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HYBRID CLOSED LOOP
INSULIN DELIVERY
SYSTEM.
Prsented BY- Shubham M. Bhujbal
F.M.Pharm (MQA Dept)
Guided By- DR. D.D.Gaikwad Sir
Dr. S.L Jadhav sir
 Introduction
 Diabetes Mellitus.
 Insulin
 History Of Insulin Pump.
 Components Of Insulin Pump.
 Using An Insulin Pump.
 How It Works...?
 Advantages
 Disadvantages
 Plan
 The Research Aspect
 References.
WHAT IS HYBRID CLOSED LOOP INSULIN
DELIVERY SYSTEM.....?
 The Hybrid closed loop insulin delivery system is a
technology in development to help people
with Diabetis, primarily type 1, automatically and
continuously control their blood glucose level by
providing the substitute endocrine functionality of a
healthy pancreas.
 It also known as ARTIFICIAL PANCREAS.
 The Hybrid Closed-Loop System: When in auto
mode, this is a hybrid closed-loop insulin
delivery system that automatically adjusts basal
insulin delivery every 5 min based on sensor
glucose to maintain blood glucose levels
as close to a specific target as possible.
DIABETES MELLITUS
 is a chronic disorder of carbohydrate,
protein, and fat metabolism resulting from
insulin deficiency or abnormality in the use
of insulin.
 is a group of metabolic disorders in which
there are high blood sugar levels over a
prolonged period. Symptoms of high blood
sugar include frequent urination, increased
thirst, and increased hunger.
TYPES OF DIABETES MELLITUS
 1.Type I-
 formerly known as Insulin – Dependent
Diabetes Mellitus (IDDM) .
 destruction of beta cells of the pancreas little
or no insulin production
 Autoimmune (Islet cell antibodies)
-Early introduction of cow’s milk and cereals.
-Intake of medicine during pregnancy
-Indoor smoking of family members.
 requires daily insulin administration.
 may occur at any age, usually appears below
age 15.
 2. Type II-
 formerly known as Non Insulin– Dependent
Diabetes Mellitus (NIDDM)
 probably caused by-
 disturbance in insulin reception in the cells
 ↓ number of insulin receptors
 loss of beta cell responsiveness to glucose
leading to slow or ↓ insulin release by the
pancreas
 occurs over age 40 but can occur in
children
 common in overweight or obese .
PANCREAS HORMONES:
INSULIN BY BETA CELLS
 GLUCAGON BY ALPHA
CELLS
 Pancreas secretes 40-50 units of insulin daily in two
steps:
 – Secreted at low levels during fasting ( basal
insulin secretion)
 – Increased levels after eating (prandial)
 An early burst of insulin occurs within 10 minutes of
eating .
 Then proceeds with increasing release as long as
hyperglycemia is present.
INSULIN
 Insulin allows glucose to move into cells to make
energy.
 Inhibits glucagon activity.
 Normal blood glucose level-
 A fasting blood sugar level less than 100
mg/dL (5.6 mmol/L) is normal.
 A fasting blood sugar level from 100 to 125
mg/dL (5.6 to 6.9 mmol/L) is considered
prediabetes.
 If it's 126 mg/dL (7 mmol/L) or higher on two
separate tests, you have diabetes.
PRE-DIABETES
Impaired fasting glucose (IFG) – FPG-
100-125mg/dL
 Impaired glucose tolerance (IGT) –
OGTT 140-199mg/dL
 HbA1c 5.7-6.4%
WHAT IS HBA1C?
 The term HbA1crefers to
glycated haemoglobin. It develops when
haemoglobin, a protein within red blood
cells that carries oxygen throughout your
body, joins with glucose in the blood,
becoming 'glycated'.
 By measuring glycated haemoglobin
(HbA1c), clinicians are able to get an overall
picture of what our average blood sugar
levels have been over a period of
weeks/months.
