The Project


Controlling Blood Sugar Levels A Green Belt Project

A Green Belt Class from Georgia Tech University
October 2014 - Current

Phase 1 & 2 are presented Below Phase 3

You may find it better to drop down to Phase 1 first, if you want the full flow of the project. 

Phase 3 December 2015
Operational Definition
Improvement Strategy

From Brainstorming (Added Emphasis on Controlling Variation)
1. Continue once daily morning reading after 8 hr overnight fasting
2. Conduct one A1c test per month and start monthly A1c tracking
3. 15th -2oth day of month
4. Evaluate Fitbit Challenger as a method to measure all forms of activity
5. Evaluate Fitbit Challenger as a method to add a measure
6. Determine a seven day average target for carb intake
7. Use next day allowable calculation to maintain target average
8. Modify tracking tool for carb intake to calculate a daily level based on carry over and current target for carb intake
9. Modify tracking tool for carb intake to manually calculate before dinner carb level to allow voluntary control to specific carb level daily target and establish daily target
10. Move evening exercise routine to morning / research supports it maybe effecting sleeping habits
Phase 3 Cost

Prime Test Strips         $19.56
Relion A1C Test           $12.43
               Total            $31.99

Fitbit Credit               $141.03        Phase 2 this was considered a flop

Phase 3 Carb Count Cart & Grocery List

Carb Counting Sheet & Grocery List
Phase 3 Redefined Goals

1. Track carb intake daily and continue to develop the carb intake tracking form
2. Maintain 7 day average carb intake below 100 grams
3. Calculate carry over carb level to determine 7th day target
4. Adjust carb intake up or down to regulate weight to ideal weight target
5. Adjust carb intake up or down to regulate 7 day average reading to 100 mg/dL
6. Maintain 7 day average glucose ready after 8 hour fast below 100 mg/dL
7. Maintain a monthly A1c reading below 5.7 %
8. Maintain a minimum exercise level at or above 36 miles per week

Phase 3 Fitbit Evaluation / Results

1. Evaluation of the Fitbit wrist band showed it as an unreliable tool to monitor sleep
     If you lay still or get out of bed and setup still and watch TV it records you as sleeping
2. Evaluation of the Fitbit wrist band showed it as an unreliable tool to activity level
      The Fitbit steps and distance calculation proved to be off by as much as 50%
        When validating running on a 1 ½ mile trail the calculation for steps had a stride length beyond           what is reasonable of maintaining. As a marathon runner arm swing and stride was most likely           softer than the Fitbit could use for calculations and consistent pickup

Phase 3 Data

Carbohydrate Six Sigma Tracking Table
Phase 3 Six Sigma Data

Phase 3 Six Sigma Green Belt Data
Phase 3 Issues with morning Repeatability Test

    Continued concern of using daily blood sugar readings comes from repeatability testing over a short window of time for morning blood sugar levels:

Morning sequence 12/17/2014
Time Reading Task
4:30 AM 104 mg/dL Right after wake-up
4:45 AM 99 mg/dL Got ready for work
5:00 AM 94 mg/dL After some floor exercises
5:15 AM 93 mg/dL Took luggage to the car

Phase 3 Results - Blood Sugar Cycle

    Attached are two tables used to address the relationship of peaks and valleys between carb intake and blood sugar reading.  Peaks are points when carb intake levels goes above 105 gr and valleys are when carb intake levels drop below 90 gr. The associated peak or valley of blood sugar level reading will define the cycle time for the effect of specific carb intake.  Not perfect but it shows an average cycle that says you will see the effect of carbs most likely the 2cd morning.  Once additional variables are controlled better additional confirmation is required.
Evaluating Peaks in Carb Levels
Evaluating Valleys in Carb Levels
Phase 3 Simple versus Complex Carbohydrates

    By further study of high and low reading points and overlaying the 2 day cycle you can see a trend between simple and complex sugars in the makeup of carbs.  High sugar days will have a lower 2cd day blood sugar reading.  Most likely because they break down quickly and may account for higher next day readings. As a result the daily carb tracker has been modified to include daily sugars to allow more detail evaluation in an attempt to better predict readings before hand.
Total Sugar versus Total Carbohydrate Intake
Phase 3 Observations

