Introduction
Methods
Results
Level | Ref. | Materials | Target range and monitoring interval | Design | Result |
---|---|---|---|---|---|
I | [23] | 50 patients, nine-bed medical ICU, 72 h of ICU stay | TR: 80–110 | Prospective, five months, RCT | Median BGL and HGI were significantly lower in the CDSS group [BGL 106; HGI 7.2] than in control patients [BGL 133, p < 0.001; HGI 29, p < 0.001]. One hypoglycemic episode was detected in the CDSS group but none in the control group. Sampling interval was significantly shorter in the CDSS group [117 min vs. 174 min; p < 0.001]. Thirty out of thirty-four nurses answered the question of whether the algorithm could be applied in daily routine in the affirmative. |
M: NM | |||||
[24] | 40 patients with diabetes mellitus and scheduled cardiac surgery, Cardiothoracic ICU. Operation time and first 9 h in ICU | TR: 90–150 | Prospective, RCT | The mean BGL (147 vs. 126, p < 0.01) and the mean time to capture range (171 min vs. 40 min, p < 0.001) decreased during the ICU stay. Patients in the CDSS group spent more time in the desired range during both the intraoperative phase (49 vs. 27%, p < 0.001) and the ICU phase (84 vs. 60%, p < 0.0001). There were no statistical differences between groups in the number of hypoglycemia episodes. | |
M: 15 min–4 h | |||||
[8] | 484 patients, 18-bed medical-surgical IC, ≥24 h in ICU | TR: 72–126 | Prospective, 10–6–10–4 weeks, before protocol–paper-based–randomized between paper-based or CDSS–paper-based protocol | In the paper-based period, 29% of the samples occurred with optimal timing; during the second period, this increased to 35.5% for paper-based and to 40.2% for computerized protocols. In the third study period timeliness scores reverted to the first period rates. The same occurred for late sampling and insulin dose compliance. For the second study period, the time that a patient’s BGL fell within the target range improved for both the control (52.9%) and computerized (54.2%) groups compared with the first study period (44.3%), the third period (42.3%), and before TGC (22%). | |
M: 15 min–3 h | |||||
II | [9] | 552 trauma admissions, 31-bed ICU | TR: 80–110 | Retrospective, 4 + 3 months, before/after | Median number of BGLs was 18 in control vs. 12 (4–54) in intervention group (p = 0.27). Mean BGL was lower (116 vs. 12; p < 0.001), and median BGL measurement interval decreased (2.79 vs. 2.14; p < 0.001). Percentage of range BGL increased (41.8 vs. 34.0%; p < 0.001), hyperglycemia and hypoglycemia frequency decreased (12.8 vs. 15.1% and 0.2 vs. 0.5%; both p < 0.001), and within 12 and 24 h more patients reached normalization (69.7 vs. 62.1%; p = 0.47 and 79.8 vs. 77.7%; p = 0.88). For post-initiation, computerized protocol entries compliance to protocol’s recommendations was 98%. |
M: 2 h in manual and 1–2 h in computerized protocol | |||||
[22] | 1,080 patients, four ICUs | TR: 80–110 | Prospective, 22 months, controlled | Compliance with eProtocol-insulin advice was 91–98% among the four ICUs. Compared with the simple guideline, eProtocol-insulin BGLs in target increased from 21 to 39% (p < 0.001) and mean BGL decreased from 142 to 115 (p = 0.001). Number of measurements and patients with at least one hypoglycemic event did not change significantly. | |
M: 15 min–2 h in paper-based protocol and 1–4 h in computerized | |||||
[10] | 2,398 patients, progressive care unit and mixed medical-surgical ICU. | TR: 80–110 | Retrospective, 17 months, Observational, 3 + 3 before/after | 61% of BGL were in target range, mean BGL was 106, and hypoglycemia frequency was 0.4%. After a hypoglycemia event the mean interval until next measurement was 26 min, and the mean next BGL measurement was 106. Achieving the target range (with mean BGL of 98) required 6.9 h. Percentage of measurements <110 increased from 32 to 52% due to intervention (p < 0.001). The frequency of hypoglycemia decreased from 0.5 to 0.4%. | |
M: 15 min–2 h | |||||
