Scripps Digital Diabetes: Glucose Values As A Vital Sign
Project Researcher: Addie Fortmann, Ph.D. – Scripps Whittier Diabetes Institute
Individuals with type 1 diabetes (T1D) comprise a small proportion of annual hospital admissions; however, when hospitalized with critical medical conditions, blood glucose values can fluctuate dramatically, quickly putting these patients at risk for complications of severe hypo- and hyperglycemia. Optimally, in an acute care setting blood glucose monitoring should occur continuously, similar to the observation of other vital signs such as heart rate, oxygen levels, and blood pressure. Continuous glucose monitors (CGM) alert people with diabetes that glucose values have reached, or are trending toward dangerous ranges.
Our study will examine the value and utility of the CGM in the inpatient environment. Specifically, we hypothesize that use of CGM will result in fewer dangerous episodes of severe hyper- and hypoglycemia and improved satisfaction with care among hospitalized patients with type 1 diabetes. The proposed research has the potential to improve the safety and outcomes of the most critically ill individuals with diabetes. This project is forward-thinking in that it is patient-driven; Scripps patients with T1D provided the impetus for this project, based on their experiences with glucose management in the hospital, and have contributed significantly to protocol development. This study will provide valuable information on the ability of CGMs to improve important outcomes and satisfaction with care among individuals with T1D in the hospital.
We hypothesize that the percentage of patient-days with average glucose in the target range (70- 180 mg/dL) among patients with type 1 diabetes utilizing the CGM will be higher compared with historical baseline data. We predict that the rates of hypoglycemia (<70 mg/dL) and hyperglycemia (>180mg/dL) among patients with T1D utilizing the CGM will be lower compared with historical baseline data. We will also examine the acceptability and feasibility of using CGM in the hospital environment from patient and provider perspectives.
All patients with T1D admitted to Scripps Hospital La Jolla or Scripps Mercy Chula Vista who meet study criteria will be invited to enroll in the proposed research until recruitment goals are reached (N=100). Upon admission, the emergency department, admitting nurse, or attending physician will notify the inpatient glucose management team [(APN and/or certified diabetes educator (CDE)] of potentially eligible patients with T1D. The APN or CDE will then screen the patient. We have selected only minimal exclusion criteria in order to obtain a sample that is representative of hospitalized patients with T1D, and in turn, enhance the generalizability of the findings. Once enrolled, participants will have CGM sensors placed and calibrated appropriately within 24 hours of admission by a member of the inpatient glucose management team. The CGM will remain in place, and the patient will be followed by the diabetes APN for glucose management for the duration of the hospitalization. Through close collaboration with the attending physician and other care team members, the diabetes APN will use a standardized glucose management algorithm, which incorporates CGM data and validation point-of-care (POC) testing values, to achieve optimal management of blood glucose. Wireless communication will allow for assigned study personnel to view CGM values at real time and also be alerted by alarms set by specifications above. Insulin adjustments will be individualized based on the patient’s clinical scenario. Communication between glucose management team, nursing staff and monitoring physician may take place more often if trends towards hypoglycemia or hyperglycemia are visible.
Primary outcomes of rates of hypo- /hyperglycemia among patients with T1D will be compared with historical controls from the same hospital in the previous year. Self-report surveys will be administered prior to discharge to assess satisfaction with blood glucose control during the hospitalization, and patient’s perceptions regarding acceptability and feasibility of the CGM (e.g., comfort, sleep interference, desire for continued use). After discharge, 2 focus groups (of 6-10 participants each) will be conducted to ascertain more in-depth, qualitative information regarding patients’ perceptions of the CGM. Lastly, key informant interviews will be conducted to ascertain provider (staff nurses, hospitalists, APNs) satisfaction and recommendations based on their experience.
Update on 5-4-17
We have selected two cases to provide a real world “snapshot” of The Scripps Digital Diabetes study progress to-date. These cases were selected by our clinical implementation staff to demonstrate the value that is added by a Continuous Glucose Management (CGM) device in inpatient glucose management, and the patients’ experiences and perceptions of CGM use while in the hospital.
A 62 years old female with type 1 DM for over 30 years with a history of retinopathy and neuropathy was admitted for a quadruple coronary artery bypass. At home, her glucose was well-managed with a Paradigm Insulin pump and a Dexcom CGM device and recent A1c level was 7.4%. The patient was placed on the CGM Study after transitioning off the hospital intravenous infusion and placed on the standard insulin subcutaneous protocol.
The following subsequent events and interventions demonstrated the benefits of the CGM to assist with managing patient’s blood glucose (hyperglycemia alert > 200 mg/dL and hypoglycemia alert < 90 mg/dL):
Post Op Day (POD) 1: RN received a call four times (8pm-5:15am) with high alert of BG > 250 mg/dL and administered Humalog (2 units) twice at 11:34pm and 3:23am.
