NCT03542487

Blood Glucose Monitoring in Electronic Health Records

Completed NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing Practice Orientation in Diabetes Mellitus in 7,052 participants. Completed in 31 October 2018.

Timeline

1 May 2018

Primary endpoint
31 October 2018

31 October 2018

Quick facts

Lead sponsor	Inova Health Care Services
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	prevention
Enrollment	7,052
Start date	1 May 2018
Primary completion	31 October 2018
Estimated completion	31 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Practice Orientation
• Standard Reminder
• Gift Card Reminder
• Physician Reminders

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Inova Health Care Services — full company profile →

Who can join

18 and older, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin Primary · (1-14) weeks after initial practice orientation

Count of participants that entered data to an electronic glucose flowsheet during the measurement period (Count of participants determined with a binary aggregation method; 1= Participant used Flow Sheet at least once during measurement period; 0= Participant did not use Flow Sheet during Measurement Period)

Group	Value	95% CI
1: Control	4
2a: Practice Orientation- No Reminder	27
2b: Practice Orientation- Standard Reminder	44
2c: Practice Orientation- Gift Card Reminder	43
2d: Practice Orientation- Physician Reminder	50

Participant A1c Test Results (as Percent A1c) at 26 Weeks Primary · 26 weeks after initial practice orientation

Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test. The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated. The most recent and available HbA1c test value (percent A1c) in electronic medical records at appropriate time period was used.

Group	Value	95% CI
1: Control	7.179	± 1.540
2a: Practice Orientation- No Reminder	7.327	± 2.894
2b: Practice Orientation- Standard Reminder	7.110	± 1.474
2c: Practice Orientation- Gift Card Reminder	7.227	± 1.623
2d: Practice Orientation- Physician Reminder	7.227	± 1.731

Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin Secondary · Beginning of week 15 to 26 weeks after initial practice orientation

Count of participants that entered data to an electronic glucose flowsheet during the measurement period (Count of participants determined with a binary aggregation method; 1= Participant used Flow Sheet at least once during measurement period; 0= Participant did not use Flow Sheet during Measurement Period)

Group	Value	95% CI
1: Control	4
2a: Practice Orientation- No Reminder	15
2b: Practice Orientation- Standard Reminder	17
2c: Practice Orientation- Gift Card Reminder	20
2d: Practice Orientation- Physician Reminder	30

Number of Days Participant Used Flowsheet, Intensive Secondary · (1-14); (15-26) weeks after initial practice orientation

The total number of days of participant use of the electronic glucose flowsheet during the measurement period. A day of Participant use of electronic glucose flowsheet is defined here as as day (24 hours) in which the participant performed an entry into an electronic glucose flowsheet.

Weeks 1-14

Group	Value	95% CI
1: Control	0.011	± 0.439
2a: Practice Orientation- No Reminder	0.501	± 4.281
2b: Practice Orientation- Standard Reminder	0.350	± 2.693
2c: Practice Orientation- Gift Card Reminder	0.663	± 5.031
2d: Practice Orientation- Physician Reminder	0.691	± 4.683

Weeks 15-26

Group	Value	95% CI
1: Control	0.009	± 0.386
2a: Practice Orientation- No Reminder	0.353	± 3.986
2b: Practice Orientation- Standard Reminder	0.213	± 2.865
2c: Practice Orientation- Gift Card Reminder	0.406	± 4.338
2d: Practice Orientation- Physician Reminder	0.502	± 4.830

Count of Participants With an Open Physician Order for Electronic Glucose Flowsheet Secondary · at 14 and 26 weeks after initial practice orientation

Count of participants that have an open physician order for electronic glucose flowsheet end of the measurement period (Count of participants determined with a binary aggregation method; 1= Participant had an open physician order for electronic Glucose Flow Sheet at end of measurement period; 0= Participant did not have an open physician order for electronic Glucose Flow Sheet at end of measurement period)

