New Insulins and Insulin Delivery Systems Bruce W
New Insulins and Insulin Delivery Systems Bruce W. Bode, MD, FACE Atlanta Diabetes Associates Atlanta, Georgia
Prevalence of Diabetes in the US Diagnosed Type 2 Diabetes 10. 3 Million Diagnosed Type 1 Diabetes 0. 5 – 1. 0 Million Undiagnosed Diabetes 5. 4 Million American Diabetes Association. Facts and Figures. Available at: http: //www. diabetes. org/ada/facts. asp. Accessed January 18, 2000.
Goals of Intensive Insulin Therapy l Maintain near normal glycemia l Avoid short-term crisis l Minimize long-term complications l Improve the quality of life 0 12 Hours 24
ACE / AACE Targets for Glycemic Control A 1 C (Hb. A 1 c) < 6. 5 % Fasting/preprandial glucose< 110 mg/d. L Postprandial glucose < 140 mg/d. L ACE / AACE Consensus Conference, Washington DC August 2001
Specific Goals in Management of Diabetes l Fasting or premeal BG 70 to 140 mg/d. L l Post-meal < 140 to 160 mg/d. L l A 1 C < 6. 5 to 7. 0% l Blood Pressure < 130/80 l LDL < 100 mg/d. L; HDL > 45 mg/d. L l Triglycerides < 150 mg/d. L
Insulin The most powerful agent we have to control glucose
The Miracle of Insulin Patient J. L. , December 15, 1922 February 15, 1923
Progression of Type 1 Diabetes Precipitating Event Beta-cell mass Genetic predisposition Antibody Normal insulin release Progressive loss of insulin release Glucose normal Overt diabetes C-peptide present No C-peptide present Age (y) Adapted from: Atkinson. Lancet. 2002; 358: 221 -229.
Options in Insulin Therapy for Type 1 Diabetes l Current – Multiple injections – Insulin pump (CSII) l Future – Implant (artificial pancreas) – Transplant (pancreas; islet cells)
Type 2 Diabetes … A Progressive Disease Over time, most patients will need insulin to control glucose
Type 2 Diabetes: Two Principal Defects Genes Insulin resistance b-cell dysfunction/ failure ± Environment IGT Glucose Toxicity IGT Type 2 diabetes Reaven GM. Physiol Rev. 1995; 75: 473 -486 Reaven GM. Diabetes/Metabol Rev. 1993; 9(Suppl 1): 5 S-12 S; Polonsky KS. Exp Clin Endocrinol Diabetes. 1999; 107 Suppl 4: S 124 -S 127. Glucose Toxicity
A 1 C in the UKPDS
b-Cell Function (% b) UKPDS: b-Cell Function for the Patients Remaining on Diet for 6 Years N=376 Years After Diagnosis Adapted from UKPDS Group. Diabetes. 1995; 44: 1249 -1258.
Multiple factors may drive progressive decline of b-cell function Hyperglycaemia (glucose toxicity) Insulin resistance Protein glycation b-cell (genetic background) Amyloid deposition “lipotoxicity” elevated FFA, TG
Management of Type 2 DM Step Therapy l Diet l Exercise l Sulfonylurea or Metformin l Add Alternate Agent l Add hs NPH vs TZD l Switch to Mixed Insulin bid l Switch to Multiple Dose Insulin Utilitarian, Common Sense, Recommended Prone to Failure from Misscheduling and Mismanagement
Management of Type 2 DM Stumble Therapy l WAG Diet l Golf Cart Exercise l Sample of the Week Medication – Interrupted – Not Combined l Poor Understanding of Goals l Poor Monitoring Hb. A 1 c >8% (If Seen)
Consider A New Treatment Paradigm l Treatment designed to correct the dual impairments l Vigorous effort to meet glycemic targets l Simultaneous rather than sequential therapy l Combination therapy from the outset l Early step-wise titrations to meet glycemic targets
