1. Why most diabetics don’t use the insulin pump Saad Sakkal.MD.FACE. Aleppo.Syria

2. The fact Insulin Pump is clearly a successful,effective method for glycemic control. Insulin Pump is clearly a successful,effective method for glycemic control. But it is still underused for a variety of reasons:expense to initiate and maintain, skilled patients and providers who would best fit its style leading sometimes to high discontinuation rate in some centers (30%). But it is still underused for a variety of reasons:expense to initiate and maintain, skilled patients and providers who would best fit its style leading sometimes to high discontinuation rate in some centers (30%).

3. The Hypothesis Hypothesis of this trial was : Hypothesis of this trial was : using Humalink software system would help us find patient related, provider related,or disease related factors which may explain why most insulin treated patients are not using the pump, even if expense was covered, and to improve rate of use using Humalink software system would help us find patient related, provider related,or disease related factors which may explain why most insulin treated patients are not using the pump, even if expense was covered, and to improve rate of use

4. Methods” Software 1) Software : Humalink is a well proven, validated,effective software for better glycemic control after application in more than 800 patients (from young to old, pregnant to adolescent,or Islet cell transplant to any poorly controlled patients).see references (1-8 /years 1986- 2005). 1) Software : Humalink is a well proven, validated,effective software for better glycemic control after application in more than 800 patients (from young to old, pregnant to adolescent,or Islet cell transplant to any poorly controlled patients).see references (1-8 /years 1986- 2005).

5. Methods:Patients 2)Patients : 87 insulin treated diabetics who were Insulin Pump therapy candidates because of poor glycemic control (HgA1c>9%, Gl>250 mg/dl),were offered to use the Humalink software via a touchtone telephone, in preparation for Insulin Pump therapy. 2)Patients : 87 insulin treated diabetics who were Insulin Pump therapy candidates because of poor glycemic control (HgA1c>9%, Gl>250 mg/dl),were offered to use the Humalink software via a touchtone telephone, in preparation for Insulin Pump therapy.

6. patients Patients were using 2 -3 injections daily,updated fully on diabetic education, and,taught how to use Humalink from their home phone in 2 sessions. Patients were using 2 -3 injections daily,updated fully on diabetic education, and,taught how to use Humalink from their home phone in 2 sessions. They were given a protected personal access number to the system They were given a protected personal access number to the system

7. Methods:protocol 3)Protocol : Patients were asked to call 4 BGSM values twice weekly. Instantly,the system analyzed their previous glucose profile data ( up to 90 days),gave an instant response with any appropriate modifications on Insulin Am or Pm dose (rapid or intermediate). 3)Protocol : Patients were asked to call 4 BGSM values twice weekly. Instantly,the system analyzed their previous glucose profile data ( up to 90 days),gave an instant response with any appropriate modifications on Insulin Am or Pm dose (rapid or intermediate).

8. System response and reminded them of due metabolic outcome measurements (HgA1c,fructosamine,Triglycerides,Cholest erol, etc. Similar to the DCCT protocol and reminded them of due metabolic outcome measurements (HgA1c,fructosamine,Triglycerides,Cholest erol, etc. Similar to the DCCT protocol

9. Methods : protocol. After patient agreed to the protocol, We quantitated at 6,9,12 months the following :. After patient agreed to the protocol, We quantitated at 6,9,12 months the following : 1)Patient related factors : 1)Patient related factors : Compliance with the protocol(initiating use of the system as instructed), Compliance with the protocol(initiating use of the system as instructed), Adherence (persistent regular use after initiation). Adherence (persistent regular use after initiation).

10. protocol 2)Provider related factors (patients who became well controlled by the system,after provider inability to achieve optimum control ). 2)Provider related factors (patients who became well controlled by the system,after provider inability to achieve optimum control ). 3)Disease related factors (patients who continued to have poor control and needed at the end an Insulin pump). 3)Disease related factors (patients who continued to have poor control and needed at the end an Insulin pump).

