Diabetes Mellitus, Type 2DIABE-TEXTNCT05006872

mHealth Intervention to Support Diabetes Medication Adherence

A study testing DIABE-TEXT in people with Diabetes Mellitus, Type 2, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study aims at evaluating the effectiveness 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: DIABE-TEXT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 742 participants
Where: 1 siteSpain
Study dates: 6 Oct 2021to 30 Apr 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients registered in the Public Health Service of the Balearic Islands
With type 2 diabetes
At least one prescription of a glucose-lowering drug
With results of HbA1c>8% from 6 months prior to recruitment

Who cannot join

Younger than 18 years old
With insulin treatment
Participating in another research study
Not living in the Balearic Islands at some point during the study development

Trial locations and contacts

1 site in 1 country.

Spain1 site

Ignacio Ricci-Cabello
Palma de Mallorca, Balearic Islands, 07002

Other trials in Spain

About this study

Official title: Supporting People With Type 2 Diabetes in Effective Use of Their Medicine Through a System Comprising Mobile Health Technology Integrated With Clinical Care

Read the detailed description

A list of patients registered in primary care centers of the Balearic Islands and potentially meeting the eligibility criteria will be obtained from electronic health records (EHRs). A research assistant will contact the potential participants via phone to invite them to the study and confirm eligibility. All eligible participants will complete informed consent followed by baseline assessment over the phone before randomization. Participants will be randomly allocated using a computer-generated randomization sequence. All participants will continue with their usual diabetes care including all medical visits, tests, and diabetes support programs throughout the study. In addition, the intervention group will receive the text messaging intervention. Control participants will receive usual care only.

After twelve months of follow-up, all participants will complete post-intervention assessments via phone interview. Data on glycemic control (HbA1c) at baseline and post-intervention will be extracted from EHRs, as according to the protocol used for primary care providers in the Balearic Islands, patients with poor glycemic control (HbA1c >8% ) must request an HbA1c determination every six months. Results of the most recent determination will be extracted from electronic medical records. For those patients with no recorded HbA1c within the previous four months, the research assistant will contact the primary care center to arrange blood test analyses.

Conditions: Diabetes Mellitus, Type 2
Being tested: DIABE-TEXT
Keywords: diabetes, medication, adherence, glycaemic control, healthy lifestyle, mHealth, SMS
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DIABE-TEXTDevice
Participants will receive 170 text messages in their mobile phones during twelve months.

Study groups in NCT05006872
Study group	Role	What they receive
DIABE-TEXT	Experimental	Participants allocated to the intervention group will receive text messages in their mobile phones with content about diabetes management, general information about diabetes, medicines, diet and physical activity recommendations and motivational prompts to engage participants in a healthy lifestyle and a good adherence to medication plan. They will also receive reminders for healthcare visits, drug dispensation from the pharmacy and updated results from blood test records. Receives: Device: DIABE-TEXT
Usual care	No intervention	Participants allocated to the control group will not receive any intervention apart from usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

Glycated Hemoglobin (HbA1c) (%)
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 (1).
The most recent HbA1c data registered between 6th of April and 12th of November in 2021 were extracted for all participants at baseline.
At post-intervention, we extracted the most recent data which was available between 21st September 2022 and 21st February 2023.
Measured: Baseline and post-intervention at 12 months
Mean Adherence to Antidiabetic Drugs (%)
We calculated adherence in terms of medication possession ratio (MPR), defined as the number of days with treatment as medication being dispensed from the pharmacy to the patient (numerator), out of the total days of treatment prescribed by the doctor (denominator) (2):
MPR = [Days with treatment (prescription dispensed) / Days with treatment as prescribed by the doctor] x 100
At baseline it was calculated as the mean adherence for all the glucose lowering drugs prescribed during the 6 months previous to recruitment excluding insulin.
At post-intervention it was calculated as the mean adherence for all the glucose lowering drugs prescribed during the 12 months follow-up excluding insulin.
Measured: Baseline and post-intervention at 12 months

Secondary outcomes (3)