Approach to Combination Oral Therapy Intensifying of Oral Therapies metformin &/or glitazone + sulfonylurea/repaglinide &/or glucosidase inh FPG <110 mg/dl Continue A 1 C <6. 5% sulfonylurea/repaglinide &/or glucosidase inh + metformin &/or glitazone FPG >110 mg/dl Add Insulin A 1 C >6. 5%
Comparison of Human Insulins / Analogues Insulin Onset of Duration of preparations action Peak action Regular 30– 60 min 2– 4 h 6– 10 h NPH/Lente 1– 2 h 4– 8 h 10– 20 h Ultralente 2– 4 h Lispro/aspart 5– 15 min 1– 2 h 4– 6 h Glargine 1– 2 h Flat ~24 h Unpredictable 16– 20 h
Insulin Aspart (Novo. Log ) Regular Human Insulin Subcutaneous Tissue Dissociation & Absorption of Novo. Log Peak Time = 40 -50 min Capillary Membrane Peak Time = 80 -120 min
Short-Acting Insulin Analogs 400 Regular Lispro 350 300 250 200 150 100 50 0 0 30 60 90 120 150 180 210 240 Plasma insulin (pmol/L) Lispro and Aspart Plasma Insulin Profiles 500 450 400 350 300 250 200 150 100 50 0 Regular Aspart 0 50 Time (min) Meal SC injection 100 150 200 Time (min) Meal SC injection Heinemann, et al. Diabet Med. 1996; 13: 625– 629; Mudaliar, et al. Diabetes Care. 1999; 22: 1501– 1506. 250 300
Pharmacokinetic Comparison Aspart vs Lispro 350 Aspart Free Insulin (pmol/L) 300 Lispro 250 200 150 100 50 0 7 8 Hedman, Diabetes Care 2001; 24(6): 1120 -21 9 10 Time (hours) 11 12 13
Limitations of NPH, Lente, and Ultralente l Do not mimic basal insulin profile – Variable absorption – Pronounced peaks – Less than 24 -hour duration of action l Cause unpredictable hypoglycemia – Major factor limiting insulin adjustments
Insulin Glargine (Lantus) A New Long-Acting Insulin Analog l Modifications to human insulin chain – Substitution of glycine at position A 21 – Addition of 2 arginines at position B 30 l Gradual release from injection site l Peakless, long-lasting insulin profile Gly 1 5 10 15 20 Asp 1 5 10 15 20 Substitution 25 30 Extension Arg
Glargine vs NPH Insulin in Type 1 Diabetes Action Profiles by Glucose Clamp Glucose utilization rate (mg/kg/h) 6 NPH Glargine 5 4 3 2 1 0 0 10 20 30 Time (h) after SC injection End of observation period Lepore, et al. Diabetes. 1999; 48(suppl 1): A 97.
Overall Summary: Glargine l Insulin glargine has the following clinical benefits – Once-daily dosing because of its prolonged duration of action and smooth, peakless timeaction profile (mean 23. 5 hours) – Comparable or better glycemic control (FBG) – Lower risk of nocturnal hypoglycemic events – Safety profile similar to that of human insulin
Primary Structure of Lys(B 29)-N- Tetradecanoyl, Des(B 30)-Insulin Detemir Gly Glu Phe Tyr Thr Pro Lys Thr 23 24 25 26 27 28 29 30 Gly Glu Phe Tyr Thr Pro Lys (CH 2)4 NH CO R Thr
Insulin Detemir in Nondiabetic Subjects— Pharmacokinetics by Glucose Clamp Glucose infusion rate (mg/kg/min) 2. 0 1. 5 1. 0 Detemir-high Detemir-low 0. 5 0. 0 -100 Placebo 100 300 500 700 900 1100 1300 1500 Elapsed time (min) Brunner GA, et al. Exp Clin Endocrinol Diabetes. 2000; 108: 100 -105. 28
Conclusions From Phase 2 and 3 Studies Insulin detemir in comparison to NPH: l Lowers A 1 C as effectively l Lowers FPG significantly more Provides significantly lower intra-subject variation of fasting blood glucose (more predictable) Produces a smoother nocturnal glucose profile Causes a lower incidence of hypoglycaemia Associated with some weight loss Causes no safety concerns l l l