[25] | 97 coronary artery bypass graft patients, six-bed Cardiothoracic ICU, first 48 h after surgery | TR: 80–120 | Retrospective, 5 + 5 months, before/after | There was a decrease in mean BGL (in first 48 h) from 154 (only type 2 diabetic patients included) to 118 in type 2 diabetic patients and 116 in non-diabetic patients (p < 0.0001), in percentage not in target range within 48 h (26 vs. 4.6% and 3.0%, p < 0.0001), in mean time to capture the target range (22.1 vs. 8.7 h and 5.9 h, p < 0.0001) and in hyperglycemia index (41.34 vs. 12.97 and 8.46, p < 0.0001). The hypoglycemia rate was not significantly increased after the intervention (1.14 vs. 1.42% and 1.94%, p = 0.26). | |
M: 15 min–2 h | |||||
[26] | 129 + 128 trauma patients, ≥72 h in ICU | TR: 80–130 | Retrospective, 6 + 6 months before/after | Significant reduction in mean BGL and total infection in all LOS categories were demonstrated after intervention. However, case mix adjusted mortality was significantly higher after the intervention. The percentage of hypoglycemic patients did not change (31 vs. 32%). | |
M: not mentioned | |||||
[15] | 351 patients, 21-bed surgical ICU, first five days in IC | TR: 80–110 | Retrospective, 32 + 49 days before/after | The computer-based protocol reduced time from first BGL measurement to initiation of insulin protocol, improved the percentage of in-range BGL (29.3 vs. 37.7%; p = 0.006), and patients on IIT for ≥24 h were on average 116 min more in target range (p = 0.029). The overall mean BGL for the first 5 days of IC admission were non-significantly lower in post-intervention group (129 vs. 134). Hypoglycemia was rare in both groups (0.2% of measurements). | |
M: 1 h in manual protocol and 1–2 h in computerized protocol | |||||
[11] | 891 patients, 16-bed ICU, at least 24 h in IC | TR: 97–128 | Retrospective, 9 + 15 + 5 months before/after | The mean BGL decreased from 131 before intervention to 119 thereafter and then to 112 after the first revision. The proportion of values <144 increased from 69 to 81% and then to 89%. One episode of hypoglycemia was observed before the intervention, 13 after intervention and then six after revision. The hit counter added to the calculator after the end of study showed the monthly use was 1,175 hits on average. | |
M: 30 min–4 h | |||||
IV | [27] | 661 patients, 16-bed ICU | TR: 97–128 | Prospective, 12 months, observational | Mean BGL was 121. There were 34 episodes of treated hypoglycemia 11 of which were on an IIT. There were two troughs in the time of data entry that corresponded with staff handover. There was no evidence of diurnal variation in BGL. |
M: 30 min–4 h | |||||
[17] | 2,800 patients, three ICUs (surgical, neurosurgical and cardiothoracic). | TR: 72–135 | Prospective, 30 months, observational | Patients were on GRIP-ordered pump rates 97% of time. Median measurement time was 5 min late (IQR 20 min early to 34 min late). Hypoglycemia was uncommon (7% of patients for <63; 0.086% for <40). Median time to capture target range was 5.6 h (0.2–11.8) and maintained for 89% (70–100) of the remaining ICU stay. The glucose variability was 22 (14.4–31.5). The frequency of measurements was 5.9 (4.8–7.3) per patient-day or once every 245 min. | |
M: 30 min–12 h | |||||
[28] | 179, patients, ten-bed mixed medical-surgical ICU | TR: 81–135 | Prospective, 3 months, observational study | Mean BGL decreased from 166 without protocol to 138 with the final protocol implemented by a CDSS. BGLs were measured a total of 1,854 times in 179 ICU admissions during 553 ICU treatment days. The median BGL was 126, and 53.1% of BGLs were within the target range. One episode of hypoglycemia occurred (0.5% patients or 0.05% measurements). | |
M: 30 min–24 h | |||||
[29] | 50 patients, 22-bed ICU, ≥24 h on mechanical ventilation | TR: 80–110 | Prospective, 6 month, observational study | Median time percentage in target range was 23%. BGL was 50% of time in the range 112–144. Median proportion of time spent in hyperglycemic range 180–200 and >201 was 2 and 1.4%. There were 28 hyperglycemic episodes including those of 15 (30%) patients treated with IIT protocol. Median time to capture the target range was 10.5 h. Median of 47% of sampling were not taken within the time frame stated in the protocol. Hypoglycemia occurred 14 times and in five (10%) patients. | |
M: 15 min–4 h | |||||
[7] | 5,080 IIT run over 120,683 h IIT. | TR: 100–140 | NM, observational | The mean BGL reached <150 in 3 h. The prevalence of hypoglycemia was 2.6% among all runs. All episodes of hypoglycemia were recognized within 20 min. The mean of all BGL <60 was 49 and the follow up value in an average of 33 min was 83 (p < 0.001). No clinical symptoms due to hypoglycemia were reported. | |