HISTORY OF THE INSULIN
PUMP
• The first insulin pump was developed in 1963 by
Dr. Arnold Kadish
• 1976 Dean Kamen invented the first wearable
insulin pump
• 1980’s insulin pumps start to enter the market
• Minimed and Disetronic
• MiniMed 502 first popular insulin pump
• 2003 MiniMed 512 first insulin pump to monitor
glucose levels
USING AN INSULIN PUMP
• Insert needle anywhere
into body typically the
abdomen
• Three programmable
ways to deliver insulin
• Basal rates
• Bolus doses
• Correctional doses
• Then press ok
COMPONENTS OF INSULIN PUMP-
20
THREE PARTS TO ALL CGMS:*
A. Sensor
B. Transmitter
C. Receiver/Monitor
21
A)Sensor
(p.103)
22
B)Transmitter
(p.103)
23
C)Receiver or Monitor
(p.103)
CUSTOMIZEABLE BASAL RATES
INSULIN DELIVERY MODES
INSULIN PUMPS
SENSOR CONVERTS GLUCOSE TO
ELECTRONIC SIGNALS-
HYBRID CLOSED LOOP IN TYPE 1 DIABETES -
 The clinical trial is testing Medtronic’s 670G
“hybrid-closed loop” system (insulin pump +
Enlite 3 CGM sensor) in people with type 1
diabetes.
 Based on the Enlite 3 CGM reading every
five minutes, the 670G pump’s software
automatically increases/decreases insulin
delivery to target a blood glucose of 120
mg/dl.
 The 670G algorithm is fully integrated within
the pump itself, so a patient only needs to
wear the Enlite 3 CGM sensor and the
MiniMed 670G pump – no need to carry a
separate CGM receiver.
 The 670G is considered a “hybrid-closed
loop” because the user still needs to bolus
for meals and notify the system of exercise.
 Otherwise, it mostly takes care of insulin
dosing in the background, which is very
effective at night (80%+ time-in-range in one
study we’ve seen
ADVANTAGES/ WHY THIS SYSTEM....?
 Eliminates individual insulin injections
 Deliver insulin more accurately and regularly
 Allows for exercise without having to eat a lot of
carbohydrates.
 Makes diabetes management easier
 Better control.
 Allows for lifestyle flexibility
 Eating schedule and food choices
 Activity
 Increased security from alarms & alerts
 Immediate feedback - look and learn
 BG trend provides more information than
static readings.
 Control + safety.
 Can reduce Hba1c and glycemic variability
 No need to strictly follow the diet.
 288 Data points per Day.
DISADVANTAGES
o Can cause weight gain
o Needle can fail out leading to deliver
insulin properly.
o Expensive.
o Requires training.
o Constantly need to be attached to
pump.
PLAN
 A pilot of 10 patients begins examined in
December 2018.
 About 100 patients will be enrolled during the
first year.
 All electronic data will be collected and analyzed.
 Subjects will fill specific questionnaires to assess
patient reported outcomes, quality of life and
satisfaction.
THE RESEARCH ASPECTS-
 Creating a database of all patients joining the
virtual clinic.
 Measuring the effects of virtual care on:
 Metabolic outcomes: HbA1c, ‘time in range’, rate of
hypoglycemia, etc.
 Patient reported outcomes and quality of life
 Patient satisfaction
 Outcome measures will be collected at baseline,
3 and 12 months of the intervention.
PATIENT-CENTERED CARE
Ask the patient:
What is important to
you?
What are your
goals? Health and
life goals?
Identify and respect:
Differences
Values
Preferences
Expressed needs
Decision making
must be mutually
attained
Patients MUST be
listened to and not
dictated to
Patient has a say in
care plan
Patient chooses
therapy and device
after being presented
all options
REFERENCE-
• Jerreat, Lynne. Diabetes for Nurses. London: Whurr, 1999. Print.
• IOH Diabetes Treatment - Insulin Delivery Devices." Diabetes Assistance -
Assistance Programs for Diabetes, Diabetes Laws, Insurance Laws. 11 Mar.
