diabetes-software-from-medtronic-identifies-trends-recommends-actions-2/

Today Medtronic announces what is sure to be the first of a whole new generation of diabetes management software: its CareLink® Pro 3.0 Therapy Management Software — the first system to include algorithms capable of analyzing data from a patient"s insulin pump, continuous glucose monitoring (CGM) device, and blood glucose meter "to identify the most important patient information in one easy-to-use dashboard."

Take note that this first 3.0 version is for clinicians only, but similar programs will surely be available to patients directly very soon.

The addition of a smart "Dashboard" does away with the need for your doctor or you to manually pour over stacks of data reports to make sense of trends; it provides "a snapshot of ... key insulin delivery and glucose information on one page, ... pinpoints the exact times the patient experienced a low (hypoglycemic) or high (hyperglycemic) glucose pattern and prioritizes these patterns making it easier to identify what actions/behaviors tend to lead to these events."

(click the images for a closer look)

The part that analyzes high and low events is called the "Episode Summary," and it goes a step further by actually making therapy recommendations "so that clinicians can make the most informed treatment decisions possible."

"By reducing the amount of time it takes to interpret patient data, clinicians may have more time to spend with patients fine tuning and making adjustments to therapy and behavior," the company points out.

On top of that, Medtronic"s announcement quotes its Chief Medical Officer, Dr. Francine Kaufman, as saying: "We believe decision support is a key advancement toward developing an artificial pancreas, which will rely upon automated decisions to make adjustments to patients" therapy, and are excited to bring it to the medical community."

I"d have to agree that from the AP perspective, this is exciting. This summer I wrote a two-part series about how important it is to make our diabetes data speak to us. I stand by what I said then: "Reams of glucose data are only as useful as our ability to interpret them and to understand what to do about what we"ve learned."

I was so heartened to hear manufacturers buzzing about "data interpretation" at the annual ADA conference in June! So it"s no surprise to see that a key feature of next-gen logging software is the ability to automatically alert users to trends. In the consumer version, we hope that takes the form of simple messages ("You were running high the last 4 days between 3-5pm") and straightforward recommendations to combat problems ("Check lunchtime insulin:carb ratio; account for afternoon snack?").

Kudos to Medtronic for being the first to debut smart D-management software; there will surely be bugs to work out.

As I said in summer: It could just make all the difference in the world if our BG data records could be translated into meaningful recommendations for us, and not just weeks after the fact. Obviously, using a built-in algorithm doesn"t guarantee that the system would always suggest the right moves, but the alerts themselves would make all that stored data "come alive." Bring it on.

btw, Medtronic"s CareLink is part of its MiniMed Paradigm Revel System, the only FDA-approved integrated system combining an insulin pump with CGM.

With that whole proprietary system in mind, I must note: I hope vendors are paying equal attention to the 2nd pillar of my "real diabetes management" series: the burning need for interoperability and standardization: There ought to be a standard protocol so that all products storing diabetes data can "talk to each other," and connect to each other and to computers and Smartphones using standard data formats and standard cables.

As a PWD who struggles to juggle multiple devices, I"m just sayin" ...

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.

Type 2 Diabetes Treatment
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Original Article
#Diabetes_Mellitus
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New "Smart" Diabetes Software from Medtronic Identifies Trends & Recommends Actions

https://type2diabetestreatment.net/diabetes-mellitus/new-smart-diabetes-software-from-medtronic-identifies-trends-recommends-actions-2/

Today Medtronic announces what is sure to be the first of a whole new generation of diabetes management software: its CareLink® Pro 3.0 Therapy Management Software — the first system to include algorithms capable of analyzing data from a patient"s insulin pump, continuous glucose monitoring (CGM) device, and blood glucose meter "to identify the most important patient information in one easy-to-use dashboard."

Take note that this first 3.0 version is for clinicians only, but similar programs will surely be available to patients directly very soon.

The addition of a smart "Dashboard" does away with the need for your doctor or you to manually pour over stacks of data reports to make sense of trends; it provides "a snapshot of ... key insulin delivery and glucose information on one page, ... pinpoints the exact times the patient experienced a low (hypoglycemic) or high (hyperglycemic) glucose pattern and prioritizes these patterns making it easier to identify what actions/behaviors tend to lead to these events."

