Trial Outcomes & Findings for Three Approaches to Glucose Monitoring in Non-insulin Treated Diabetes (NCT NCT02033499)

NCT ID: NCT02033499

Last Updated: 2017-12-14

Results Overview

Absolute Change in Glycemic Control (% Hemoglobin A1c) from baseline at 52 weeks

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 450 participants
• Primary outcome timeframe: Baseline to 52 weeks
• Results posted on: 2017-12-14

Participant Flow

Potential participants were identified via the electronic health record (EHR) and were called to determine if they met inclusion criteria that not available from the EHR: did not plan to move or get pregnant in the next year, did not see an endocrinologist for their diabetes care, and was a patient of record in one of the 15 participating clinics.

Participant milestones

Measure	No Testing No SMBG testing	SMBG Standard Messaging Daily SMBG with standard messaging	SMBG Enhanced Messaging Daily SMBG with enhanced messaging
Overall Study STARTED	152	150	148
Overall Study COMPLETED	147	142	139
Overall Study NOT COMPLETED	5	8	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Three Approaches to Glucose Monitoring in Non-insulin Treated Diabetes

Baseline characteristics by cohort

Measure	No Testing n=152 Participants No SMBG testing	SMBG Standard Messaging n=150 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=148 Participants Daily SMBG with enhanced messaging	Total n=450 Participants Total of all reporting groups
Age, Continuous	60.9 Years STANDARD_DEVIATION 11.6 • n=5 Participants	59.9 Years STANDARD_DEVIATION 11.4 • n=7 Participants	60.7 Years STANDARD_DEVIATION 11.5 • n=5 Participants	60.5 Years STANDARD_DEVIATION 11.5 • n=4 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	83 Participants n=7 Participants	66 Participants n=5 Participants	227 Participants n=4 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	67 Participants n=7 Participants	82 Participants n=5 Participants	223 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	148 Participants n=5 Participants	147 Participants n=7 Participants	146 Participants n=5 Participants	441 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	42 Participants n=5 Participants	55 Participants n=7 Participants	51 Participants n=5 Participants	148 Participants n=4 Participants
Race (NIH/OMB) White	104 Participants n=5 Participants	89 Participants n=7 Participants	86 Participants n=5 Participants	279 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	152 participants n=5 Participants	150 participants n=7 Participants	148 participants n=5 Participants	450 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 52 weeks

Population: Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to provide blood samples yet were able to complete all or part of the patient interview.

Absolute Change in Glycemic Control (% Hemoglobin A1c) from baseline at 52 weeks

Outcome measures

Measure	No Testing n=147 Participants No Self-Monitoring of Blood Glucose (SMBG) testing	SMBG Standard Messaging n=141 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=139 Participants Daily SMBG with enhanced messaging
Absolute Change in % Hemoglobin A1c From Baseline at 52 Weeks	0.04 Percent Hemoglobin A1c Standard Deviation 1.12	-0.05 Percent Hemoglobin A1c Standard Deviation 1.00	-0.10 Percent Hemoglobin A1c Standard Deviation 1.14

PRIMARY outcome

Timeframe: Baseline to 52 weeks

Population: Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete the SF-36, yet did provide blood samples for A1c testing.

Change in Short Form-36 (SF-36) subscale scores (Physical and Mental subscales) from baseline to 52 weeks. The SF-36 is a widely used measure of health-related quality of life. Each subscale score ranges from 0 - 100, with 100 being the best quality of life score.

Outcome measures

Measure	No Testing n=143 Participants No Self-Monitoring of Blood Glucose (SMBG) testing	SMBG Standard Messaging n=142 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=135 Participants Daily SMBG with enhanced messaging
Mean Difference in Health-related Quality of Life Scores From Baseline to 52 Weeks SF-36: Physical Score	-.43 Units on a scale Standard Deviation 6.86	.07 Units on a scale Standard Deviation 6.77	-.35 Units on a scale Standard Deviation 6.95
Mean Difference in Health-related Quality of Life Scores From Baseline to 52 Weeks SF-36: Mental Score	-.94 Units on a scale Standard Deviation 7.46	-.71 Units on a scale Standard Deviation 7.72	-1.39 Units on a scale Standard Deviation 6.85

SECONDARY outcome

Timeframe: Baseline to 52 weeks

Population: Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.

