Computer-Assisted Decision Support (CADS) for Primary Care of Diabetes Mellitus
Robert Vigersky, M.D., COL, MC1
Robert Galen, M.D., M.P.H.2
David Horne3 Michael Cavotta3 David Rodbard, M.D.4
1Walter
Reed Army Medical Center, 2University of Georgia, 3LifeClinic, Inc., 4American Institutes of Research
American Telemedicine Association 14 MAY 2007
Problem to be Solved
How to improve the long-term outcomes of patients with diabetes given the following:
The vast majority of patients with diabetes are managed by Primary Care Providers (PCPs) The explosion in number of treatment alternatives (oral agents, combination therapy, and insulins) makes it more difficult for PCPs to be familiar with available options and algorithms
Solution
Develop a computer-assisted decision support (CADS) program which integrates: Automated analysis of data from memory meters Current and past treatment Laboratory data (e.g. creatinine, liver enzymes)
It must have the following features: Rapid, easy, customization of a treatment plan for each patient, relying on a series of „default‟ plans Automated interpretation of the “Glucose profile” to identify and prioritize problems Recommendations to modify the existing treatment regimes Recommendations for moving to another treatment regimen
Architecture of the System
Patient Module
-Interface with Patient's Meter via PC/modem -Graphs -Statistics -Meal/Med/Exercise Entry -Educational Material
Provider Module
-Glucose Profile Interpretation -Customize Treatment Plan -Clinical Decision Support -Links
CADS
AHLTA
Clinical Data Repository
Administrator Module
-Default Treatment Options -Target Ranges - Sequence of doses/regimens -Formulary - Rules for interpretation
CADS Module
1. Analysis of the glucose profile
(Q Scores) a. Overall level of control - % in target range - Median - % low and “Hypoglycemia score (Mean of (80 - glucose) - % high and “Hyperglycemia score Mean of (glucose - 120) - calculated/predicted A1c b. Overall score: Weighted average using "penalty function" 2. Adequacy of Monitoring 3. Patterns Post-prandial fluctuations Trends during day or night "Somogyi reaction“ Dawn Phenomenon 4. Identification/prioritization of problem 5. Adjustment of doses for current regimen 6. Consideration of alternative regimens 7. Recommendations for laboratory studies and safety alerts
c. Hypoglycemia
d. Hyperglycemia e. Variability
Regimen Type 1
Regimen Type 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Drug1 diet M S M M S M M S M M S M M S M M S M T T Glargine S T T S T S T T S T S T T S T Glargine Glargine Glargine Glargine Glargine Glargine NPH NPH NPH NPH NPH NPH Drug2 diet Drug3 diet Drug4 Drug5
22
T
NPH
I-1 I-2 I-3 I-4 I-5
23 24 25 26 27
aspart aspart aspart aspart aspart
NPH AM NPH AM aspart aspart aspart
aspart PM aspart PM aspart aspart aspart
glargine PM NPH PM glargine NPH glargine AM glargine PM
Identification of Oral Agents Responsible for Glucose for Specified Times
Time of day 1 FBS (BB) 1 Regim en di et m et S M +S M +T S+ T M+ S+T Lant us Lan tus Lan tus L a nt u s M + T M + T M + T M + T M + T M + T M + T Lan tus N P H M NPH NP H NP H NPH 2 3 4 5 6 7 8 9 10 1 1 12 1 3 14 15 16 17
2
AB
di et di et di et di et di et di et di et
m et m et m et m et m et m et m et
S
M +S M +S M +S M +S M +S M +S M +S
M +T M +T M +T M +T M +T M +T M +T
S+ T S+ T S+ T S+ T S+ T S+ T S+ T
M+ S+T M+ S+T M+ S+T M+ S+T M+ S+T M+ S+T M+ S+T
M
S
M+ S M+ S M+ S M+ S M+ S M+ S M+ S
S+ T S+ T S+ T S+ T S+ T S+ T S+ T
S
M+ S M+ S M+ S M+ S M+ S M+ S M+ S
M+ T M+ T M+ T M+ T M+ T M+ T M+ T
S+T
3
BL
S
M
S
M
S
S+T
4
AL
S
M
S
M
S
S+T
5
BD
S
M
S
M
S
S+T
6
AD
S
M
S
M
S
S+T
7
BT
S
M
S
M
S
S+T
8
4AM
S
M
S
M
S
S+T
Insulin Responsible for Glucose for Specified Periods
Time of day Regimen 1 2 3 4 5 6 7 8
1
FBS (BB)
BD “70/30”
BT NPH
BT Lantus
BT NPH
BT Lantus
BT NPH
BT Lantus
BT Lantus
2
AB
BB “70/30”
BB “70/30”
BB Aspart
BB Aspart
BB Aspart
BB Aspart
BB Aspart
BB Aspart
3
BL
BB “70/30”
BB “70/30”
BB Aspart
BB Aspart
BB Aspart
BB Aspart
BB Aspart
BB Aspart
4
AL
BB “70/30”
BB “70/30”
BB “70/30”
BB NPH
BB NPH
BL Aspart
BL Aspart
BL Aspart
5
BD
BB “70/30”
BB “70/30”
BB “70/30”
BB NPH
BB NPH
BL Aspart
BL Aspart
BL Aspart
6
AD
BB “70/30”
BD Aspart
BD Aspart
BD Aspart
BD Aspart
BD Aspart
BD Aspart
BD Aspart
7
BT
BB “70/30”
BD Aspart
BD Aspart
BD Aspart
BD Aspart
BD Aspart
BD Aspart
BD Aspart
8
4AM
BB “70/30”
BD Aspart
BD Aspart
BD Aspart
BD Aspart
BD Aspart
BD Aspart
BD Aspart
Algorithm for Treatment of Type 2 Diabetes
Diet and Exercise If A1C > 6.5% Monotherapy or Combination Therapy Adequate Not adequate Other Oral Combinations Adequate Follow-up q 3 mo Not adequate Oral Agent Plus Insulin at Bedtime (Glargine or NPH) Adequate Follow-up q 3 mo Not adequate Split-Mixed Insulin or Lispro or Aspart qac + Glargine or NPH qhs
Follow-up q 3 mo
Validation Strategy
De-identified blood glucose and medical records of patients with diabetes on a variety of regimens will be obtained from the Endocrinology Clinic, at Walter Reed Army Medical Center The results of the CADS recommendations for each patient and scored according to the appropriateness of the recommendation by independent PCPs.
Testing Phase
• PCPs will be randomized into a CADSenabled and usual care group • The primary outcome measures will be improvement in A1c over a 6 month period • Secondary outcomes include:
– Medication usage – Adverse events – Usability
Summary
• We have designed a CADS system which integrates goals of treatment, blood glucose data, current regimen, and laboratory data into a set of recommendations for treatment of DM • The system is customizable on an individual, group, and/or enterprise levels • Preliminary coding of the system has been done and testing will begin this summer
Questions
CADS DEMO http://ndjh.lifeclinic.com/
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