Physiological Serum Insulin Secretion Profile Plasma insulin (µU/ml) 75 Breakfast Lunch Dinner 50 25 4: 00 8: 00 12: 00 16: 00 Time 20: 00 24: 00 8: 00
Basal/Bolus Treatment Program with Rapid-acting and Long-acting Analogs Plasma insulin Breakfast Lunch Dinner Aspart or or or Lispro Glargine or Detemir 4: 00 8: 00 12: 00 16: 00 Time 20: 00 24: 00 8: 00
The Basal/Bolus Insulin Concept l Basal insulin – Suppresses glucose production between meals and overnight – 40% to 50% of daily needs l Bolus insulin (mealtime) – Limits hyperglycemia after meals – Immediate rise and sharp peak at 1 hour – 10% to 20% of total daily insulin requirement at each meal
Insulin Therapy in Type 2 Diabetes Indications l Significant hyperglycemia at presentation l Hyperglycemia on maximal doses of oral agents l Decompensation – – Acute injury, stress, infection, myocardial ischemia Severe hyperglycemia with ketonemia and/or ketonuria Uncontrolled weight loss Use of diabetogenic medications (eg, corticosteroids) l Surgery l Pregnancy l Renal or hepatic disease
Starting With Basal Insulin Advantages l 1 injection with no mixing l Insulin pens for increased acceptance l Slow, safe, and simple titration l Low dosage l Effective improvement in glycemic control l Limited weight gain 6 -37
Treat to Target Study: Glargine vs NPH Added to Oral Therapy of Type 2 Diabetes l Type 2 DM on 1 or 2 oral agents (SU, MET, TZD) l Age 30 to 70 l BMI 26 to 40 l A 1 C 7. 5 to 10% and FPG > 140 mg/d. L l Anti GAD negative l Willing to enter a 24 week randomized, open labeled study Riddle et al, Diabetes June 2002, Abstract 457 -p
Treatment to Target Study: NPH vs Glargine in DM 2 patients on OHA l Add 10 units Basal insulin at bedtime (NPH or Glargine) l Continue current oral agents l Titrate insulin weekly to fasting BG < 100 mg/d. L - if 100 -120 mg/d. L, increase 2 units - if 120 -140 mg/d. L, increase 4 units - if 140 -160 mg/d. L, increase 6 units - if 160 -180 mg/d. L, increase 8 units
Treatment to Target Study; A 1 C Decrease
Treat to Target Study: Glargine vs NPH Added to Oral Therapy of Type 2 Diabetes l Nocturnal Hypoglycemia reduced by 40% in the Glargine group (532 events) vs NPH group (886 events) Riddle et al, Diabetes June 2002, Abstract 457 -p
Advancing Basal/Bolus Insulin l Indicated when FBG acceptable but – A 1 C > 7% or > 6. 5% and/or – SMBG before dinner > 140 mg/d. L l Insulin options – To glargine or NPH, add mealtime aspart / lispro – To suppertime 70/30, add morning 70/30 – Consider insulin pump therapy l Oral agent options – Usually stop sulfonylurea – Continue metformin for weight control – Continue glitazone for glycemic stability?
Novo Nordisk devices in diabetes care First pen (Novo. Pen 1) launched in 1985 Committed to developing one new insulin administration system per year.
Lilly Insulin Pens
Novo Flex. Pen ® l 3 -m. L prefilled disposable pen offers precise dosing
® Novo. Log Flex. Pen ® 82% of DNEs Preferred Flex. Pen® ® Source: Diabetes Nurse Educators In-Depth Study—Reactions to Flex. Pen.