2006. Web. 24 Feb. 2011.
<http://www.isletsofhope.com/diabetes/treatment/insulin_devices_1.html>.
• Sattley, Melissa. "The History of Diabetes - Diabetes Health." Diabetes
Health - Investigate, Inform, Inspire. 17 Dec. 2008. Web. 24 Feb. 2011.
<http://www.diabeteshealth.com/read/2008/12/17/715/the-history-of-
diabetes/>.
• Richard. "History Of Insulin Pumps." Diabetes | Type 1 Diabetes | Type 2
Diabetes. 17 Apr. 2008. Web. 24 Feb. 2011. <http://www.dlife.com/diabetes-
forum/viewtopic.php?f=22&t=10964&start=0&sid=46065bf7bcb0a2ec5f38f0
a3b95ed542&view=print>.
• MiniMed. "Minimed ® Paradigm Revel ™ Insulin Pump MMDMMT523B."
Medical Supplies - Discount Home Medical Supply & Equipment Store.
Web. 24 Feb. 2011.
<http://www.onlinemedicalsupply.com/DIABETIC/INSULIN_PRODUCTS/M
MDMMT523B/product.aspx>.
• Noida. "Global Insulin Pumps Market Set for Stupendous Upsurge by 2015."
Press Release Distribution, Public Relations Services | SBWire. 16 Feb.
2011. Web. 24 Feb. 2011. <http://www.sbwire.com/press-releases/sbwire-
79053.htm>.
• Reuters. "Artificial Pancreas Shows Promise in Pregnancy| Reuters."
Business & Financial News, Breaking US & International News |
Reuters.com. Reuters, 30 Jan. 2011. Web. 24 Feb. 2011.
<http://www.reuters.com/article/2011/01/31/us-pancreas-diabetes-
idUSTRE70U00N20110131>.
• American Diabetes Association. "How Do Insulin Pumps Work?" American
Diabetes Association Home Page - American Diabetes Association. Web.
24 Feb. 2011. <http://www.diabetes.org/living-with-diabetes/treatment-and-
care/medication/insulin/insulin-pumps-how-do-insulin.html>.
• www.slideshar.com
• www.youtube.com
• www.google.com
ANY
QUESTIONS.....?
Thank You

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Hybrid closed loop insulin delivery system-Artificial Pancreas.

  • 1. HYBRID CLOSED LOOP INSULIN DELIVERY SYSTEM. Prsented BY- Shubham M. Bhujbal F.M.Pharm (MQA Dept) Guided By- DR. D.D.Gaikwad Sir Dr. S.L Jadhav sir
  • 2.  Introduction  Diabetes Mellitus.  Insulin  History Of Insulin Pump.  Components Of Insulin Pump.  Using An Insulin Pump.  How It Works...?  Advantages  Disadvantages  Plan  The Research Aspect  References.
  • 3. WHAT IS HYBRID CLOSED LOOP INSULIN DELIVERY SYSTEM.....?  The Hybrid closed loop insulin delivery system is a technology in development to help people with Diabetis, primarily type 1, automatically and continuously control their blood glucose level by providing the substitute endocrine functionality of a healthy pancreas.  It also known as ARTIFICIAL PANCREAS.  The Hybrid Closed-Loop System: When in auto mode, this is a hybrid closed-loop insulin delivery system that automatically adjusts basal insulin delivery every 5 min based on sensor glucose to maintain blood glucose levels as close to a specific target as possible.
  • 4.
  • 5. DIABETES MELLITUS  is a chronic disorder of carbohydrate, protein, and fat metabolism resulting from insulin deficiency or abnormality in the use of insulin.  is a group of metabolic disorders in which there are high blood sugar levels over a prolonged period. Symptoms of high blood sugar include frequent urination, increased thirst, and increased hunger.