(click the images for a closer look)

The part that analyzes high and low events is called the "Episode Summary," and it goes a step further by actually making therapy recommendations "so that clinicians can make the most informed treatment decisions possible."

"By reducing the amount of time it takes to interpret patient data, clinicians may have more time to spend with patients fine tuning and making adjustments to therapy and behavior," the company points out.

On top of that, Medtronic"s announcement quotes its Chief Medical Officer, Dr. Francine Kaufman, as saying: "We believe decision support is a key advancement toward developing an artificial pancreas, which will rely upon automated decisions to make adjustments to patients" therapy, and are excited to bring it to the medical community."

I"d have to agree that from the AP perspective, this is exciting. This summer I wrote a two-part series about how important it is to make our diabetes data speak to us. I stand by what I said then: "Reams of glucose data are only as useful as our ability to interpret them and to understand what to do about what we"ve learned."

I was so heartened to hear manufacturers buzzing about "data interpretation" at the annual ADA conference in June! So it"s no surprise to see that a key feature of next-gen logging software is the ability to automatically alert users to trends. In the consumer version, we hope that takes the form of simple messages ("You were running high the last 4 days between 3-5pm") and straightforward recommendations to combat problems ("Check lunchtime insulin:carb ratio; account for afternoon snack?").

Kudos to Medtronic for being the first to debut smart D-management software; there will surely be bugs to work out.

As I said in summer: It could just make all the difference in the world if our BG data records could be translated into meaningful recommendations for us, and not just weeks after the fact. Obviously, using a built-in algorithm doesn"t guarantee that the system would always suggest the right moves, but the alerts themselves would make all that stored data "come alive." Bring it on.

btw, Medtronic"s CareLink is part of its MiniMed Paradigm Revel System, the only FDA-approved integrated system combining an insulin pump with CGM.

With that whole proprietary system in mind, I must note: I hope vendors are paying equal attention to the 2nd pillar of my "real diabetes management" series: the burning need for interoperability and standardization: There ought to be a standard protocol so that all products storing diabetes data can "talk to each other," and connect to each other and to computers and Smartphones using standard data formats and standard cables.

As a PWD who struggles to juggle multiple devices, I"m just sayin" ...

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.

Type 2 Diabetes Treatment
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Original Article
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Tuesday, May 16, 2017

New "Smart" Diabetes Software from Medtronic Identifies Trends & Recommends Actions

https://type2diabetestreatment.net/diabetes-mellitus/new-smart-diabetes-software-from-medtronic-identifies-trends-recommends-actions-2/

Today Medtronic announces what is sure to be the first of a whole new generation of diabetes management software: its CareLink® Pro 3.0 Therapy Management Software — the first system to include algorithms capable of analyzing data from a patient"s insulin pump, continuous glucose monitoring (CGM) device, and blood glucose meter "to identify the most important patient information in one easy-to-use dashboard."

Take note that this first 3.0 version is for clinicians only, but similar programs will surely be available to patients directly very soon.

The addition of a smart "Dashboard" does away with the need for your doctor or you to manually pour over stacks of data reports to make sense of trends; it provides "a snapshot of ... key insulin delivery and glucose information on one page, ... pinpoints the exact times the patient experienced a low (hypoglycemic) or high (hyperglycemic) glucose pattern and prioritizes these patterns making it easier to identify what actions/behaviors tend to lead to these events."

(click the images for a closer look)

The part that analyzes high and low events is called the "Episode Summary," and it goes a step further by actually making therapy recommendations "so that clinicians can make the most informed treatment decisions possible."

"By reducing the amount of time it takes to interpret patient data, clinicians may have more time to spend with patients fine tuning and making adjustments to therapy and behavior," the company points out.

On top of that, Medtronic"s announcement quotes its Chief Medical Officer, Dr. Francine Kaufman, as saying: "We believe decision support is a key advancement toward developing an artificial pancreas, which will rely upon automated decisions to make adjustments to patients" therapy, and are excited to bring it to the medical community."

I"d have to agree that from the AP perspective, this is exciting. This summer I wrote a two-part series about how important it is to make our diabetes data speak to us. I stand by what I said then: "Reams of glucose data are only as useful as our ability to interpret them and to understand what to do about what we"ve learned."