1. The sigma value increased through the phases; 1.50, 1.65, to 1.83. Primary assumption is better control of carb intake level with averaged decreasing; 120g, 119g, to 100g.
2. Comparing high and low spike in blood sugar levels to high and low spike in carb intake reveled a 48 hr blood sugar cycle. The affect of todays carbs will only have a minor affect on next morning but will have the primary affect on the second morning. Some variance was seen in the cycle from next day to third day. Other factors are still to be explored.
3. Disruptive sleep patterns are noted to have negative effect on blood sugar levels.
a. I found when I wake in the middle of the night I can’t get back to sleep.
b. Using an over the counter product “Peak-Life Somnapure Natural Sleep Aid”
c. I can fall back to sleep quickly and have no noticeable effects the next day.
d. From a subjective standpoint I feel it has improved my morning blood sugar level. Going forward I need to.
e. Next step is to quantify the affect of a late night sleep aid.

Phase 3 Conclusions

1. The carb to blood sugar cycle is approximately 48 hours. Obviously there are numerous factors that play a role. However, to understand the effect of carbs today you need to look at the second morning blood sugar level. This trend was seen numerous times through the data by spiking carb input and looking for the blood sugar reading spike. 

2. Planning ahead for an event like holiday meal, work team lunch or even night out will allow maintaining consistent carb intake levels. Things like having a zero carb breakfast or lunch can smooth out the dinner spike or a low carb day before the holiday event will hold the blood sugar levels down. Carb intake 
spikes must be eliminated or better controlled to hold blood sugar levels down.

3. Utilizing a late night sleep aid can better control the affect of sleep patterns during evaluation (Peak-Life Somnapure Natural Sleep Aid).

4. Understanding the 48 hour cycle of blood sugar intake will allow evaluating the affect of complex and simple sugars in carbs.

Phase 2 November 2014
Operational Definition 
Trial Phase

    Phase 2 is considered a trial phase for a prototype process that fits into a daily routine. It requires simplification of Phase One process but still gives the opportunities to test hypothesis before going into pilot or operational phase.

Phase 2 Plan
*Conduct a cause & effect study
*Simplify process for collecting and recording daily carb intake
    *See “Revised Data Collection Form”
    *Utilize only the morning reading after fasting
    *Interval data during the day was considered non-value added
*Observe next morning, second day, 3 day average and 7 day average readings
    *Next morning blood glucose readings can not be predicted with just carb intake level and run data
*Build the collection form so it can also be a weekly shopping list
*Conduct a test with 5 consecutive days below 100 gr carb intake
*Conduct an A1c test
*Conduct a test to determine the repeat-ability of blood sugar reading process
    *Use 4 fingers and one alternate site with 3 tests each to provide 15 readings for comparison
*Conduct a control test to determine meter base line


Phase 2 Costs
Prime Test Strips     $19.56
RELION A1c             $12.43
Control Solution       $13.10
Fitbit Charge          $141.03
Reader Battery          $4.75
RO Lancets               $4.06
REL Swabs                $1.09
                  Total   $196.02

Cause & Effect Study (Fish-bone Analysis)

Phase 2 Data

Phase 2 Data Review

Results From Home A1c Test


A1c blood test was taken with an off the shelf kit 
The test was conducted 11/16/2014

A1c blood test result was 5.5 percent

A1c blood test was below the 5.7 percent lower limit for pre-diabetes

Note: The A1c blood test is an average over the last 90 days. The result is weight as 50% last 30 days 25% 30-60 days and 25% 60-90 days 

Repeat-ability Test Part 1

Repeat-ability Test Part 2

Control Test 
Evaluate Repeat-ability of Meter

Seven Day Average Tracking


Data Collection Form for Phase 2
with Grocery List

Phase 2 Results

    Fifteen readings at or above 100 mg/dL over a 30 day period / readings at or
above 100 mg/dL are considered defects
    Zero readings above 125 mg/dL with the maximum reading of 112 mg/dL
11 point drop from Phase 1 maximum reading
    Average reading dropped below 100 mg/dL to 99.3 mg/dL compared to
100.17 mg/dL for Phase 1
    A1c reading was at 5.5%, below the 5.6% pre-diabetic threshold
    Variation in both rate of change during testing and differences in test site
poses concerns on daily test reliability
    Improved data collection sheet for daily readings proved very helpful along
with the grocery shopping list

Phase 2 Observations

    Prime meter is repeatable but the human body is very sensitive and reacts by
increasing blood sugar levels rapidly questioning the value of mid-day reading
    How you sleep and take the morning blood glucose reading is critical to
morning reading (activity quickly raises blood glucose readings)
    A1c test is not sensitive to time of day, activity level or single day carb intake
and may be the best alternative for blood glucose monitoring for those not actively using insulin
    The A1c test is slightly less costly than daily readings and much less time
consuming performing once monthly test versus daily tests

Phase 1 October 2014
Improvement Case

    Sugar diabetes is a family trait and had a major effect on my mother's life. Ultimately it was directly related to the health issues that lead to her death.
    In order to prevent those same limitations on my life I've chosen Type 2 Diabetes as something I want to be able to address with minor effect on my life style. My goal is to use a healthy lifestyle to control my blood sugar levels as long as possible.