Novo Innolet ® Large push button with low resistance Maximum dose 50 units Clear & uncomplicated dial, dials forward and back Large-scale numbers Audible clicks 1 unit increments Contains 300 units Novolin® 70/30, NPH, or R Novo. Fine® disposable needle Needle storage compartment Support shoulder
In. Duo™ - Integration Feature l Combined insulin doser and blood glucose monitor
In. Duo™ - Doser Remembers Feature l Remembers amount of insulin delivered and time since last dose Benefit l Helps people inject the right amount of insulin at the right time
Starting MDI l Starting insulin dose is based on weight 0. 2 x wgt in lbs or 0. 45 x wgt in kg l Bolus dose (aspart/lispro) = 20% of starting dose at each meal l Basal dose (glargine/NPH) = 40% of starting dose at bedtime
Starting MDI in 180 lb person l Starting dose = 0. 2 x wgt. in lbs. 0. 2 x 180 lbs. = 36 units l Bolus dose = 20% of starting dose at each meal 20% of 36 units = 7 units ac (tid) l Basal dose = 40% of starting dose at bedtime 40% of 36 units = 14 units at HS
Correction Bolus l Must determine how much glucose is lowered by 1 unit of short- or rapid-acting insulin l This number is known as the correction factor (CF) l Use the 1700 rule to estimate the CF l CF = 1700 divided by the total daily dose (TDD) ex: if TDD = 36 units, then CF = 1700/36 = ~50 meaning 1 unit will lower the BG ~50 mg/dl
Correction Bolus Formula Current BG - Ideal BG Glucose Correction factor Example: – Current BG: – Ideal BG: 220 mg/dl 100 mg/dl – Glucose Correction Factor: 50 mg/dl 220 - 100 =2. 4 u 50
Options to MDI l A Simpler Regimen l Insulin Pump l Premixed BID (DM 2 only)
Human Insulin Time-action Patterns Change in serum insulin Normal insulin secretion at mealtime Regular insulin NPH insulin Premix 70/30 Baseline level SC injection Time (h)
A More Physiologic Insulin Change in serum insulin Normal insulin secretion at mealtime Novo. Log NPH insulin Novo. Log Mix 70/30 Baseline Level Time (h) SC injection
Analog Mix 70/30: Serum Insulin Levels in Type 2 Diabetes * * Novo. Log® Mix 70/30 Premix Serum insulin (m. U/L) 100 Cmax 80 60 40 20 0 6: 00 PM 10: 00 PM 8: 00 AM Dinner *P<0. 05. Mc. Sorley. Clin Ther. 2002; 24(4): 530 -539. Breakfast Time 1: 00 PM Lunch 6: 00 PM
Aspart Mix 70/30: Serum Glucose Levels in Type 2 Diabetes * Serum glucose (mg/d. L) 300 Aspart Mix 70/30 Premix * * 250 200 150 0 6: 00 PM 10: 00 PM Dinner *Glucose excursions 0 -4 h, P<0. 05. Mc. Sorley. Clin Ther. 2002; 24(4): 530 -539. 8: 00 AM Breakfast 1: 00 PM Lunch 6: 00 PM
Analog Mix 70/30 vs 75/25 vs 70/30 Premix: Serum Insulin Levels in Type 2 Diabetes Serum insulin (m. U/L) 80 Aspart Mix 70/30 Lispro Mix 75/25 70/30 Premix 60 40 20 0 0 1 2 Time (h) Hermansen. Diabetes Care. 2002; 25(5): 883 -888. 3 4 5
Case #2: DM 2 on 70/30 l 60 year old black male l DM 2 age 56; Ht 69”; Wgt 180 l Failed oral agents l On 70/30 BID: 10 u am and pm l Hb. A 1 c 8. 4% SMBG 144 on 0. 8 tests/day l Increased 70/30, tried 3 xday, still not at goal
Case #2: DM 2 on 70/30 l Finally agrees to MDI l Starting dose: 0. 2 x wgt in # (36 u) l Bolus: 20% pre-meal (7 u ac tid) l Basal: 40% Bedtime or anytime (14 u HS) l Correction Factor: 1700 divided by TDD (50 mg/dl) l Does great - A 1 C 6. 4% l Current dose: 4 u am, 4 u noon, 10 u pm, 16 u Lantus HS
Variable Basal Rate: CSII Program Plasma insulin Breakfast Lunch Bolus Dinner Bolus Basal infusion 4: 00 8: 00 12: 00 16: 00 Time 20: 00 24: 00 8: 00
PARADIGM PUMP Paradigm. Simple. Easy.