The change from baseline Problem Areas in Diabetes (PAID) scores will be assessed at 52 weeks. The PAID is a widely used tool to assess psychological and social stress associated with diabetes. The PAID scores range from 0 to 100, with 100 indicating the most distress.

Outcome measures

Measure	No Testing n=143 Participants No Self-Monitoring of Blood Glucose (SMBG) testing	SMBG Standard Messaging n=142 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=135 Participants Daily SMBG with enhanced messaging
Change in Problem Areas in Diabetes Scores From Baseline to 52 Weeks	-1.97 units on a scale Standard Deviation 15.44	-4.01 units on a scale Standard Deviation 12.16	-3.84 units on a scale Standard Deviation 13.53

SECONDARY outcome

Timeframe: Baseline to 52 weeks

Population: Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.

Change in diabetes-related symptom frequency and perceived severity from baseline at 52 weeks using the Diabetes Symptom Checklist-Revised. Overall score ranges from 0 to 170, with 170 indicating the worse symptom severity.

Outcome measures

Measure	No Testing n=143 Participants No Self-Monitoring of Blood Glucose (SMBG) testing	SMBG Standard Messaging n=142 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=135 Participants Daily SMBG with enhanced messaging
Change in Diabetes Symptom Checklist- Revised (DSC-R) Overall Score From Baseline to 52 Weeks	2.15 units on a scale Standard Deviation 14.37	-2.36 units on a scale Standard Deviation 15.37	.53 units on a scale Standard Deviation 14.78

SECONDARY outcome

Timeframe: Baseline to 52 weeks

Population: Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.

Change in the SDCA subscales (general diet, specific diet, exercise, blood sugar testing, and foot care), a multidimensional measure of diabetes self-management activities, from baseline at 52 weeks will be assessed. For each subscale, the score is the mean number of days specified subscale activities occurred. Each subscale ranges from 0 to 7, with 7 the best score possible.

Outcome measures

Measure	No Testing n=143 Participants No Self-Monitoring of Blood Glucose (SMBG) testing	SMBG Standard Messaging n=142 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=135 Participants Daily SMBG with enhanced messaging
Change in Summary of Diabetes Self Care Activities (SDCA) Subscales From Baseline to 52 Weeks General diet	.24 units on a scale Standard Deviation 2.22	.45 units on a scale Standard Deviation 2.26	.17 units on a scale Standard Deviation 2.11
Change in Summary of Diabetes Self Care Activities (SDCA) Subscales From Baseline to 52 Weeks Specific diet	.11 units on a scale Standard Deviation 1.80	-.03 units on a scale Standard Deviation 1.64	.09 units on a scale Standard Deviation 1.70
Change in Summary of Diabetes Self Care Activities (SDCA) Subscales From Baseline to 52 Weeks Exercise	.30 units on a scale Standard Deviation 2.07	.22 units on a scale Standard Deviation 2.10	.37 units on a scale Standard Deviation 2.48
Change in Summary of Diabetes Self Care Activities (SDCA) Subscales From Baseline to 52 Weeks Blood sugar testing	-1.46 units on a scale Standard Deviation 2.83	2.94 units on a scale Standard Deviation 3.23	2.81 units on a scale Standard Deviation 3.30
Change in Summary of Diabetes Self Care Activities (SDCA) Subscales From Baseline to 52 Weeks Foot care	.10 units on a scale Standard Deviation 2.32	.27 units on a scale Standard Deviation 2.44	.39 units on a scale Standard Deviation 2.22

SECONDARY outcome

Timeframe: Baseline to 52 weeks

Population: Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing.

Change from baseline patient satisfaction with treatment at 52 weeks using the Diabetes Treatment Satisfaction Questionnaire subscales, overall satisfaction and satisfaction with blood glucose control. For overall satisfaction, the range is 0-36, with 36 (high score) being the most satisfied. For satisfaction with blood glucose control, the subscale range is 0 to 12, with 0 (low score) indicating the most satisfaction.

