Use of Decision Support Software To Titrate Multiple Daily Injections Yielded Sustained A1c Reductions After 1 Year
European Association for the Study of Diabetes Annual Meeting
Andrew Rhinehart, John Clarke, Robby Booth
Multiple issues continue to plague diabetes management:
- High insulin attrition rates1
- Ineffective doses of insulin and insufficient dose adjustments2
- Insufficient adult endocrinologists to manage all the people with poorly controlled diabetes3
- High percent of patients with an A1C above 9%, which has changed little in the last decade4,5,6
In an attempt to remedy these issues, numerous clinical decision support products (apps and software) promoting insulin dose titration have been FDA cleared in the last year. Glucommander by Glytec is an FDA-cleared and CE marked class II medical device that was utilized as the Clinical Decision Support Software (CDSS) for insulin dose titration in our study. Its efficacy has been well documented and will be used to treat over 100,000 patients during 2017. CDSS provides integrated and personalized diabetes therapy management intended to assist healthcare providers with subcutaneous insulin dose titration by analyzing blood glucose data and calculating patient-specific insulin recommendations for basal, mealtime, and correction doses in conjunction with integrated cellular and Bluetooth enabled blood glucose meter partners.
Standard methods for manual titration of insulin typically follow a one-size fits all approach with a weight-based or fixed unit starting dose that increases a fixed amount at set time intervals.9,10 It is also unclear as to how frequently patients need dose titrations to sustain improvements in A1C. A literature review identified no specific evidence to help guide providers in regards to how frequently to review glucoses and titrate insulin after a patient has achieved glucose control. The typical practice is to see a patient back for follow-up every 3-4 months once A1C is controlled.9,10
The intention of our study was to show the robust and sustained A1C reductions that can be achieved with the use of CDSS to titrate multiple daily injections (MDI) and at the same time, fill a research gap in regard to the needed frequency of insulin dose titrations once a patient has achieved their target A1C.
METHODS AND MATERIALS
The study comprised of 74 patients with either type 1 or type 2 diabetes, requiring insulin, ages 18 and above, non-pregnant, able to self-manage their diabetes (finger sticks, insulin injections, treatment of hypoglycemia) and willing to test blood glucoses 4 times a day.
|Average Age (years)||56.2||14|
|Male, n (%)||43 (58%)|
|Average Initial BMI (kg/m2)||31.9|
|Average Final BMI (kg/m2)||33.3|
|Change to Average BMI (kg/m2)||1.4|
|Average Initial Weight (kg)||93.8||24|
|Average Final Weight (kg)||96.0||25|
|Change to Average Weight (kg)||2.2|
|DM Type 2, n (%)||58 (78%)|
|DM Type 1, n (%)||16 (22%)|
|Average # Years with DM||16||12|
STUDY TREATMENT AND ASSESSMENTS:
The CDSS was initially ordered by the provider at the time of an in office visit via an order set which included the insulin(s) to be used, the starting insulin dose(s) (either weight-based or custom doses), the target glucose range (100-140 mg/dl), and the initial dose titration interval (3 days). All blood glucose data was collected using the Telcare cellular-enabled glucose meter, which was able to provide near real-time glucose results into a secure cloud environment that then interfaced into the CDSS. After initiation, the nurse would utilize the CDSS daily during workdays to scan for low blood glucose readings and adjust insulin doses when the patient was due a titration. After the initial three-day titration, the CDSS would recommend new insulin doses as well as a new dose titration interval of 3, 7, 14, or 28 days based upon the patient’s glucose control. Updated insulin doses were sent to the patient, either on the display of the patient’s cellular-enabled glucose meter or via a mobile text message. If the patient had no cell phone, emailing or calling the patient was an option.
During treatment with CDSS, A1C decreased from a baseline average of 10.3% to 8.0% at 3 months, 8.0% at 6 months, 8.3% at 9 months and 7.8% at 12 months. The baseline-to-final A1C decrease shows a P <0.00001 by paired T-test. Hypoglycemia was infrequent throughout (see table). Out of 37,622 BGs, the average number of BG tests per day was 3.0 during the first 3 months and 2.5 during the final 3 months. The median time for patients to achieve three consecutive days with their average daily BGs <180 mg/dl was 7 days. As a backup check the mean BG was tested also; it declined from 214 mg/dl to 162 mg/dl with P <0.00001. This drop is free from Regression-Toward-the-Mean. After the first three months of treatment, the software recommended a change to the patient’s insulin dose an average of every 57 days.
|Number of Patients||74|
|Mean # Days Until Day-Averaged BG <180 mg/dL for 3 Consecutive Days||7|
|% BGs <3 mmol/L (54 mg/dL)||0.37% (139)|
|% BGs <2.22 mmol/L (40 mg/dL)||0.05% (19)|
|Number of BGs||37,622|
|Average Initial TDD (units/kg)||0.66||0.34|
|Average Final TDD (units/kg)||0.91||0.52|
|Average Initial % of Basal Insulin||50%|
|Average Final % of Basal Insulin||31%|
|Average Time Between Dosing Adjustments After 3 Months||57 Days|
The sustained use of Glucommander™ Outpatient CDSS is effective at treating all diabetes patients not at goal with minimal minor hypoglycemia and no assisted hypoglycemia. CDSS that provides personalized patient recommendations can substantively improve clinical outcomes and assist providers in getting more patients to goal using insulin.
CDSS was shown to be safe, effective and sustains glucose control over 12 months. The current practice of 3-6 month follow-up of a patient after achieving glucose control is insufficient to maintain that control and may put a patient at risk for hypo or hyperglycemia. Our study would suggest that remote glucose monitoring accompanied by insulin titration every 6-8 weeks can maximize and maintain adequate glucose control. Prospective randomized clinical trials are ongoing to compare the safety, efficacy and cost of Glucommander versus other outpatient diabetes management methods. Larger prospective randomized clinical trials are needed to confirm these findings.
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