M: 20 min–2 h | |||||
[16] | 179 patients, 12-bed surgical ICU. | TR: 72–135 | Prospective, 4 months, observational | Severe and mild hypoglycemia rates were 0.6%, and 11.2%. In patients staying >24 h, time to capture target was 5.7 h and hyperglycemia Index was 17.3 mg/dl. Median time percentage for BGL in target range was 78% with median BGL of 88. Mean BGL change in the first 24 h was −21. After 24 h, mean BGL was 121. Nurses rated program as easy to work with and as an improvement over the paper protocol. | |
M: 30 min–12 h | |||||
[21] | NM, surgical ICU | TR: 100–150 | NM, observational | There was a significant improvement in glycemic control. The benefits to the participating institution were increased awareness of the importance of improving BG control, decreased calls to physicians, reduced need for sliding-scale insulin injections, increased nursing satisfaction because of fewer calls to physicians for insulin adjustment, and increased physician satisfaction because of improved BG control and fewer interruptive phone calls. | |
M: 20 min–2 h |
Ref. | Type of protocol | Type of system | Consultation mode for: pump/next measurement | Users before/after new system | Evaluation of | Evaluation of usage, usability and satisfaction | Short description of CDSS |
---|---|---|---|---|---|---|---|
[23] | Model-based formula | Stand-alone | Passive/active | Nurse/Nurse | CDSS + modified protocol | Usability | The system (called eMPC) runs on a bedside laptop computer. |
The model adapts itself to the input–output relationship observed during TGC, i.e., an incoming glucose measurement is used by the model to update insulin resistance taking into account previously administered insulin, parenteral and enteral glucose. | |||||||
At start-up, the algorithm requires the patient’s ID and body weight. The input of the BGL measurement is the first step of a “wizard”, subsequently querying the current status of enteral and parenteral glucose administration. Finally, any advice regarding the insulin infusion rate is given. | |||||||
Profiles of glucose level, insulin rate and the amount of carbohydrates infused by enteral and parenteral administration are displayed on the screen. | |||||||
A countdown timer signals the time until the next glucose measurement. | |||||||
When the enteral/parenteral carbohydrate infusion rate is changed then eMPC suggests a new insulin infusion rate without requiring a new BG measurement. | |||||||
[24] | Model-based formula | Stand-alone | NM | NM | CDSS + modified protocol | No | This software (called EndoTool) upregulates and downregulates a quadratic insulin-dosing relationship based on the entered BG readings from a point-of-care device. It uses engineering-control mathematics that consider the previous four dose responses to regulate the dosing relationship. |
System recommends the insulin dose, glucose determination frequency, and a 50% dextrose dose (when appropriate) for hypoglycemia. | |||||||
How the necessary data should be entered (manually or electronically) was not mentioned. | |||||||
[8] | “If–then” statements | Implemented in PDMS | Active/active | Physicians/physicians | CDSS | No | The system extracted the pump rate and BGLs from PDMS, and suggested the pump rate and the next BGL measurement time. |
It reminded when the next BGL measurement should be done according to the protocol. If the staff took no action, the message would pop up again within a few minutes. | |||||||
When the patient record was activated (bedside computer or any other workstation) the pop up windows would be shown. | |||||||
[9] | Model-based formula | Implemented in CPOE | Passive/passive | Nurses/initiation by physicians and continuation by nurses | CDSS + modified protocol | No | Physician could initiate the CPOE-based insulin protocol, which the patient’s nurse would carry out. Physicians should enter current BGL and target high and low limits. |
At initiation, a highlighted prompt reminds physicians to provide a dextrose source to prevent hypoglycemia. After verifying protocol the CPOE system generates corresponding orders for physician verification, and instructs the nurse to perform subsequent BGL testing. | |||||||