  • 6. TYPES OF DIABETES MELLITUS  1.Type I-  formerly known as Insulin – Dependent Diabetes Mellitus (IDDM) .  destruction of beta cells of the pancreas little or no insulin production  Autoimmune (Islet cell antibodies) -Early introduction of cow’s milk and cereals. -Intake of medicine during pregnancy -Indoor smoking of family members.  requires daily insulin administration.  may occur at any age, usually appears below age 15.
  • 7.  2. Type II-  formerly known as Non Insulin– Dependent Diabetes Mellitus (NIDDM)  probably caused by-  disturbance in insulin reception in the cells  ↓ number of insulin receptors  loss of beta cell responsiveness to glucose leading to slow or ↓ insulin release by the pancreas  occurs over age 40 but can occur in children  common in overweight or obese .
  • 8. PANCREAS HORMONES: INSULIN BY BETA CELLS  GLUCAGON BY ALPHA CELLS
  • 9.  Pancreas secretes 40-50 units of insulin daily in two steps:  – Secreted at low levels during fasting ( basal insulin secretion)  – Increased levels after eating (prandial)  An early burst of insulin occurs within 10 minutes of eating .  Then proceeds with increasing release as long as hyperglycemia is present.
  • 10. INSULIN  Insulin allows glucose to move into cells to make energy.  Inhibits glucagon activity.  Normal blood glucose level-  A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is normal.  A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.  If it's 126 mg/dL (7 mmol/L) or higher on two separate tests, you have diabetes.
  • 11. PRE-DIABETES Impaired fasting glucose (IFG) – FPG- 100-125mg/dL  Impaired glucose tolerance (IGT) – OGTT 140-199mg/dL  HbA1c 5.7-6.4%
  • 12. WHAT IS HBA1C?  The term HbA1crefers to glycated haemoglobin. It develops when haemoglobin, a protein within red blood cells that carries oxygen throughout your body, joins with glucose in the blood, becoming 'glycated'.  By measuring glycated haemoglobin (HbA1c), clinicians are able to get an overall picture of what our average blood sugar levels have been over a period of weeks/months.
  • 13. HISTORY OF THE INSULIN PUMP • The first insulin pump was developed in 1963 by Dr. Arnold Kadish • 1976 Dean Kamen invented the first wearable insulin pump • 1980’s insulin pumps start to enter the market • Minimed and Disetronic • MiniMed 502 first popular insulin pump • 2003 MiniMed 512 first insulin pump to monitor glucose levels
  • 14.
  • 15. USING AN INSULIN PUMP • Insert needle anywhere into body typically the abdomen • Three programmable ways to deliver insulin • Basal rates • Bolus doses • Correctional doses • Then press ok
  • 16.
  • 17.
  • 18.
  • 20. 20 THREE PARTS TO ALL CGMS:* A. Sensor B. Transmitter C. Receiver/Monitor
  • 26. SENSOR CONVERTS GLUCOSE TO ELECTRONIC SIGNALS-
  • 27. HYBRID CLOSED LOOP IN TYPE 1 DIABETES -  The clinical trial is testing Medtronic’s 670G “hybrid-closed loop” system (insulin pump + Enlite 3 CGM sensor) in people with type 1 diabetes.  Based on the Enlite 3 CGM reading every five minutes, the 670G pump’s software automatically increases/decreases insulin delivery to target a blood glucose of 120 mg/dl.  The 670G algorithm is fully integrated within the pump itself, so a patient only needs to wear the Enlite 3 CGM sensor and the MiniMed 670G pump – no need to carry a separate CGM receiver.  The 670G is considered a “hybrid-closed loop” because the user still needs to bolus for meals and notify the system of exercise.  Otherwise, it mostly takes care of insulin dosing in the background, which is very effective at night (80%+ time-in-range in one study we’ve seen
  • 28.