Problem Statement

    Four years ago at my annual physical my doctor said my blood sugar levels were elevated and I was classified as a pre-diabetic.
    After trying minor adjustments to my diet and losing some weight I went back for my annual physical and my doctor said I was a Type 2 diabetic. My blood sugar levels had climbed over 126 ml/dL and my physician asked if I was ready to try medication for better control. I requested some time to do some research and make an informed decision on what I wanted to do.
   By my next visit I learned to better control my carb intake and my blood sugar levels had dropped to pre-diabetic levels. However, the battle was just beginning to permanently change my life style.
    This last year my blood sugar levels had climbed back to the Type 2 diabetic level and I was unable to sustain my improvements. For my visit July 26, 2014 my Blood Glucose level was 136 ml/dL, with and A1c of 5.7%. It was time for a scientific approach for sustained improvement. 

Defect Definition
 
  • Defect is any morning blood glucose reading above 100 ml/dL
    • Based on readings taken first thing in the morning after a minimum 8 hours fasting
Project Goals

  • Maintain average daily blood sugar level below 100 mg/dL
  • Maintain maximum daily blood sugar level readings below 120 mg/dL
  • Maintain a monthly A1c level at or below 5.6%
  • Understand the effect of carb intake on blood sugar levels
  • Develop a process to effectively and efficiently track and control blood sugar levels
Project Research
Research for the project provided the following guide:
  1. Normal Levels have a fasting Blood Sugar level between 70 and 99 mg/dL
  2. Normal A1c level below 5.7%
  3. Pre-diabetes Blood Sugar level between 100 and 125 mg/dL
  4. Pre-diabetes A1c level between 5.7% - 6.4%
  5. Diabetic Blood Sugar level at 126 mg/dL or greater
  6. Diabetic A1c level at 6.5% or greater
Phase One
Operational Definition
Discovery Phase
Design a data collection spread sheet that collects:
  • Glucose Readings at various times during the day
    • Morning, After Lunch, Before Dinner, After Dinner and End of Day
  • Use the readings to calculate changes in Glucose Readings during the day
  • Collect carb level intake in Grams for morning, lunch, dinner and evening
  • Tracking running data by date
  • Collect relevant notes by day
  • Track weight by day
Use the data collection system to determine correlation between blood sugar levels and the following attributes:
  1. Carb level intake
  2. Running distance
Collect data over a 30 day period

Phase One Data


Phase One Project Cost
Prime Glucose Meter           $17.64
Prime Test Strips                $19.55
RO Lance Device                  $6.34
RO Lancets                          $4.06
REL Swabs                          $1.09
                              Total    $48.68

Phase One Results and Observations


Phase One Results

  • Twelve readings at or above 100 mg/dL over a 30 day period / readings at or above 100 mg/dL are considered defects
  • Zero readings above 125 mg/dL with maximum reading of 123 mg/dL
  • Next day blood sugar reading does not directly follow day before carb intake
  • The 3 day blood sugar average trend reading follows the 3 day average trend carb intake pretty close
  • When running distance of 9 miles and greater blood sugar levels dropped 4 out of 4 time for the 24 hour period, however blood sugar levels did not follow running trend directly
  • Runs of 6 miles and less did not show a significant effect on blood sugar level
Phase One Observations
  • Exercise over 6 miles had a short term affect of elevated blood sugar levels / contrary to expectations
  • Longer runs are likely to show a downward affect on blood sugar levels over a 24 hour period but no significant decrease was seen
  • Blood Glucose readings do not correlate directly with carb intake levels or exercise level over a 24 hour period
  • Blood glucose readings did appear to follow carb intake levels when using a 3 day average
  • Phase 1 data collection process was very complicated and took to much time to be sustainable
  • When grocery shopping is was hard to keep up with what to purchase to best sustain low carb intake
Phase 2 will be published 3/15

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