Type 1 Diabetes MellitusASKED-ITNCT03241212
Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting
A study testing Texting in people with Type 1 Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3 months and 6 months. Read more about this study
- Who is it for?
- Ages 15 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Texting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2017to 14 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of type 1 diabetes mellitus
- Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)
- Age 15-20 at study enrollment
- English literate and English speaking
- Ability to complete the required surveys
- Have a personal cell phone with service compatible with EZTexting Platform
- Able to provide informed assent or consent (if 18 years of age or older) and parental informed consent (if needed).
Who cannot join
- Not planning to continue care in the pediatric clinic at BDC for at least the next 6 months.
- Diabetes Diagnosis other than Type 1 Diabetes
- Inability for the adolescent to respond to text messages (e.g. due to developmental delay)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting (ASKED-IT)
This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3 months and 6 months. The intervention group will receive a minimum of 78 text messages related to diabetes over the course of 26 weeks from study enrollment. Subjects are invited to respond to some text messages which will be in the form of a multiple-choice question and if they do, they will receive an additional text message in response to their answer.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Texting
- Keywords
- adolescent, young adult, knowledge, self-care
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TextingBehavioural
From baseline appointment to 6 month follow up, those participants randomly assigned to the texting intervention will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | At baseline enrollment: participants will be asked to fill out a demographic survey, the MWIKAD survey and the SMOD-A survey. HbA1c, frequency of Blood Glucose (BG) checks and percent of glucose values above, within and below the target range will be extracted from chart review. Surveys (with the exception of demographics) and chart extraction will be repeated at 3 months and 6 months post enrollment. |
| Texting | Experimental | Participants will be asked to complete the same surveys on the same timeline as above. The texting group will be asked to provide their cell phone number to the texting software.
From baseline appointment to 26 weeks post enrollment, participants will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen. Receives: Behavioral: Texting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge about type 1 diabetes
Measured by the Mercy-What I Know About Diabetes Test (MWIKAD)
Measured: 6 months from intervention
Secondary outcomes (5)
Change in diabetes self-care practices
Assessed by the Self-Management of Type 1 Diabetes in Adolescents (SMOD-A) tool
Measured: at 3 months and 6 months
Change in Hemoglobin A1c
Measured: at 3 months and 6 months
Change in blood glucose testing frequency
Measured: at 3 months and 6 months
Change in percent of blood glucoses high, in range and low
Measured: at 3 months and 6 months
Percent of text messages responded to in the study.
Measured: After 6 months of texting intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start12 Sep 2017
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonalee Ravi, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241212
- Sponsor's protocol ID
- 17-1135
- Acronym
- ASKED-IT
- Status last verified
- May 2019
- First submitted
- 2 Aug 2017
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting (ASKED-IT)
- ClinicalTrials.gov ID
- NCT03241212
- Acronym / sponsor ID
- ASKED-IT / 17-1135
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- adolescent, young adult, knowledge, self-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3 months and 6 months. The intervention group will receive a minimum of 78 text messages related to diabetes over the course of 26 weeks from study enrollment. Subjects are invited to respond to some text messages which will be in the form of a multiple-choice question and if they do, they will receive an additional text message in response to their answer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –At baseline enrollment: participants will be asked to fill out a demographic survey, the MWIKAD survey and the SMOD-A survey. HbA1c, frequency of Blood Glucose (BG) checks and percent of glucose values above, within and below the target range will be extracted from chart review. Surveys (with the exception of demographics) and chart extraction will be repeated at 3 months and 6 months post enrollment. |
| Texting | Experimental | Behavioral: TextingParticipants will be asked to complete the same surveys on the same timeline as above. The texting group will be asked to provide their cell phone number to the texting software. From baseline appointment to 26 weeks post enrollment, participants will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen. |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosis of type 1 diabetes mellitus
- Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)
- Age 15-20 at study enrollment
- English literate and English speaking
- Ability to complete the required surveys
Key exclusion criteria (3 listed)
- Not planning to continue care in the pediatric clinic at BDC for at least the next 6 months.
- Diabetes Diagnosis other than Type 1 Diabetes
- Inability for the adolescent to respond to text messages (e.g. due to developmental delay)
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 |
|---|---|---|
| TextingFrom baseline appointment to 6 month follow up, those participants randomly assigned to the texting intervention will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen. | Behavioural | Texting |
Primary outcome
Change in knowledge about type 1 diabetes
Time frame: 6 months from intervention
Measured by the Mercy-What I Know About Diabetes Test (MWIKAD)
5 secondary outcomes
Change in diabetes self-care practices
Time frame: at 3 months and 6 months
Change in Hemoglobin A1c
Time frame: at 3 months and 6 months
Change in blood glucose testing frequency
Time frame: at 3 months and 6 months
Change in percent of blood glucoses high, in range and low
Time frame: at 3 months and 6 months
Percent of text messages responded to in the study.
Time frame: After 6 months of texting intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Sonalee Ravi, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Texting in people with Type 1 Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
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 7 inclusion and 3 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 3 Jun 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in knowledge about type 1 diabetes (time frame: 6 months from intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.