Nurses enter new BGL into the system, and adjust insulin drip rates based on the protocol provided. The nurse can override system pump suggestions and enter it manually based on his/her own decision. It included optional instructions for nurses to notify physicians about out-of-range values. | |||||||
BGLs below target threshold generate an order for intravenous dextrose dose; simultaneously, intravenous insulin infusion is withheld for 1 h. | |||||||
[22] | Model-based formula | Stand-alone | Passive/active | NM/mainly nurses but also physicians | CDSS + modified protocol | Kind of usability and satisfaction were mentioned (not formal) | Installed on stand-alone laptops. The laptops were distributed to clinical areas when patient care with e-Protocol insulin was started. |
Only in one ICU BGLs were automatically retrieved from the hospital electronic medical records. In other three ICUs, nurses manually entered the recent BGL and patient weight. Initial infusion rate was weight-dependent. Thereafter, the current infusion rate, the difference between the most recent entered BGL, the target, and the rate of change of BGL subsequently determined the insulin infusion rate. | |||||||
The e-Protocol-insulin bedside computer displayed the time remaining to the next BGL measurement. | |||||||
Clicking the electronic protocol screen signified an “intent to” accept the recommendation. The nurse still needed to verify drug administration through their usual medical record documentation. When a recommendation was declined, reason was recorded. | |||||||
[10] | Model-based formula | Stand-alone | Passive/active | NM/nurses | CDSS + new protocol | No | Target range can be selected. It is menu-driven, and includes options for starting a new insulin drip, stopping/holding a drip, resuming a prior drip, entering a BG value, specifying the initial insulin sensitivity factor (ISF). |
First BG should be entered manually. Then the system calculates the initial pump rate and the amount of time until next BG measurement. Time and ISF are adjusted whenever a new BG is entered. Based on current and previous BGs, the new rate and next BG measurement time is announced by the program. | |||||||
At the scheduled time for the next measurement, the program sounds an alarm to remind nurse. | |||||||
[25] | Model-based formula | Stand-alone, web-based | Passive/passive | Nurses/nurses | CDSS + new protocol | No | A preprinted order was set on the web site that provided a direct link to an on-line calculator. |
Current, last BGL, and first multiplier should be entered manually. Therefore the computerized system calculates a new multiplier and pump rate. | |||||||
A list of patient non-specific recommendations related to the protocol was given by a computer interface without mentioning which one is more important. | |||||||
[26] | Model-based formula | Stand-alone | Passive/active | Physicians/physicians | CDSS + new protocol | No | The system (called Glucommander) was used in combination with, but independently of, an insulin infusion pump and a glucometer. |
Nurse should enter the first multiplier and the BGLs manually. Except for the first multiplier, other multiplier and the next time for new BGL test was calculated automatically. | |||||||
Time for new BGL test was calculated for use by system reminders. | |||||||
[15] | Model-based formula | Implemented in CPOE | Passive/passive | Nurses/initiation by physicians and continuation by nurses | CDSS + modified protocol | No usage but not formal usability and satisfaction evaluation | Same system as mentioned in Ref. [9]. |
[11] | “If–then” statements | Stand-alone, web-based | Passive/passive | Medical staff, pharmacists, and nurses/nurses | CDSS + new protocol | Usage for three months after end of study was mentioned | A nurse inputs current and last BGL and current pump rate into the bedside computer. Based on entered BGL and last BGL new pump rate was calculated and an interval for the next test was also suggested. |
A list of recommendations related to the protocol was given by the computer interface. | |||||||
[27] | “If–then” statements | Stand-alone, web-based | Passive/passive | Nurses | CDSS + new protocol | Usage was mentioned | A slightly modified version of the protocol and web-based calculator mentioned in Ref. [11] were used in this study. The system was modified to record entered insulin, BGL, and patient’s bed number, and the date and time of calculation. |