Week 14

Group	Value	95% CI
1: Control	5
2a: Practice Orientation- No Reminder	466
2b: Practice Orientation- Standard Reminder	589
2c: Practice Orientation- Gift Card Reminder	554
2d: Practice Orientation- Physician Reminder	573

Week 26

Group	Value	95% CI
1: Control	6
2a: Practice Orientation- No Reminder	466
2b: Practice Orientation- Standard Reminder	589
2c: Practice Orientation- Gift Card Reminder	555
2d: Practice Orientation- Physician Reminder	573

Number of Days Since Last HbA1c Test Secondary · 14; 26 weeks after initial practice orientation

The total number of days that elapsed since participant last had and HbA1c test. The number of days was measured by the number of days that passed from the date of the most recent HbA1c test in the Electronic Medical Record and the date of the data extraction at the specified time point.

Week 14

Group	Value	95% CI
1: Control	196.369	± 201.15
2a: Practice Orientation- No Reminder	196.828	± 205.93
2b: Practice Orientation- Standard Reminder	205.607	± 213.98
2c: Practice Orientation- Gift Card Reminder	192.341	± 192.651
2d: Practice Orientation- Physician Reminder	210.748	± 216.562

Week 26

Group	Value	95% CI
1: Control	196.434	± 207.394
2a: Practice Orientation- No Reminder	208.781	± 215.284
2b: Practice Orientation- Standard Reminder	216.949	± 220.655
2c: Practice Orientation- Gift Card Reminder	202.957	± 206.877
2d: Practice Orientation- Physician Reminder	216.812	± 229.550

Participant A1c Test Results (as Percent A1c) at 14 Weeks Secondary · 14 weeks after initial practice orientation

Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test. The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated. The most recent and available HbA1c test value (percent A1c) in electronic medical records at appropriate time period was used

Group	Value	95% CI
1: Control	7.196	± 1.601
2a: Practice Orientation- No Reminder	7.276	± 2.823
2b: Practice Orientation- Standard Reminder	7.123	± 1.465
2c: Practice Orientation- Gift Card Reminder	7.183	± 1.593
2d: Practice Orientation- Physician Reminder	7.197	± 1.767

Count of Participants With Improvement of HbA1c Test Results Secondary · 14; 26 weeks after initial practice orientation

Count of participants with improved HbA1c test result values in most recent Electronic Medical Record (EMR) during measurement period as compared to HbA1c test value at baseline. (Count of participants determined with a binary aggregation method; 1= Participant Improved, most recent A1c test value less than baseline A1c test value; 0= Participant did not Improve; most recent A1c test value greater than or equal to baseline A1c test value) Improvement of HbA1c test results is defined as a reduction of the most recent and available HbA1c test value (a lower percent A1c) in the EMR at appropriat

At Week 14

Group	Value	95% CI
1: Control	666
2a: Practice Orientation- No Reminder	155
2b: Practice Orientation- Standard Reminder	158
2c: Practice Orientation- Gift Card Reminder	160
2d: Practice Orientation- Physician Reminder	147

At Week 26

Group	Value	95% CI
1: Control	961
2a: Practice Orientation- No Reminder	195
2b: Practice Orientation- Standard Reminder	229
2c: Practice Orientation- Gift Card Reminder	204
2d: Practice Orientation- Physician Reminder	215

Count of Participants With Percent A1c Below Benchmark of 7 Secondary · 14; 26 weeks after initial practice orientation

Count of participants with most recent HbA1c test value (percent A1c) in Electronic Medical Records below target benchmark of 7 at appropriate time point (Count of participants determined with a binary aggregation method; 1= Participant HbA1c test value less than 7; 0= Participant Hb1Ac test value greater than or equal to 7). Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test. The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated. A percent A1c level less than 7 is a common treatment target and is associated with wit