Pump Infusion Sets
Metabolic Advantages with CSII l Improved glycemic control l Better pharmacokinetic delivery of insulin – Less hypoglycemia – Less insulin required l Improved quality of life
Hb. A 1 c CSII Reduces Hb. A 1 c 10. 0 9. 5. 09 8. 5 8. 0 7. 5 7. 0 6. 5 6. 0 5. 5 5. 0 Pre-pump Bell Rudolph n = 58 n = 107 Mean dur. = 36 Adults Post-pump Chanteleau Bode Boland n = 116 Mean dur. = 54 n = 50 Mean dur. = 42 n = 25 Mean dur. = 12 Adolescents Chantelau E, et al. Diabetologia. 1989; 32: 421– 426; Bode BW, et al. Diabetes Care. 1996; 19: 324– 327; Boland EA, et al. Diabetes Care. 1999; 22: 1779– 1784; Bell DSH, et al. Endocrine Practice. 2000; 6: 357– 360; Chase HP, et al. Pediatrics. 2001; 107: 351– 356. Chase n = 56 Mean dur. = 12
Insulin Reduction Following CSII -28% * n = 389 * P <0. 001 n = 389 -18% -16% -17% * * * n = 298 n = 246 n = 187
CSII Factors Affecting A 1 C l Monitoring – A 1 C = 8. 3 - (0. 21 x BG per day) l Recording 7. 4 vs 7. 8 l Diet practiced – CHO: 7. 2 – Fixed: 7. 5 – WAG: 8. 0 l Insulin type (Aspart) Bode et al. Diabetes 1999; 48 Suppl 1: 264 Bode et al. Diabetes Care 2002; 25 439
Insulin aspart versus buffered R versus insulin lispro in CSII study: Insulin aspart Screening – 2 weeks l Buffered regular human insulin (Velosulin®) Insulin lispro 0 weeks 146 patients in the USA; 2– 25 years with Type 1 diabetes; 7% Hb. A 1 c 9%; previously treated with CSII for 3 months Bode et al: Diabetes Care, March 2002 16 weeks
Glycemic Control with CSII 8. 0 Novo. Log® Human insulin Humalog® Type 1 Diabetes Hb. A 1 c (%) 7. 8 7. 6 7. 4 7. 2 7. 0 0 Baseline Week 8 Week 12 Week 16 Bode, Diabetes 2001 ; 50(S 2): A 106
Self-Monitored Blood Glucose in CSII Blood Glucose (mg/dl) 220 Novo. Log® Buffered Regular Humalog® 200 180 160 * * 140 120 Type 1 Diabetes 100 80 * Before and 90 min. after breakfast Before and 90 min. after lunch Bedtime 2 AM Before and 90 min. after dinner Bode, Diabetes 2001 ; 50(S 2): A 106
Symptomatic or Confirmed Hypoglycaemia p < 0. 05 Episodes/month/patient p < 0. 05 12 30% relative reduction 10 8 6 4 2 0 insulin aspart Bode et al: Diabetes Care, March 2002 human insulin lispro
DM 1 CSII Patient: Lispro to Aspart Lispro Average = 140 SD = 118 Aspart Average = 118 SD = 73
Glycemic Control in Type 2 DM: CSII vs MDI in 127 patients l A 1 C Baseline End of Study (24 wks) 8. 4 8. 2 8. 0 7. 8 7. 6 7. 4 7. 2 7. 0 CSII Raskin et al. Diabetes 2001; 50 Suppl 2: A 128 MDI
CSII vs MDI in DM 2 Patients CSII MDI Less Pain Less Social Limitations Preference * ** Advocacy Less Hassle * * Less Life Interference *** General Satisfaction Flexibility *** Convenience Less Burden *** -5 0 5 10 15 20 25 30 Change in Scores (Raw Units) From Baseline to Endpoint Raskin et al. Diabetes 2001; 50 Suppl 2: A 128 35
Case 3: DM 2 Poorly Controlled l 58 year old female presented with a 12 year history of poorly controlled, insulin treated diabetes l Ht 66’’, Wt 174#, BMI 28, C-peptide 2. 1 l A 1 C 10. 4% on 165 units per day (70/30 BID) l Added troglitazone, metformin, glimepiride to MDI insulin l A 1 C range 7. 7 to 12. 6% over 3 years
Case 3: DM 2 Poorly Controlled l Admitted twice for IV insulin and fasting with short lived success (A 1 C to 7. 6% but back up to 12. 6%) l Tried weight watchers and appetite suppressants; no help l Decided to try CSII
Case 3: DM 2 on CSII, A 1 C Results
Case 3: DM 2 Poorly Controlled l Patient loves the pump l On 110 units per day consuming 2 meals only per day (1. 4 units per kg or 0. 6 units per lbs) l Also on rosiglitazone 4 mg/day
Normalization of Lifestyle l Liberalization of diet — timing & amount l Increased control with exercise l Able to work shifts & through lunch l Less hassle with travel — time zones l Weight control l Less anxiety in trying to keep on schedule
Current Continuation Rate Continuous Subcutaneous Insulin Infusion (CSII) Continued 97% Discontinued 3% N = 165 Average Duration = 3. 6 years Average Discontinuation <1%/yr Bode BW, et al. Diabetes. 1998; 47(suppl 1): 392.