I was so heartened to hear manufacturers buzzing about "data interpretation" at the annual ADA conference in June! So it"s no surprise to see that a key feature of next-gen logging software is the ability to automatically alert users to trends. In the consumer version, we hope that takes the form of simple messages ("You were running high the last 4 days between 3-5pm") and straightforward recommendations to combat problems ("Check lunchtime insulin:carb ratio; account for afternoon snack?").

Kudos to Medtronic for being the first to debut smart D-management software; there will surely be bugs to work out.

As I said in summer: It could just make all the difference in the world if our BG data records could be translated into meaningful recommendations for us, and not just weeks after the fact. Obviously, using a built-in algorithm doesn"t guarantee that the system would always suggest the right moves, but the alerts themselves would make all that stored data "come alive." Bring it on.

btw, Medtronic"s CareLink is part of its MiniMed Paradigm Revel System, the only FDA-approved integrated system combining an insulin pump with CGM.

With that whole proprietary system in mind, I must note: I hope vendors are paying equal attention to the 2nd pillar of my "real diabetes management" series: the burning need for interoperability and standardization: There ought to be a standard protocol so that all products storing diabetes data can "talk to each other," and connect to each other and to computers and Smartphones using standard data formats and standard cables.

As a PWD who struggles to juggle multiple devices, I"m just sayin" ...

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.

Type 2 Diabetes Treatment
Type 2 Diabetes Diet
Diabetes Destroyer Reviews
Original Article
#Diabetes_Mellitus
#obesity_help

New "Smart" Diabetes Software from Medtronic Identifies Trends & Recommends Actions

http://type2diabetestreatment.net/diabetes-mellitus/new-smart-diabetes-software-from-medtronic-identifies-trends-recommends-actions-2/

Today Medtronic announces what is sure to be the first of a whole new generation of diabetes management software: its CareLink® Pro 3.0 Therapy Management Software — the first system to include algorithms capable of analyzing data from a patient"s insulin pump, continuous glucose monitoring (CGM) device, and blood glucose meter "to identify the most important patient information in one easy-to-use dashboard."

Take note that this first 3.0 version is for clinicians only, but similar programs will surely be available to patients directly very soon.

The addition of a smart "Dashboard" does away with the need for your doctor or you to manually pour over stacks of data reports to make sense of trends; it provides "a snapshot of ... key insulin delivery and glucose information on one page, ... pinpoints the exact times the patient experienced a low (hypoglycemic) or high (hyperglycemic) glucose pattern and prioritizes these patterns making it easier to identify what actions/behaviors tend to lead to these events."

(click the images for a closer look)

The part that analyzes high and low events is called the "Episode Summary," and it goes a step further by actually making therapy recommendations "so that clinicians can make the most informed treatment decisions possible."

"By reducing the amount of time it takes to interpret patient data, clinicians may have more time to spend with patients fine tuning and making adjustments to therapy and behavior," the company points out.

On top of that, Medtronic"s announcement quotes its Chief Medical Officer, Dr. Francine Kaufman, as saying: "We believe decision support is a key advancement toward developing an artificial pancreas, which will rely upon automated decisions to make adjustments to patients" therapy, and are excited to bring it to the medical community."

I"d have to agree that from the AP perspective, this is exciting. This summer I wrote a two-part series about how important it is to make our diabetes data speak to us. I stand by what I said then: "Reams of glucose data are only as useful as our ability to interpret them and to understand what to do about what we"ve learned."

I was so heartened to hear manufacturers buzzing about "data interpretation" at the annual ADA conference in June! So it"s no surprise to see that a key feature of next-gen logging software is the ability to automatically alert users to trends. In the consumer version, we hope that takes the form of simple messages ("You were running high the last 4 days between 3-5pm") and straightforward recommendations to combat problems ("Check lunchtime insulin:carb ratio; account for afternoon snack?").

Kudos to Medtronic for being the first to debut smart D-management software; there will surely be bugs to work out.

As I said in summer: It could just make all the difference in the world if our BG data records could be translated into meaningful recommendations for us, and not just weeks after the fact. Obviously, using a built-in algorithm doesn"t guarantee that the system would always suggest the right moves, but the alerts themselves would make all that stored data "come alive." Bring it on.

btw, Medtronic"s CareLink is part of its MiniMed Paradigm Revel System, the only FDA-approved integrated system combining an insulin pump with CGM.