Number of Participants Classified as Adherent Based on Self-reported Adherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire)
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.
Measured: Baseline and post-intervention at 12 months
Health-related Quality of Life (EQ-5D-5L)
The 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L) questionnaire was completed at baseline and post-intervention interviews. The index score was calculated using STATA syntax code and values with the Spanish value set according to Ramos-Goñi JM et al. Information about the EQ-5D index, derived using a value set, can be presented in much the same way as the EQ VAS data, i.e. using measures of central tendency and dispersion, such as mean values and the SD (or standard error). If the data are skewed, the median values and the 25th and 75th percentiles could be presented. Note, when reporting index values, a maximum of three decimal places is usually sufficient. Index values can range between 0 to 1. Higher EQ-5D index scores mean better quality of life related to health status.
Measured: Baseline and post-intervention at 12 months
Self-efficacy to Manage Diabetes (DSES-S)
The validated scale known as diabetes management self-efficacy scale in Spanish (DSES-S) was completed at baseline and post-intervention interviews. The scales consist of 8 Likert-type 10-point items. The score for each item was the number circled. If two consecutive numbers were circled, the lower number (less self-efficacy) was coded. If the numbers were not consecutive, the item was not scored. The final score for the scale is the mean of the eight items (points). Therefore, DSES-S scores range between 1 to 10. If more than two items were missing, we did not score the scale following instructions. Higher number indicates higher self-efficacy.
Measured: Baseline and post-intervention at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 202130 Apr 2023

First posted16 Aug 2021
Study start6 Oct 2021
Primary completion31 Mar 2023
Study completion30 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 742 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05006872
Sponsor's protocol ID: RTI2018-096935-A-100_rct
Other IDs: IB 4320/20 PI
Acronym: DIABE-TEXT
Status last verified: Feb 2022
First submitted: 9 Aug 2021
Last updated: 28 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Zamanillo-Campos R, Fiol-DeRoque MA, Serrano-Ripoll MJ, Mira-Martinez S, Llobera-Canaves J, Taltavull-Aparicio JM, Leiva-Rus A, Ripoll-Amengual J, Angullo-Martinez E, Socias-Buades IM, Masmiquel-Comas L, Konieczna J, Zaforteza-Dezcallar M, Boronat-Moreiro MA, Gervilla-Garcia E, Ricci-Cabello I. DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2024 Jan;136:107399. doi: 10.1016/j.cct.2023.107399. Epub 2023 Nov 22.
PubMed 37995967

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Supporting People With Type 2 Diabetes in Effective Use of Their Medicine Through a System Comprising Mobile Health Technology Integrated With Clinical Care
ClinicalTrials.gov ID: NCT05006872
Acronym / sponsor ID: DIABE-TEXT / RTI2018-096935-A-100_rct
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes, medication, adherence, glycaemic control, healthy lifestyle, mHealth, SMS
Study type: Interventional
Recruitment status: Completed
Enrolment: 742 participants (actual)
Lead sponsor: Fundació d'investigació Sanitària de les Illes BalearsOther government
Study start: 6 Oct 2021 (actual)
Primary completion: 31 Mar 2023 (actual)
Study completion: 30 Apr 2023 (actual)
First posted: 16 Aug 2021 (actual)
Results: Posted 28 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DIABE-TEXT	Experimental	Device: DIABE-TEXTParticipants allocated to the intervention group will receive text messages in their mobile phones with content about diabetes management, general information about diabetes, medicines, diet and physical activity recommendations and motivational prompts to engage participants in a healthy lifestyle and a good adherence to medication plan. They will also receive reminders for healthcare visits, drug dispensation from the pharmacy and updated results from blood test records.
Usual care	No intervention	–Participants allocated to the control group will not receive any intervention apart from usual care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients registered in the Public Health Service of the Balearic Islands
With type 2 diabetes
At least one prescription of a glucose-lowering drug
With results of HbA1c>8% from 6 months prior to recruitment

Key exclusion criteria (4 listed)