[17] | Model-based formula | Stand-alone | Passive/active | NM/nurses | CDSS + new protocol | Only usability and satisfaction were evaluated | Slightly modified version of mentioned protocol and CDSS in Ref. [16] was used in this study. More safety features such as label printing and other features rendering the entire procedure paperless were added. |
[28] | “If–then” statements | Stand-alone | Passive/passive | Physicians/nurses | CDSS + new protocol | No | Current, last BGL, current insulin rate and hourly rate of feeding should be entered manually. Therefore the computerized system calculates needed bolus insulin, pump rate, and next measurement interval. |
A list of patient-non-specific recommendations related to the protocol was given by a computer interface without mentioning which is most important. | |||||||
[29] | “If–then” statements | Stand-alone | Passive/passive | Nurses | CDSS + new protocol | No | A nurse inputs BGL and current pump rate into the system in the bedside computer. Based on entered BGL and last BGL a new pump rate was suggested by the system. |
50% tolerance for delay in BGL test was accepted because the nurses manually entered the BGLs into the system. | |||||||
[7] | Model-based formula | Stand-alone | Passive/active | NM/physicians and nurses | CDSS + new protocol | No | Same system as mentioned in Ref. [26] but now system is connected to the pump and can adjust it directly. |
[16] | Model-based formula | Stand-alone | Passive/active | NM/nurses | CDSS + new protocol | Only usability and satisfaction were evaluated | The system (called GRIP) extracts new BGLs from the hospital information system. Nurses should validate these BGL values and also could change them. Nurses should enter current insulin pump rates, intravenous glucose dose, related drug doses, etc. |
Nurses can see the new rate suggestion and can accept or change it. | |||||||
Time for next BGL test is used in system reminders. | |||||||
[21] | Model-based formula | Stand-alone | Passive/active | NM physicians and nurses | CDSS + new protocol | Not formal satisfaction evaluation |
Indicator | Measurement description | Refs. |
---|---|---|
Blood glucose levels over a time period | Represented as mean and/or median BGL values. Each BGL measurement or each patient was considered as the unit of observation. | |
Measurements in predefined blood glucose ranges | ||
Each BGL measurement was considered as the unit of observation. | ||
Frequency of measurements during the study | ||
Time to capture defined blood glucose target | ||
Time in predefined range | ||
Protocol compliance | A comparison of measurement times suggested by protocol to actual times of measurements and/or pump speed suggested by protocol to actual pump speed during TGC or at the time of hypoglycemia events. | |
Hyperglycemic index | ||
Hyperglycemia events | ||
Number of patients who achieved predefined range | ||
BGL change over time | Represented as BGL change in first 24 h. | One article [16] |
BGL variability | Represented as standard deviation of all measurements per patient. | One article [17] |
Number of patients who did not achieve predefined range | Represented as number and percentage. | One article [25] |
Odds ratio of achieving certain BGL | Per additional IC day and per used drugs. | One article [11] |
Time until first BGL | Represented as mean of time [16]. | |
Time until starting IIT | Proportion of patients per time [15]. | |
Hypoglycemia-related indicator (proxy for safety) | ||
Hypoglycemia events | ||
Severe or marked hypoglycemia events | ||
Mild or moderate hypoglycemia events | <63 was used define a BGL as a mild hypoglycemia event. | |
Next BGL after hypoglycemia | Represented as mean BGL. | |
Time until next in predefined range after hypoglycemia | Represent as mean time. | |
Need for glucose injection | <40 have to inject and <72 should be considered. | One article [27] |
Time until hypoglycemia recognition | Represented as maximum time until hypoglycemia recognition. | One article [7] |
Time until next BGL after hypoglycemia | Represented as mean time. | One article [10] |