11. Results Results : Results : Non-compliance was seen in 31% of patients (27 of 87 dropped out soon). Non-compliance was seen in 31% of patients (27 of 87 dropped out soon). Of the 60 compliant patients non- adherence was seen in 10%(6 of 60 did not use the system regularly). Of the 60 compliant patients non- adherence was seen in 10%(6 of 60 did not use the system regularly).

12. Results Results Of the adhering patients 97.2% improved in all parameters, indicating provider related factors which was appropriately corrected not needing insulin pump. Of the adhering patients 97.2% improved in all parameters, indicating provider related factors which was appropriately corrected not needing insulin pump. Only 2.7% did not improve despite good Compliance and Adherence indicating disease related factors,and, clearly representing the best candidates for insulin pump who would comply, adhere and not discontinue the pump Only 2.7% did not improve despite good Compliance and Adherence indicating disease related factors,and, clearly representing the best candidates for insulin pump who would comply, adhere and not discontinue the pump

13. Outcome measures results:. A brief summary of improved outcome measures include decreased :. A brief summary of improved outcome measures include decreased : a)FBS from 167 to 140.mg/dl. a)FBS from 167 to 140.mg/dl. b)2HPP glucose from 194 to 152. b)2HPP glucose from 194 to 152. c) HgA1c from 9.7% to 7.9%. c) HgA1c from 9.7% to 7.9%. d)Fructosamine from 348 to 294. d)Fructosamine from 348 to 294.

14. Outcome measures ;cont e)triglycerides from 330 to 196. e)triglycerides from 330 to 196. f) Cholesterol from 261 to 200. f) Cholesterol from 261 to 200. g)Hypoglycemia /pt/m. from 3% to 0.7%. g)Hypoglycemia /pt/m. from 3% to 0.7%. h) Hyperglycemia/pt/m from 5% to 2%. h) Hyperglycemia/pt/m from 5% to 2%. i)insulin dose decresed : 22% i)insulin dose decresed : 22% and weight was stable : 81Kgs and weight was stable : 81Kgs

15. Statistical difference All described changes are significant at P value <0.001. All described changes are significant at P value <0.001. For comparison In the non users of the system HgA1c increased 0.4%. For comparison In the non users of the system HgA1c increased 0.4%. Absolute difference of HgA1c : % 2.2 for comparison Oral agents %.5 -1.1 Absolute difference of HgA1c : % 2.2 for comparison Oral agents %.5 -1.1

16. conclusion Conclusion : Conclusion : Humalink better glycemic control software helps in selection of the best candidate for insulin pump therapy. Humalink better glycemic control software helps in selection of the best candidate for insulin pump therapy.

17. conclusion factors in Subgroups who do not need or benefit from it as this trial shows are : factors in Subgroups who do not need or benefit from it as this trial shows are : Patient related factors %41 ; like Patient related factors %41 ; like non compliance(31%), non compliance(31%), non adherence (10%) non adherence (10%)

18. conclusion provider related factors : (57%), provider related factors : (57%), Disease related factors : (2%) which benefits best from the pump if expense covered Disease related factors : (2%) which benefits best from the pump if expense covered

19. Humalink Project team: Vickie Huston Vickie Huston Carolyn Wright RN Carolyn Wright RN Michael Albisser Phd Michael Albisser Phd Saad Sakkal MD Saad Sakkal MD Work done at the Metabolic Care Center in Greenville /Pennsylvania/USA. Work done at the Metabolic Care Center in Greenville /Pennsylvania/USA.

20. Internet Humalink www/nidm/org. www/nidm/org. For information and littreture: For information and littreture: ssakkal@msn/com ssakkal@msn/com

21. Thanks M.G.S.D. Thanks Servier The Mediterranian is not just a sea. The Mediterranian is not just a sea. Its water flow in our blood. Its water flow in our blood. Its diet effects us all. Its diet effects us all. It unites us as civilization.culture.people. It unites us as civilization.culture.people. It unites us as past.present and future. It unites us as past.present and future. It is ordained destiny. It is ordained destiny. We love it. We love it.