U. S. Pump Usage Total Patients Using Insulin Pumps
Current Pump Therapy Indications l Diagnosed with diabetes (even new onset DM 1) l Need to normalize blood glucose (BG) – A 1 C 6. 5% – Glycemic excursions l Hypoglycemia
Poor Candidates for CSII l Unwilling to comply with medical follow-up l Unwilling to perform self blood glucose monitoring 4 times daily l Unwilling to quantitate food intake
Pump Therapy Basal rate l Continuous flow of insulin l Takes the place of NPH or glargine insulin Units 6 5 4 3 2 1 12 am Meal boluses l Insulin needed pre-meal – Pre-meal BG – Carbohydrates in meal – Activity level l Correction bolus for high BG Meal bolus Basal rate 12 pm Time of day 12 am
Initial Adult Dosage Calculations Starting Doses – Based on pre-pump Total Daily Dose (TDD) Reduce TDD by 25 -30% for Pump TDD – Calculated based on weight 0. 24 x wgt in pounds (0. 5 x wgt in kg) Bode BW, et al. , Diabetes 1999, (Suppl 1): 84. Bell D and Ovalle F, Endocrine Practice 2000, 6: 357 -360. Crawford, LM, Endocrine Practice 2000, 6: 239 -43.
Initial Adult Dosage Calculations Basal Rate – 50% of pump Total Daily Dose – Divide total basal by 24 hours to decide on hourly basal – Start with only one basal rate – See how it goes before adding additional basals
Basal Dose Adjustment Rule of 30: Basal Rate(s) Adjustments Overnight – Check BG ü Bedtime ü 12 AM ü 3 AM ü 7 AM – Adjust overnight basal if readings vary > 30 mg/dl
Initial Dosage Calculations Meal (food) Bolus – Usually 50% of Pump Total Daily Dose – Marjorie C. • Total Daily Dose 40 Units • Basal Rate 20 Units • Meal Bolus (total) 20 Units
Initial Dosage Calculations Meal (food) Bolus Method - Divide total bolus dose by 3 - Test BG before meal - Give correction bolus - Give pre-determined insulin dose for predetermined CHO content - Test BG after meal
Estimating the Carbohydrate to Insulin Ratio (CIR) Individually determined CIR = (2. 8 x wgt in lbs) / TDD Anywhere from 5 to 25 g CHO is covered by 1 unit of insulin
What Type of Bolus Should You Give? Immediate vs Square vs Dual Wave l 9 DM 1 patients on CSII ate pizza and coke on four consecutive Saturdays l Dual wave bolus (70% at meal, 30% as 2 -h square): 9 mg/dl glucose rise l Single bolus: 32 mg/dl rise l Double bolus at -10 and 90 min: 66 m/dl rise l Square wave bolus over 2 hours: 79 m/dl rise Chase et al, Diabetes June 2001 #365
Treatment of Hyperglycemia l If blood glucose is above 250 mg/dl – Take a correction bolus by pump – Check BG again in 1 hr l If still above 250 mg/dl – Take correction bolus by syringe – Change infusion set and reservoir – Check BG again in 1 hr l If BG has not decreased – Increase correction bolus by syringe – CALL PHYSICIAN
Prevention of Hypoglycemia l Monitor BG – 4 -6 times a day – Set appropriate BG target range l Set minimum BG level before sleep – Never < 90, unless pregnant
If A 1 C is Not to Goal Must look at: l SMBG frequency and recording l Infusion site areas – Are they in areas of lipohypertrophy? l Diet practiced – Do they know what they are eating? – Do they bolus for all food and snacks? l Other factors: – Fear of low BG – Overtreatment of low BG
If A 1 C Not to Goal and No Reason Identified l. Place on a continuous glucose monitoring system (CGMS by Medtronic Minimed, Glucowatch by Cygnus) to determine the cause