With that whole proprietary system in mind, I must note: I hope vendors are paying equal attention to the 2nd pillar of my "real diabetes management" series: the burning need for interoperability and standardization: There ought to be a standard protocol so that all products storing diabetes data can "talk to each other," and connect to each other and to computers and Smartphones using standard data formats and standard cables.

As a PWD who struggles to juggle multiple devices, I"m just sayin" ...

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.

Type 2 Diabetes Treatment
Type 2 Diabetes Diet
Diabetes Destroyer Reviews
Original Article
#Diabetes_Mellitus
#obesity_help

New "Smart" Diabetes Software from Medtronic Identifies Trends & Recommends Actions

http://type2diabetestreatment.net/diabetes-mellitus/new-smart-diabetes-software-from-medtronic-identifies-trends-recommends-actions-2/

Today Medtronic announces what is sure to be the first of a whole new generation of diabetes management software: its CareLink® Pro 3.0 Therapy Management Software — the first system to include algorithms capable of analyzing data from a patient"s insulin pump, continuous glucose monitoring (CGM) device, and blood glucose meter "to identify the most important patient information in one easy-to-use dashboard."

Take note that this first 3.0 version is for clinicians only, but similar programs will surely be available to patients directly very soon.

The addition of a smart "Dashboard" does away with the need for your doctor or you to manually pour over stacks of data reports to make sense of trends; it provides "a snapshot of ... key insulin delivery and glucose information on one page, ... pinpoints the exact times the patient experienced a low (hypoglycemic) or high (hyperglycemic) glucose pattern and prioritizes these patterns making it easier to identify what actions/behaviors tend to lead to these events."

(click the images for a closer look)

The part that analyzes high and low events is called the "Episode Summary," and it goes a step further by actually making therapy recommendations "so that clinicians can make the most informed treatment decisions possible."

"By reducing the amount of time it takes to interpret patient data, clinicians may have more time to spend with patients fine tuning and making adjustments to therapy and behavior," the company points out.

On top of that, Medtronic"s announcement quotes its Chief Medical Officer, Dr. Francine Kaufman, as saying: "We believe decision support is a key advancement toward developing an artificial pancreas, which will rely upon automated decisions to make adjustments to patients" therapy, and are excited to bring it to the medical community."

I"d have to agree that from the AP perspective, this is exciting. This summer I wrote a two-part series about how important it is to make our diabetes data speak to us. I stand by what I said then: "Reams of glucose data are only as useful as our ability to interpret them and to understand what to do about what we"ve learned."

I was so heartened to hear manufacturers buzzing about "data interpretation" at the annual ADA conference in June! So it"s no surprise to see that a key feature of next-gen logging software is the ability to automatically alert users to trends. In the consumer version, we hope that takes the form of simple messages ("You were running high the last 4 days between 3-5pm") and straightforward recommendations to combat problems ("Check lunchtime insulin:carb ratio; account for afternoon snack?").

Kudos to Medtronic for being the first to debut smart D-management software; there will surely be bugs to work out.

As I said in summer: It could just make all the difference in the world if our BG data records could be translated into meaningful recommendations for us, and not just weeks after the fact. Obviously, using a built-in algorithm doesn"t guarantee that the system would always suggest the right moves, but the alerts themselves would make all that stored data "come alive." Bring it on.

btw, Medtronic"s CareLink is part of its MiniMed Paradigm Revel System, the only FDA-approved integrated system combining an insulin pump with CGM.

With that whole proprietary system in mind, I must note: I hope vendors are paying equal attention to the 2nd pillar of my "real diabetes management" series: the burning need for interoperability and standardization: There ought to be a standard protocol so that all products storing diabetes data can "talk to each other," and connect to each other and to computers and Smartphones using standard data formats and standard cables.

As a PWD who struggles to juggle multiple devices, I"m just sayin" ...

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.

Type 2 Diabetes Treatment
Type 2 Diabetes Diet
Diabetes Destroyer Reviews
Original Article
#Diabetes_Mellitus
#obesity_help