  • 29. ADVANTAGES/ WHY THIS SYSTEM....?  Eliminates individual insulin injections  Deliver insulin more accurately and regularly  Allows for exercise without having to eat a lot of carbohydrates.  Makes diabetes management easier  Better control.  Allows for lifestyle flexibility  Eating schedule and food choices  Activity
  • 30.  Increased security from alarms & alerts  Immediate feedback - look and learn  BG trend provides more information than static readings.  Control + safety.  Can reduce Hba1c and glycemic variability  No need to strictly follow the diet.
  • 31.  288 Data points per Day.
  • 32.
  • 33. DISADVANTAGES o Can cause weight gain o Needle can fail out leading to deliver insulin properly. o Expensive. o Requires training. o Constantly need to be attached to pump.
  • 34. PLAN  A pilot of 10 patients begins examined in December 2018.  About 100 patients will be enrolled during the first year.  All electronic data will be collected and analyzed.  Subjects will fill specific questionnaires to assess patient reported outcomes, quality of life and satisfaction.
  • 35. THE RESEARCH ASPECTS-  Creating a database of all patients joining the virtual clinic.  Measuring the effects of virtual care on:  Metabolic outcomes: HbA1c, ‘time in range’, rate of hypoglycemia, etc.  Patient reported outcomes and quality of life  Patient satisfaction  Outcome measures will be collected at baseline, 3 and 12 months of the intervention.
  • 36. PATIENT-CENTERED CARE Ask the patient: What is important to you? What are your goals? Health and life goals? Identify and respect: Differences Values Preferences Expressed needs Decision making must be mutually attained Patients MUST be listened to and not dictated to Patient has a say in care plan Patient chooses therapy and device after being presented all options
  • 37. REFERENCE- • Jerreat, Lynne. Diabetes for Nurses. London: Whurr, 1999. Print. • IOH Diabetes Treatment - Insulin Delivery Devices." Diabetes Assistance - Assistance Programs for Diabetes, Diabetes Laws, Insurance Laws. 11 Mar. 2006. Web. 24 Feb. 2011. <http://www.isletsofhope.com/diabetes/treatment/insulin_devices_1.html>. • Sattley, Melissa. "The History of Diabetes - Diabetes Health." Diabetes Health - Investigate, Inform, Inspire. 17 Dec. 2008. Web. 24 Feb. 2011. <http://www.diabeteshealth.com/read/2008/12/17/715/the-history-of- diabetes/>. • Richard. "History Of Insulin Pumps." Diabetes | Type 1 Diabetes | Type 2 Diabetes. 17 Apr. 2008. Web. 24 Feb. 2011. <http://www.dlife.com/diabetes- forum/viewtopic.php?f=22&t=10964&start=0&sid=46065bf7bcb0a2ec5f38f0 a3b95ed542&view=print>. • MiniMed. "Minimed ® Paradigm Revel ™ Insulin Pump MMDMMT523B." Medical Supplies - Discount Home Medical Supply & Equipment Store. Web. 24 Feb. 2011. <http://www.onlinemedicalsupply.com/DIABETIC/INSULIN_PRODUCTS/M MDMMT523B/product.aspx>.
  • 38. • Noida. "Global Insulin Pumps Market Set for Stupendous Upsurge by 2015." Press Release Distribution, Public Relations Services | SBWire. 16 Feb. 2011. Web. 24 Feb. 2011. <http://www.sbwire.com/press-releases/sbwire- 79053.htm>. • Reuters. "Artificial Pancreas Shows Promise in Pregnancy| Reuters." Business & Financial News, Breaking US & International News | Reuters.com. Reuters, 30 Jan. 2011. Web. 24 Feb. 2011. <http://www.reuters.com/article/2011/01/31/us-pancreas-diabetes- idUSTRE70U00N20110131>. • American Diabetes Association. "How Do Insulin Pumps Work?" American Diabetes Association Home Page - American Diabetes Association. Web. 24 Feb. 2011. <http://www.diabetes.org/living-with-diabetes/treatment-and- care/medication/insulin/insulin-pumps-how-do-insulin.html>. • www.slideshar.com • www.youtube.com • www.google.com