Diabetes Mellitus, Type 1NCT02927639

MyDiaText Text Messaging Intervention for Diabetes

A study testing MyDiaText in people with Diabetes Mellitus, Type 1, run by Children's Hospital of Philadelphia at 1 site in United States.

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

Who is it for?: Ages 12 to 18 years
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: MyDiaText
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 166 participants
Where: 1 siteUnited States
Study dates: 31 Jul 2018to 1 Oct 2019
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 12 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Diagnosis of type 1 diabetes for more than 1 year
HbA1c greater than or equal to 8% but less than 14%.
Have been seen in diabetes clinic in the last 6 months
Owns a personal mobile device with unlimited text messaging plan

Who cannot join

Non-English speaking
Significant cognitive disability or major organ illness
Hemolytic anemia

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: MyDiaText: Texting the Way to Better Diabetes Control

To test a text messaging intervention using MyDiaText and financial incentives to determine whether such an intervention will improve self-reported self-care behaviors in children 12 to 18 years old. The intervention will consist of daily text messages sent to the subject's personal mobile device. Subjects will be incentivized to respond to text messages via a lottery financial incentive. Previously developed text messages based on the American Diabetes Association (ADA) behavior goals will be used for this intervention.

Conditions: Diabetes Mellitus, Type 1
Being tested: MyDiaText
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.

MyDiaTextOther
The intervention will consist of daily text messages sent to the subject's personal mobile device.

Study groups in NCT02927639
Study group	Role	What they receive
Intervention	Experimental	This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention. Receives: Other: MyDiaText
Control	No intervention	This group will receive the usual standard of care for 6 months.

What is being measured

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

Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months
Estimate of self-management will be assessed via the Self-Care Inventory questionnaire. This scale measures self-reported adherence to diabetes self-care behaviors. A higher score on 1-5 scale is associated with more self care behaviors, i.e., better outcomes. The outcome was mean score on the scale. If a participant responded N/A, this question was not included in calculation of mean score.
Measured: 6 months

Secondary outcomes (1)

Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months
Hemoglobin A1c is a measure of glycemic control scale that reflects how well they followed recommendations for self-care during the past month (1="never do it" to 5 ="always do this as recommended, without fail"). Total scores range from 1-70 and previous data shows that youth with better self-care levels (higher scores) have significantly better glycemic control.
Measured: 6 months

Timeline

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

31 Jul 20181 Oct 2019

First posted7 Oct 2016 (estimated)
Study start31 Jul 2018
Primary completion1 Oct 2019
Study completion1 Oct 2019

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.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02927639
Sponsor's protocol ID: 16-013222
Other IDs: T32DK063688-13S1
Status last verified: May 2021
First submitted: 6 Oct 2016
Last updated: 9 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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 recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
Diabetes Mellitus, Type 1
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes

All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MyDiaText: Texting the Way to Better Diabetes Control
ClinicalTrials.gov ID: NCT02927639
Acronym / sponsor ID: 16-013222
Conditions: Diabetes Mellitus, Type 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 31 Jul 2018 (actual)
Primary completion: 1 Oct 2019 (actual)
Study completion: 1 Oct 2019 (actual)
First posted: 7 Oct 2016 (estimated)
Results: Posted 20 Nov 2020

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Other: MyDiaTextThis group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention.
Control	No intervention	–This group will receive the usual standard of care for 6 months.

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Diagnosis of type 1 diabetes for more than 1 year
HbA1c greater than or equal to 8% but less than 14%.
Have been seen in diabetes clinic in the last 6 months
Owns a personal mobile device with unlimited text messaging plan

Key exclusion criteria (3 listed)

Non-English speaking
Significant cognitive disability or major organ illness
Hemolytic anemia

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
MyDiaTextThe intervention will consist of daily text messages sent to the subject's personal mobile device.	Other	Intervention

Primary outcome

Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months
Time frame: 6 months
Estimate of self-management will be assessed via the Self-Care Inventory questionnaire. This scale measures self-reported adherence to diabetes self-care behaviors. A higher score on 1-5 scale is associated with more self care behaviors, i.e., better outcomes. The outcome was mean score on the scale. If a participant responded N/A, this question was not included in calculation of mean score.

1 secondary outcome

Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months
Time frame: 6 months

Results and safety

Results posted to the registry on 20 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	83	10
Control	82	13

Primary outcome: Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months

Time frame: 6 months. Mean (Standard Error). Unit: score on a scale

Measure	Intervention n = 65	Control n = 70
Value	3.57 (0.07)	3.62 (0.07)

Intervention vs Control: p = 0.035, Mixed Models Analysis

Population analysed: Those analyzed were those who completed at least 1 self-care inventory survey. Analysis was preformed using multilevel mixed effects linear regression model. Outcomes are model-predicted.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 0	0 of 83 (0%)	0
Control	0 of 0	0 of 82 (0%)	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diabetes Mellitus, Type 1

Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
Diabetes Mellitus, Type 1
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes

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.

Terri Lipman, PhD principal investigator

CHOP

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

Questions about this trial

What is this clinical trial studying?

A study testing MyDiaText in people with Diabetes Mellitus, Type 1, run by Children's Hospital of Philadelphia 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 4 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 9 Jun 2021. 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?

Yes. Results are posted in the registry (first posted 20 Nov 2020). 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?

Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months (time frame: 6 months). 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 NCT02927639.

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 9 Jun 2021.