At Week 14

Group	Value	95% CI
1: Control	1846
2a: Practice Orientation- No Reminder	388
2b: Practice Orientation- Standard Reminder	453
2c: Practice Orientation- Gift Card Reminder	442
2d: Practice Orientation- Physician Reminder	458

At Week 26

Group	Value	95% CI
1: Control	1799
2a: Practice Orientation- No Reminder	368
2b: Practice Orientation- Standard Reminder	453
2c: Practice Orientation- Gift Card Reminder	421
2d: Practice Orientation- Physician Reminder	443

Total Secure Messages Sent by Participant Secondary · (1-14); (15-26) weeks after initial practice orientation

Total number of messages sent by participant via MyChart Electronic medical records system during the measurement period

Weeks 1-14

Group	Value	95% CI
1: Control	1.385	± 3.016
2a: Practice Orientation- No Reminder	1.407	± 2.872
2b: Practice Orientation- Standard Reminder	1.528	± 3.272
2c: Practice Orientation- Gift Card Reminder	1.434	± 2.638
2d: Practice Orientation- Physician Reminder	1.571	± 3.282

Weeks 15-26

Group	Value	95% CI
1: Control	1.128	± 2.65
2a: Practice Orientation- No Reminder	1.226	± 2.803
2b: Practice Orientation- Standard Reminder	1.077	± 2.496
2c: Practice Orientation- Gift Card Reminder	1.037	± 2.338
2d: Practice Orientation- Physician Reminder	1.135	± 2.597

Total Number of Participant Phone Appointments Secondary · (1-14); (1-26) weeks after initial practice orientation

Total number of participant phone appointments during the measurement period

Weeks 1-14

Group	Value	95% CI
1: Control	0.792	± 1.651
2a: Practice Orientation- No Reminder	0.827	± 1.64
2b: Practice Orientation- Standard Reminder	0.789	± 1.613
2c: Practice Orientation- Gift Card Reminder	0.849	± 1.654
2d: Practice Orientation- Physician Reminder	0.765	± 1.432

Weeks 1-26

Group	Value	95% CI
1: Control	1.442	± 2.547
2a: Practice Orientation- No Reminder	1.457	± 2.417
2b: Practice Orientation- Standard Reminder	1.398	± 2.506
2c: Practice Orientation- Gift Card Reminder	1.485	± 2.525
2d: Practice Orientation- Physician Reminder	1.434	± 2.420

Total Number of Participant In-person Appointments Secondary · (1-14); (1-26) weeks after initial practice orientation

Total number of participant in-person appointments during the measurement period

Weeks 1-14

Group	Value	95% CI
1: Control	1.275	± 3.476
2a: Practice Orientation- No Reminder	1.314	± 3.914
2b: Practice Orientation- Standard Reminder	1.251	± 3.580
2c: Practice Orientation- Gift Card Reminder	1.109	± 2.782
2d: Practice Orientation- Physician Reminder	1.191	± 2.991

Weeks 1-26

Group	Value	95% CI
1: Control	2.326	± 5.322
2a: Practice Orientation- No Reminder	2.358	± 5.4
2b: Practice Orientation- Standard Reminder	2.153	± 4.775
2c: Practice Orientation- Gift Card Reminder	2.083	± 4.652
2d: Practice Orientation- Physician Reminder	2.188	± 4.452

Sponsor's own description

This multi-site randomized tral aims to test methods of increasing adoption and integration of blood glucose monitoring into electronic medical records, and to measure the impact of wide-scale adoption on health status of patients with diabetes. To investigate determinants of adoption, the research will combine and test doctor and patient focused approaches to encouraging patient use of blood glucose flow sheets through the online patient portal, MyChart. Adoption will be measured on both the extensive and intensive margin: the number of patients who enter data into the flowsheets at all during the study period, and the mean number of entries per patient during the study period. Conditional on statistically significant increases in adoption, the study will examine corresponding intent-to-treat effects on patient A1c, and consider other indicators of possible mechanisms through which A1c improves or does not improve.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.