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mHealth Intervention to Support Diabetes Medication Adherence (Pilot Study)
NA trial testing DIABE-TEXT in Diabetes Mellitus, Type 2 in 207 participants. Completed in 28 June 2021.
| Lead sponsor | Fundació d'investigació Sanitària de les Illes Balears |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 207 |
| Start date | 30 December 2020 |
| Primary completion | 18 April 2021 |
| Estimated completion | 28 June 2021 |
| Sites | 1 location across Spain |
Fundació d'investigació Sanitària de les Illes Balears
18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
HbA1c was extracted as percentage which is calculated following the standard formulae \[HbA1c(%)=(HbA1c(mmol/mol)+23.5)/10.93\] based on its concentration in blood samples. It identifies average plasma glucose concentration.
| Group | Value | 95% CI |
|---|---|---|
| DIABE-TEXT | 9 | ± 1 |
| Usual Care | 9.1 | ± 1.3 |
| Group | Value | 95% CI |
|---|---|---|
| DIABE-TEXT | 7.7 | ± 1.3 |
| Usual Care | 7.6 | ± 1.2 |
Number of participants classified as adherent based on Self-reported adherence to glucose medications was measured with a 7-items ad hoc questionnaire adapted from Chaves-Torres et al. for people with type 2 diabetes. Participants who obtained 7 points were considered adherent while the ones with \< 7 points were non-adherent.
| Group | Value | 95% CI |
|---|---|---|
| DIABE-TEXT | 72 | |
| Usual Care | 76 |
| Group | Value | 95% CI |
|---|---|---|
| DIABE-TEXT | 73 | |
| Usual Care | 62 |
(Patients enroled/ Total Eligible patients) x 100 percent
| Group | Value | 95% CI |
|---|---|---|
| Eligible Participants | 207 |
(Patients who finish follow-up/Total recruited) x 100 percent
| Group | Value | 95% CI |
|---|---|---|
| DIABE-TEXT | 89 | |
| Usual Care | 90 |
The 14-point Mediterranean Diet Adherence Screener (MEDAS-14) questionnaire was registered at baseline and post-intervention. Participants were classified as low adherents (≤5), moderate adherents (6 to 9 points) or high adherents (≥10 points) according to the results obtained that can range between 1 to 14 points. After that, we joined moderate adherents with high adherents and tagged them as adherents to the Mediterranean Diet, while low adherents were considered non-adherents to the Mediterranean diet. Therefore, we presented the number of participants adherent to the MediterraneanDiet. A h
| Group | Value | 95% CI |
|---|---|---|
| DIABE-TEXT | 49 | |
| Usual Care | 55 |
| Group | Value | 95% CI |
|---|---|---|
| DIABE-TEXT | 53 | |
| Usual Care | 43 |
A 6-items adapted from the short version of the International Physical Activity Questionnaire (IPAQ) (11) was registered at baseline and post-intervention. Participants were classified as having a low, moderate or high level of physical activity based on metabolic equivalent of task (METs) calculation. After that, we joined the participants that presented moderate or high level of physical activity and tagged them as adherents to Physical Activity recommendations, while having low levels of Physical Activity was considered as being non-adherent to the Physical Activity Recommendations. Therefo
| Group | Value | 95% CI |
|---|---|---|
| DIABE-TEXT | 56 | |
| Usual Care | 55 |
| Group | Value | 95% CI |
|---|---|---|
| DIABE-TEXT | 62 | |
| Usual Care | 52 |
Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | DIABE-TEXT | Usual Care |
|---|---|---|---|
| Feeling emotionally distressed | Investigations | — | — |
Data from ClinicalTrials.gov NCT04738591 adverse events section.
This study aims at evaluating the feasibility of an intervention based on the use of a mobile-device based system delivering automated, tailored brief text messages to offer support for medicine use and lifestyle recommendations alongside usual care to people with type 2 diabetes.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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