NCT03178773: TExTMED+FANSII

TExT-MED + FANS Full Trial

Completed Phase 2 Results posted Last updated 6 August 2021

What this trial tests

Phase 2 trial testing TExT-MED in Diabetes in 166 participants. Completed in 2 December 2019.

Timeline

18 July 2017

Primary endpoint
2 December 2019

2 December 2019

Quick facts

Lead sponsor	University of Southern California
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	166
Start date	18 July 2017
Primary completion	2 December 2019
Estimated completion	2 December 2019
Sites	1 location across United States

Drugs / interventions tested

• TExT-MED
• FANS

Conditions studied

• Diabetes — all drugs for Diabetes →

Sponsor

University of Southern California

Who can join

18 and older, any sex, with Diabetes. 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.

Change in HBA1c From Baseline Primary · 6 Months

Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is baseline value minus follow up value.

Group	Value	95% CI
TExT-MED Only	1.42	.83 – 2.02
TExT-MED+FANS	1.34	.53 – 2.15

Change in HBA1c From 6 Months to 12 Months Secondary · 12 months

Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is 6 month value minus 12 month value.

Group	Value	95% CI
TExT-MED Only	-.36	-.93 – .22
TExT-MED+FANS	.28	-.30 – .86

Change in BMI From Baseline Secondary · 6 Months

Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.

Group	Value	95% CI
TExT-MED Only	-7.91	± 33.80
TExT-MED+FANS	-3.84	± 22.94
Total	-5.96	± 29.03

Change in BMI From 6 Months to 12 Months Secondary · 12 Months

Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.

Group	Value	95% CI
TExT-MED Only	-3.38	± 22.51
TExT-MED+FANS	4.02	± 24.88
Total	-0.04	± 23.75

Change in Abdominal Circumference From Baseline Secondary · 6 Months

A measure of central adiposity, it correlates with cardiovascular outcomes.

Group	Value	95% CI
TExT-MED Only	1.58	± 14.70
TExT-MED+FANS	2.73	± 22.54
Total	2.11	± 18.62

Change From Abdominal Circumference From 6 Months to 12 Months Secondary · 12 Months

A measure of central adiposity, it correlates with cardiovascular outcomes.

Group	Value	95% CI
TExT-MED Only	0.99	± 5.10
TExT-MED+FANS	0.85	± 18.51
Total	0.93	± 12.70

Change in Systolic Blood Pressure From Baseline Secondary · 6 Months

Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications

Group	Value	95% CI
TExT-MED Only	-9.11	± 30.45
TExT-MED+FANS	-13.07	± 36.34
Total	-11.00	± 33.28

Change in Systolic Blood Pressure From 6 Months to 12 Months Secondary · 12 Months

Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications

Group	Value	95% CI
TExT-MED Only	-4.95	± 31.81
TExT-MED+FANS	2.09	± 37.46
Total	-1.71	± 34.47

Change in Diastolic Blood Pressure From Baseline Secondary · 6 Months

Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.

Group	Value	95% CI
TExT-MED Only	-0.27	± 17.11
TExT-MED+FANS	-2.56	± 20.09
Total	-1.36	± 18.53

Change in Diastolic Blood Pressure From 6 Months to 12 Months Secondary · 12 Months

Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.

Group	Value	95% CI
TExT-MED Only	-0.82	± 17.39
TExT-MED+FANS	5.20	± 20.15
Total	1.95	± 18.82

Change in Summary of Diabetes Self-care Activities From Baseline Secondary · 6 Months

Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, \& RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert \& Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.

Following a generally healthy diet

Group	Value	95% CI
TExT-MED Only	-1.55	± 2.91
TExT-MED+FANS	-1.17	± 2.69
Total	-1.37	± 2.80

Following a disease specific diet plan

Group	Value	95% CI
TExT-MED Only	-0.42	± 2.12
TExT-MED+FANS	-0.78	± 1.93
Total	-0.59	± 2.03

Self-monitoring blood glucose as advised by a h

Group	Value	95% CI
TExT-MED Only	-0.91	± 3.00
TExT-MED+FANS	-0.10	± 2.84
Total	-0.53	± 2.94

Checking feet daily for wounds

Group	Value	95% CI
TExT-MED Only	-1.25	± 2.96
TExT-MED+FANS	-1.36	± 2.69
Total	-1.30	± 2.83

Spacing carbohydrates throughout the day

Group	Value	95% CI
TExT-MED Only	-0.71	± 4.34
TExT-MED+FANS	-0.20	± 3.31
Total	-0.47	± 3.89

Getting sufficient physical activity

Group	Value	95% CI
TExT-MED Only	-0.39	± 2.99
TExT-MED+FANS	-0.90	± 3.14
Total	-0.63	± 3.06

Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months Secondary · 12 Months

Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, \& RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert \& Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.

Following a generally healthy diet

Group	Value	95% CI
TExT-MED Only	0.23	± 2.50
TExT-MED+FANS	0.96	± 2.74
Total	0.57	± 2.62

Following a disease specific diet plan

Group	Value	95% CI
TExT-MED Only	0.29	± 1.85
TExT-MED+FANS	0.45	± 1.85
Total	0.36	± 1.84

Self-monitoring blood glucose as advised by a h

Group	Value	95% CI
TExT-MED Only	-0.66	± 3.19
TExT-MED+FANS	-0.18	± 2.40
Total	-0.44	± 2.84

Checking feet daily for wounds

Group	Value	95% CI
TExT-MED Only	-0.81	± 2.64
TExT-MED+FANS	0.01	± 1.93
Total	-0.43	± 2.36

Carb Spacing carbohydrates throughout the day

Group	Value	95% CI
TExT-MED Only	0.11	± 4.51
TExT-MED+FANS	0.31	± 3.89
Total	0.20	± 4.22

Getting sufficient physical activity

Group	Value	95% CI
TExT-MED Only	0.11	± 2.97
TExT-MED+FANS	0.81	± 2.88
Total	0.43	± 2.94

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TExT-MED Only

Serious: 21/86 (24%)

Deaths: 0/86

TExT-MED+FANS

Serious: 19/80 (24%)

Deaths: 1/80

Serious adverse events (1 terms)

Reaction	System	TExT-MED Only	TExT-MED+FANS
Report of Hypoglycemic events	Endocrine disorders	—	—

Most-reported serious reactions: Report of Hypoglycemic events.

Data from ClinicalTrials.gov NCT03178773 adverse events section.

Sponsor's own description

This is an intervention to study incorporating social support into mHealth interventions for low-income, ED patients with diabetes

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient navigator programmes for children and adolescents with chronic diseases.
   Lalji R, Koh L, Francis A, Khalid R, et al · · 2024 · cited 7× · PMID 39382077 · DOI 10.1002/14651858.cd014688.pub2
2. mHealth Social Support Versus Standard Support for Diabetes Management in Safety-Net Emergency Department Patients: Randomized Phase-III Trial.
   Burner E, Hazime D, Menchine M, Mack W, et al · · 2025 · cited 2× · PMID 40266665 · DOI 10.2196/56934