Younger than 18 years old
With insulin treatment
Participating in another research study
Not living in the Balearic Islands at some point during the study development

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DIABE-TEXTParticipants will receive 170 text messages in their mobile phones during twelve months.	Device	DIABE-TEXT

Primary outcome

Glycated Hemoglobin (HbA1c) (%)
Time frame: Baseline and post-intervention at 12 months
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 (1). The most recent HbA1c data registered between 6th of April and 12th of November in 2021 were extracted for all participants at baseline. At post-intervention, we extracted the most recent data which was available between 21st September 2022 and 21st February 2023.
Mean Adherence to Antidiabetic Drugs (%)
Time frame: Baseline and post-intervention at 12 months
We calculated adherence in terms of medication possession ratio (MPR), defined as the number of days with treatment as medication being dispensed from the pharmacy to the patient (numerator), out of the total days of treatment prescribed by the doctor (denominator) (2): MPR = [Days with treatment (prescription dispensed) / Days with treatment as prescribed by the doctor] x 100 At baseline it was calculated as the mean adherence for all the glucose lowering drugs prescribed during the 6 months previous to recruitment excluding insulin. At post-intervention it was calculated as the mean adherence for all the glucose lowering drugs prescribed during the 12 months follow-up excluding insulin.

3 secondary outcomes

Number of Participants Classified as Adherent Based on Self-reported Adherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire)
Time frame: Baseline and post-intervention at 12 months
Health-related Quality of Life (EQ-5D-5L)
Time frame: Baseline and post-intervention at 12 months
Self-efficacy to Manage Diabetes (DSES-S)
Time frame: Baseline and post-intervention at 12 months

Results and safety

Results posted to the registry on 28 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DIABE-TEXT	371	334
Usual Care	371	340

Primary outcome: Glycated Hemoglobin (HbA1c) (%)

Time frame: Baseline and post-intervention at 12 months. Median (Inter-Quartile Range). Unit: Percentage of HbA1c

Measure	DIABE-TEXT n = 371	Usual Care n = 371
Baseline	8.1 (7.7 to 8.7)	8.0 (7.6 to 8.8)
Post-intervention	7.5 (6.7 to 8.2)	7.4 (6.7 to 8.3)

Population analysed: The number analyzed post-intervention differs from overall number analyzed because of losses to follow-up.

Primary outcome: Mean Adherence to Antidiabetic Drugs (%)

Time frame: Baseline and post-intervention at 12 months. Median (Inter-Quartile Range). Unit: Medication possession ratio (percentage)

Measure	DIABE-TEXT n = 371	Usual Care n = 371
Baseline	95.1 (81.8 to 99.3)	96.2 (83.1 to 99.3)
Post-intervention	90.4 (76.2 to 97.7)	91.0 (73.6 to 97.8)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected at 12-months post-intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DIABE-TEXT	0 of 0	2 of 371 (0.5%)	6 of 371
Usual Care	0 of 0	0 of 371 (0%)	2 of 371

Limitations and caveats (from the sponsor): 1. Difficulties in accurately measuring participant adherence due to message comprehension uncertainties and relay through caregivers, potentially diluting intervention reach. 2. Lack of intermediate evaluations during follow-up. 3. Lack of registration of social variables.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37995967Zamanillo-Campos R, Fiol-DeRoque MA, Serrano-Ripoll MJ, Mira-Martinez S, Llobera-Canaves J, Taltavull-Aparicio JM, Leiva-Rus A, Ripoll-Amengual J, Angullo-Martinez E, Socias-Buades IM, Masmiquel-Comas L, Konieczna J, Zaforteza-Dezcallar M, Boronat-Moreiro MA, Gervilla-Garcia E, Ricci-Cabello I. DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2024 Jan;136:107399. doi: 10.1016/j.cct.2023.107399. Epub 2023 Nov 22.

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DIABE-TEXT in people with Diabetes Mellitus, Type 2, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated Hemoglobin (HbA1c) (%) (time frame: Baseline and post-intervention at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05006872, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.