POD 2 am: CGM alert BG > 250 mg/dL, call staff nurse early at 6:45am requested extra 10 units Humalog which staff nurse received order from consulting Hospitalist and given the 10 units Humalog at 6:53am.
Together with the patient’s endocrinologist the CGM trends and total insulin doses (Lantus/Humalog) for the previous 24 hours were analyzed with recommended increases in Lantus and collaboration with the hospitalist for Humalog boluses with meals and overnight correction.
POD 3: With the assistance from CGM trends in addition to point-of-care (POCT) BGs, adjustment of the insulin therapy continued. Prior to dinner, CGM alert BG trending was noted below 100 mg/dL with POCT BG at 84 mg/dL. Nurses intervened with juice but patient precluded adequate treatment. Rapid intervention orders were obtained from the hospitalist to give D50W 25 mL x1 intravenously. With timely administration of reversal agent, a hypoglycemia event was averted. Overnight, no high or low alerts noted with BG 151 mg/dL (9pm) and 146 mg/dL (11pm).
POD 4: Discharge day – POCT BG 139 mg/dL (5:20am) and 148 mg/dL (7:10am). The patient resumed her own insulin pump at 9:30am in anticipation of discharge.
Overall, patient’s satisfaction with the use of CGM for her glucose management was rated as positive (9 out of 10) with Fair in the rating of her blood glucose control, especially since she just received a complex surgery that cause tremendous stress on her body. Patient found the CGM to be another way for her to participate in her care and to address her concerns in a timely manner. Her husband was also appreciative of the attention to her glucose management.
We had the opportunity to place a DexCom CGM on a post-partum patient during a 4-day post-partum hospitalization. Although the post-partum unit was not initially included in the scope of study, an IRB exception was obtained in order to include this patient as the research staff recognized the clinical benefit that could be obtained by having continuous blood sugar data available. During the 4-days that the patient was wearing the CGM, there were 8 notifications to the telemetry staff between the hours of 7:30PM and 6:30AM, when staff otherwise would not have been obtaining a point of Care blood sugar check. These were all instances when the patient was experiencing low blood sugar (though not necessarily hypoglycemia of BG < 70mg/dL) which would not have otherwise been detected. The patient refused our pro-active treatment of glucose gel, but instead preferred to treat with her own remedy of food (crackers, juice, etc.). However, she most likely would not have been aware of the need to eat, if it weren’t for our notification because of the CGM data.
When queried about her satisfaction related to wearing the CGM while in the hospital, the patient gave us an overall positive score of 9.5 out of 10, with 10 being “completely satisfied”. The one complaint was occasionally being woken up for additional BG testing due to concerning trends, in her case low BG. However, she said she preferred management with sub-cutaneous insulin and the CGM data, as compared to being on the IV insulin drip which may provide tighter control but requires every 1-2 hour testing even when in good control. Overall, she stated that she would definitely recommend the CGM to other hospitalized patients.
Update on 4-27-16
Currently all start-up activities have been completed – i.e., protocol is IRB-approved, research staff is trained, technology is integrated within the hospital, and provider/hospital staff education is complete. So, we are now ready to enroll – expect the first patient to be enrolled any day now. This is a closed trial as it identifies patients who are currently in the Scripps Hospital system.
Update on 9-1-16
Study procedures have been piloted with 40 patients to-date at a separate hospital site, and our protocol has been refined to ensure feasibility and acceptability from all perspectives. Based on feedback, we have revised our consent form (and obtained IRB approval) to permit patient participation in other trials that do not have the potential to interfere with the proposed research. Additionally, a comprehensive, HIPAA-compliant data tracking system has been built in Research Electronic Data Capture (REDCap), and the research team has been trained to code and enter data for analysis. All patient- and staff-reported data from pilot participants have been entered and database modifications have been made to ensure accuracy of data management and eventual analysis.
At the target hospital, n=9 T1D patients’ charts have been reviewed for possible enrollment; however, 8 were not approached for screening due to short length of stay (i.e., < 48 hrs) and/or other factors that deemed them ineligible for participation (e.g., on IV insulin drip). The remaining patient was successfully screened and enrolled as the first official study participant on 8/25/16. Based on the short lengths of stay observed to-date with the other patients, we have worked with the Scripps Health Project Management Office to produce daily, automated (“real time”) lists of potentially eligible patients. These lists will allow our research team to identify patients earlier in their hospitalization. Our research team will also consider adding a neighboring hospital site (of similar patient demographic) to the sampling pool should this be needed to meet enrollment targets and satisfy study objectives. However, based on the new automated lists, the average number of potentially eligible hospital patients to approach is 4/day, so we anticipate meeting recruitment goals without issue.