An interventional study of Texting in Diabetes, sponsored by Campbell University, Incorporated. Completed at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Campbell University, Incorporated · Not applicable, Interventional, and Supportive care
The purpose of this study is to determine the impact of two-way short message service (SMS) on glycemic control in low-income, poorly-controlled adult diabetic patients.
This multi-center, unblinded, prospective randomized controlled trial will enroll adult diabetic patients of the Wilson Community Health Center, Harvest Family Health Center, and Freedom Hill Community Health Center living below 200% of 2013 poverty level with a serum hemoglobin A1C >9% and who currently own a mobile device with text messaging capacity. After written informed consent has been obtained, subjects will be randomized to intervention or control group (1:1), stratified based on insulin initiation within 1 week of study inclusion. Participants randomized to the intervention group will be further divided into subgroups as "insulin user" or "non-insulin user" and both will receive SMS messages every 7 days. The content of the message consist of medication reminders, reporting of blood glucose results, insulin technique assessment (if applicable), or d) medication adherence assessment. Participants will be asked to respond with a simple text within 7 days. The intervention group will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the Health Center PLUS a unidirectional text message two business days prior to scheduled health center appointments. Control group participants will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the health center. All participants in the study (control and intervention) will undergo venipuncture at 3 months (+/-) 2 weeks for the determination of hemoglobin A1C. Demographic information, and frequency of hemoglobin A1C concentrations in the past 6 months will be assessed at baseline. Each week for 12 weeks, the number of texts sent per week and by type, percent of respondents weekly by text or by phone, content of participant responses, number of patients unable to be reached via text, total investigator time spent per week, and time spent per contact will be recorded. At the three month visit, the hemoglobin A1C concentration, blood transfusions since study initiation, and medication changes will be recorded.
Exclusion Criteria:
Care as usual; no bidirectional texting
Bidirectional texting weekly for 12 weeks
Other: Texting
Bidirectional texting once weekly for 12 weeks
Change From Baseline A1C
Change in A1C from baseline
Time frame: 12 weeks
Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes
Change in A1C from baseline based on age, gender, race, type and duration of diabetes
Time frame: 12 weeks
| Milestone | Control Group | Texting |
|---|---|---|
| Started | 95 | 75 |
| Completed | 69 | 56 |
| Not completed | 26 | 19 |
| Withdrew: Lost to follow-up | 26 | 19 |
Change in A1C from baseline
| percentage of A1C decrease | Control Group | Texting |
|---|---|---|
| Change From Baseline A1C | 1.1 (0.6 to 1.6) | 1.4 (0.9 to 1.8) |
Change in A1C from baseline based on age, gender, race, type and duration of diabetes
| percentage of A1C decrease | Control Group | Texting |
|---|---|---|
| Age 18-35 | 2.1 (0.3 to 4.0) | 1.9 (0.5 to 2.0) |
| 36-55 years | 1.2 (0.5 to 1.8) | 1.4 (0.8 to 2.1) |
| 56-65 years | 0.5 (0.2 to 1.2) | 1.5 (0.5 to 2.6) |
| >65 years | 0.8 (0.33 to 1.9) | 1.2 (0.2 to 2.2) |
| African American | 1.2 (0.5 to 1.7) | 1.3 (0.7 to 1.8) |
| Caucasian | 1.0 (0.2 to 1.7) | 1.4 (0.8 to 2.0) |
| Hispanic | 2.0 (NA to NA) | 0.9 (NA to NA) |
| Other | 1.0 (NA to NA) | 3.0 (NA to NA) |
| Female | 0.9 (0.3 to 1.4) | 1.3 (0.8 to 1.7) |
| Male | 1.4 (0.6 to 2.4) | 1.5 (0.7 to 2.4) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | — | 0/95 (0%) | 0/95 (0%) |
| Texting | — | 0/75 (0%) | 0/75 (0%) |
| Age, Categorical(Participants) | Control Group | Texting | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 65 | 51 | 116 |
| >=65 years | 4 | 5 | 9 |
| Age, Continuous(years) | Control Group | Texting | Total |
|---|---|---|---|
| Mean | 50.4 ± 9.7 | 52.5 ± 10.3 | 51.3 ± 10.0 |
| Sex: Female, Male(Participants) | Control Group | Texting | Total |
|---|---|---|---|
| Female | 41 | 32 | 73 |
| Male | 28 | 24 | 52 |
| Race/Ethnicity, Customized(Participants) | Control Group | Texting | Total |
|---|---|---|---|
| African American | 50 | 42 | 92 |
| Caucasian | 15 | 10 | 25 |
| Hispanic | 2 | 1 | 3 |
| Other | 2 | 3 | 5 |
| Region of Enrollment(Participants) | Control Group | Texting | Total |
|---|---|---|---|
| United States | 69 | 56 | 125 |
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Campbell University, Incorporated