Outcome measures

Measure	No Testing n=133 Participants No Self-Monitoring of Blood Glucose (SMBG) testing	SMBG Standard Messaging n=138 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=135 Participants Daily SMBG with enhanced messaging
Change in Diabetes Treatment Satisfaction Questionnaire Subscale Scores From Baseline to 52 Weeks Overall satisfaction	-.16 units on a scale Standard Deviation 6.26	.67 units on a scale Standard Deviation 4.95	-.28 units on a scale Standard Deviation 5.84
Change in Diabetes Treatment Satisfaction Questionnaire Subscale Scores From Baseline to 52 Weeks Perceived blood glucose control	.01 units on a scale Standard Deviation 2.96	-.12 units on a scale Standard Deviation 3.08	-.31 units on a scale Standard Deviation 2.93

SECONDARY outcome

Timeframe: Baseline to 52 weeks

Population: Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing.

Changes in diabetes-specific self-efficacy using the Diabetes Empowerment Scale - Short Form from baseline at 52 weeks. The scale ranges from 1 to 5, with 5 indicating most empowered.

Outcome measures

Measure	No Testing n=143 Participants No Self-Monitoring of Blood Glucose (SMBG) testing	SMBG Standard Messaging n=141 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=135 Participants Daily SMBG with enhanced messaging
Change Diabetes Empowerment Scale - Short Form (DES-SF) From Baseline to 52 Weeks	.08 units on a scale Standard Deviation .53	.11 units on a scale Standard Deviation .50	.20 units on a scale Standard Deviation .49

SECONDARY outcome

Timeframe: Baseline to 52 weeks

Population: Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.

Change from baseline patient perception of communication with their provider at 52 weeks using the Communication Assessment Tool (CAT). Scale scores range from 1 to 5, with 5 being the best communication.

Outcome measures

Measure	No Testing n=141 Participants No Self-Monitoring of Blood Glucose (SMBG) testing	SMBG Standard Messaging n=142 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=134 Participants Daily SMBG with enhanced messaging
Change in Patient-Provider Communication From Baseline to 52 Weeks	.03 units on a scale Standard Deviation .68	-.02 units on a scale Standard Deviation .65	.01 units on a scale Standard Deviation .75

SECONDARY outcome

Timeframe: Baseline to 52 weeks

Population: Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to provide information for this measure, yet did provide blood samples for A1c testing and vice versa.

Number of participants with hypoglycemia events for the 52 week intervention period.

Outcome measures

Measure	No Testing n=144 Participants No Self-Monitoring of Blood Glucose (SMBG) testing	SMBG Standard Messaging n=142 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=135 Participants Daily SMBG with enhanced messaging
Hypoglycemia Frequency	3 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able provide this information, yet did provide blood samples for A1c testing and vice versa.

Primary care visits, hospitalization, urgent care, and emergency room and emergency medical service (EMS) visits recorded at baseline and 52 weeks.

Outcome measures

Measure	No Testing n=144 Participants No Self-Monitoring of Blood Glucose (SMBG) testing	SMBG Standard Messaging n=142 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=135 Participants Daily SMBG with enhanced messaging
Baseline Health Care Utilization and at 52 Weeks Primary care provider visits (baseline)	4.0 number of events Standard Deviation 3.0	3.4 number of events Standard Deviation 1.6	3.7 number of events Standard Deviation 2.3
Baseline Health Care Utilization and at 52 Weeks Primary care provider visits (follow-up))	3.5 number of events Standard Deviation 2.4	3.5 number of events Standard Deviation 2.8	3.5 number of events Standard Deviation 1.8
Baseline Health Care Utilization and at 52 Weeks Urgent Care visits - baseline	.5 number of events Standard Deviation 1.3	.4 number of events Standard Deviation 1.0	.4 number of events Standard Deviation .8
Baseline Health Care Utilization and at 52 Weeks Urgent Care visits - follow-up	.3 number of events Standard Deviation .7	.3 number of events Standard Deviation .8	.3 number of events Standard Deviation .6
Baseline Health Care Utilization and at 52 Weeks Emergency room visits - baseline	.5 number of events Standard Deviation 1.3	.2 number of events Standard Deviation .5	.5 number of events Standard Deviation 1.3
Baseline Health Care Utilization and at 52 Weeks Emergency room visits - follow-up	.3 number of events Standard Deviation .7	.3 number of events Standard Deviation .6	.4 number of events Standard Deviation 1.0
Baseline Health Care Utilization and at 52 Weeks Overnight hospitalization - baseline	.1 number of events Standard Deviation .3	.1 number of events Standard Deviation .4	.1 number of events Standard Deviation .3
Baseline Health Care Utilization and at 52 Weeks Overnight hospitalization - follow-up	.1 number of events Standard Deviation .3	.1 number of events Standard Deviation .4	.1 number of events Standard Deviation .4
Baseline Health Care Utilization and at 52 Weeks EMS called - baseline	.2 number of events Standard Deviation .6	.1 number of events Standard Deviation .2	.1 number of events Standard Deviation .2
Baseline Health Care Utilization and at 52 Weeks EMS called - follow-up	.1 number of events Standard Deviation .3	0.0 number of events Standard Deviation .2	.1 number of events Standard Deviation .3

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Medication regimens vary among patients.