Cygnus Gluco. Watch G 2 – Watch Component – Electrode Component – Initial calibration takes 2 hours – Senses glucose and gives an average every 10 minutes up to 13 hours (r = 0. 84 home use) – Alarm for high, low and rapidly dropping blood sugars Cygnus Gluco. Watch
GLUCOSE MONITORING SYSTEMS - EXTERNAL Physician Product l Physician downloads data for retrospective analysis l Com-Station and software packages combine data from: – Sensor – Models 508 and 507 C insulin pumps – Traditional glucose meters
CGMS
CGMS Sensor
Glucose Profiles Patient with Type 1 Diabetes 350 – Practicing MDI – Complications of High BG Renal Retinal Neural Glucose Concentration (mg/dl) – Hb. A 1 C of 8. 5% 300 250 200 150 100 50 0 12: 00 Midnight Meal 6: 00 AM Meal 12: 00 Noon Time Meal 6: 00 PM 12: 00 Midnight Pre-Meal BG Tests
Glucose Profiles Patient with Type 1 Diabetes 350 – Hb. A 1 C of 8. 5% 300 – Complications of High BG Renal Retinal Neural Glucose Concentration (mg/dl) – Practicing MDI 250 200 150 100 50 0 12: 00 Midnight Meal 6: 00 AM Meal 12: 00 Noon Time Meal 6: 00 PM 12: 00 Midnight Glucose Monitor Pre-Meal BG Tests
Reasons to Use CGMS l. Improve glycemic control l. Reduce risk of hypoglycemic events l. Minimize risk of future hypoglycemia
GLUCOSE MONITORING SYSTEMS Telemetry Consumer Product l “Real time” glucose readings l Wireless communication from sensor to monitor l High and low glucose alarms l FDA panel pending
Closed-loop control using an external insulin pump and a subcutaneous glucose sensor + subcutaneous glucose sensor Insulin infusion pump (currently Mini. Med 508)
The Long-Term Sensor System: a prototype of implantable artificial pancreas Sensor Tip Inlet to Pump Catheter Header with Inlet Port Abdominal Lead Assembly (ALA) Sensor Connection to the Pump Catheter Tip for Insulin Delivery
Medtronic Minimed Artificial Pancreas
Blood Glucose Profile, Before, During and After Closed Loop using LTSS 450 400 350 closed loop Glucose (mg/d. L) 300 250 200 150 100 50 0 26 Sun Aug 2001 27 Mon 28 Tue 29 Wed 30 Thu 31 Fri 1 Sep 2 Sun
Distribution of Blood Glucose One Week Before and During 48 H-‘Closed-Loop E. Renard et al, Lapeyronie Hospital, Montpellier, France Reference Point Range Before Closed-Loop During ‘Closed. Loop ’ < 70 mg/dl 25 % 14 % 70 -120 mg/dl 25 % 60 % 120 -240 mg/dl 45 % 26 % > 240 mg/dl 5% 0% 116 35 105 45 Average Glucose (mg/dl) Daily Insulin Use (IU)
Summary l Insulin remains the most powerful agent we have to control diabetes l When used appropriately in a basal/bolus format, near-normal glycemia can be achieved l Newer insulins and insulin delivery devices along with glucose sensors will revolutionize our care of diabetes
Billing l Get paid for what you do l Use your codes and negotiate for coverage l Detailed visit: 99214 l Prolonged visit with contact plus above: 99354 or 99355 (insulin start or pump start) l Prolonged visit w/o contact plus above: 99358 or 59 (faxes, phone calls, emails)
Billing l Bill faxes as prolong visits with out contact or negotiate a separate charge l Bill meter download: 99091 l Bill CGMS: 95250 l Bill immediate A 1 C: 83036
Questions l For a copy or viewing of these slides, contact l WWW. adaendo. com
- Slides: 111