Number of participants taking each of the following medications at baseline and follow-up: metformin, sulfonylurea, glinides, Glucagon-like peptide-1 (GLP-1), Thiazolidinediones (TZD), and dipeptidyl peptidase IV (DPP-IV).

Outcome measures

Measure	No Testing n=152 Participants No Self-Monitoring of Blood Glucose (SMBG) testing	SMBG Standard Messaging n=150 Participants Daily SMBG with standard messaging	SMBG Enhanced Messaging n=148 Participants Daily SMBG with enhanced messaging
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up Metformin - baseline	123 Participants	115 Participants	120 Participants
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up Metformin - follow-up	124 Participants	114 Participants	111 Participants
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up Sulfonylurea - baseline	50 Participants	49 Participants	60 Participants
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up Sulfonylurea - follow-up	56 Participants	63 Participants	65 Participants
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up Glinides - baseline	1 Participants	1 Participants	0 Participants
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up Glinides - follow-up	0 Participants	1 Participants	0 Participants
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up GLP-1 - baseline	5 Participants	2 Participants	10 Participants
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up GLP-1 - follow-up	6 Participants	6 Participants	11 Participants
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up TZD - baseline	8 Participants	3 Participants	10 Participants
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up TZD - follow-up	7 Participants	1 Participants	14 Participants
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up DPP-IV - baseline	12 Participants	11 Participants	17 Participants
Number of Participants on Specified Diabetes Medications at Baseline and Follow-up DPP-IV - follow-up	16 Participants	14 Participants	17 Participants

Adverse Events

No Testing

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

SMBG Standard Messaging

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

SMBG Enhanced Messaging

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	No Testing n=152 participants at risk No SMBG testing	SMBG Standard Messaging n=150 participants at risk Daily SMBG with standard messaging	SMBG Enhanced Messaging n=148 participants at risk Daily SMBG with enhanced messaging
Nervous system disorders Death	0.66% 1/152 • Number of events 1 • From Randomization date until Final Visit date: 52 weeks +-6 weeks	0.00% 0/150 • From Randomization date until Final Visit date: 52 weeks +-6 weeks	0.00% 0/148 • From Randomization date until Final Visit date: 52 weeks +-6 weeks
Cardiac disorders Death	0.66% 1/152 • Number of events 1 • From Randomization date until Final Visit date: 52 weeks +-6 weeks	0.00% 0/150 • From Randomization date until Final Visit date: 52 weeks +-6 weeks	0.00% 0/148 • From Randomization date until Final Visit date: 52 weeks +-6 weeks
Renal and urinary disorders Severe Hypoglycemia	0.00% 0/152 • From Randomization date until Final Visit date: 52 weeks +-6 weeks	0.00% 0/150 • From Randomization date until Final Visit date: 52 weeks +-6 weeks	0.68% 1/148 • Number of events 1 • From Randomization date until Final Visit date: 52 weeks +-6 weeks

Other adverse events

Measure	No Testing n=152 participants at risk No SMBG testing	SMBG Standard Messaging n=150 participants at risk Daily SMBG with standard messaging	SMBG Enhanced Messaging n=148 participants at risk Daily SMBG with enhanced messaging
General disorders Hospitalization	3.9% 6/152 • Number of events 6 • From Randomization date until Final Visit date: 52 weeks +-6 weeks	6.0% 9/150 • Number of events 9 • From Randomization date until Final Visit date: 52 weeks +-6 weeks	6.8% 10/148 • Number of events 10 • From Randomization date until Final Visit date: 52 weeks +-6 weeks

Additional Information

Dr. Katrina Donahue

University of North Carolina at Chapel Hill

Phone: 919-966-5090

Email: Katrina_Donahue@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place