Type 1 Diabetes Mellitus3MsNCT03168867
Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
A study testing The 3Ms Intervention in people with Type 1 Diabetes Mellitus, run by Wayne State University at 7 sites in United States.
Trial summary
The purpose of the study is to conduct a multicenter, randomized effectiveness trial of The 3Ms. The proposed study will use an effectiveness-implementation "Hybrid 1" design. In this design, the primary goal is to determine whether an intervention works in a real-world setting, but the design also answers secondary… Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- The 3Ms Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Sep 2017to 3 Aug 2021
- 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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 10 years 0 months - 15 years, 11 months
- Diagnosed with Type 1 diabetes
- Diagnosed for at least 6 months
- African American
- Residence within 30 miles of a recruitment site (Children's Hospital of Michigan, Ann and Robert H. Lurie Children's Hospital of Chicago, Children's Hospital University of Illinois, or La Rabida Children's Hospital of Chicago)
- Primary caregiver willing to participate
Who cannot join
- Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality)
- Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)
- Inability to speak or read English
- Child is in out-of-home placement
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Children's Hospital University of Illinois
Chicago, Illinois, 60612
UChicago Medicine Comer Children's Hospital
Chicago, Illinois, 60637
La Rabida Children's Hospital
Chicago, Illinois, 60649
Children's Hospital of Michigan
Detroit, Michigan, 48201
Ascension St. John Children's Hospital
Detroit, Michigan, 48236
William Beaumont Children's Hospital
Royal Oak, Michigan, 48073
About this study
The purpose of the study is to conduct a multicenter, randomized effectiveness trial of The 3Ms. The proposed study will use an effectiveness-implementation "Hybrid 1" design. In this design, the primary goal is to determine whether an intervention works in a real-world setting, but the design also answers secondary questions such as the relationship between treatment dose and treatment outcome and what factors affect the actual delivery of the intervention in the clinics (staff burden, workflow interference etc).
Read the detailed description
The study will be conducted at 3 clinics in the Detroit area (Children's Hospital of Michigan (CHM); Ascension St. John Children's Hospital; William Beaumont Children's Hospital) and 4 clinics in the Chicago area. Wayne State University (WSU) will function as the coordinating center for the trial and will be responsible for overseeing the adequacy all aspects of trial management, including recruitment, retention, data collection, data management and statistical analyses. 212 African American (AA) adolescents with type 1 diabetes and their primary caregivers will be enrolled across all sites (half will be enrolled at WSU and half at the 4 Chicago sites). Families will be randomized to one of two arms: The 3Ms intervention (parental motivation for supervision of adolescent DSM) or standard educational control. In the 3Ms condition, parents will receive a brief (10-20 minute) computer delivered intervention at three consecutive routine diabetes clinic visits that is designed to increase parental motivation to supervise adolescent diabetes management. In the control condition, parents will receive computer-delivered education materials regarding type 1 diabetes. Data collection will be completed in the diabetes clinic at baseline and then at 6, 12 and 18 months after baseline in the families' home. Data collection is completed by the adolescent and caregiver on a tablet computer and includes questionnaires to assess adolescent diabetes management, parental supervision of diabetes management, family relationships and youth quality of life. Blood will also be collected to measure HbA1c (mean blood glucose level). Medical record data will also be collected. The data analyses will be intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data will analyzed using the linear mixed effect model (LME) for repeated measures.
In addition to the clinical trial, 20 diabetes clinic staff members (5 at WSU from the CHM clinic; 15 from the Chicago clinics) will also be recruited to participate in qualitative interviews upon completion of the trial. The purpose of the interview is to identify barriers and facilitators of use of the 3Ms intervention at the level of the individual clinician, the diabetes clinic and the organization (hospital). Interviews will be audiotaped and subsequently transcribed for coding.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- The 3Ms Intervention
- Keywords
- insulin dependent diabetes mellitus, adolescents/young adults, e-health intervention, parental monitoring
- 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.
The 3Ms InterventionBehavioural
The 3 Ms is a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporates principles of Motivational Interviewing. The goal of the 3 Ms intervention is to increase caregiver motivation to supervise children's daily diabetes care. The intervention consists of 3 brief sessions that are delivered at routine diabetes clinic appointments.
| Study group | Role | What they receive |
|---|---|---|
| Standard Educational Control | No intervention | Participants in the standard educational control group will be provided with standard care regarding type 1 diabetes management during their routine clinic visits as usual. The standard care will be consistent with diabetes education provided by each of the study sites. |
| The 3Ms Intervention + Standard Care | Experimental | Parents will complete the first intervention session in the diabetes clinic immediately after baseline data collection and randomization. The subsequent two intervention sessions will also be conducted during regularly scheduled diabetes clinic visits. Receives: Behavioral: The 3Ms Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
Hemoglobin A1c (HbA1c)
Measured: Baseline, 6, 13 and 18 month follow-up
Secondary outcomes (9)
Regimen Adherence (Objective)
Glucose Meter (frequency of testing)
Measured: Baseline, 6 months, 13 months, and 18 months
Diabetes Management (Self-reported)
Diabetes Management Scale (DMS)
Measured: Baseline, 6 months, 13 months, and 18 months
Parental Monitoring of Diabetes Care (Self-reported)
The Parental Monitoring of Diabetes Care-Revised (PMDC-R)
Measured: Baseline, 6 months, 13 months, and 18 months
Diabetes- Specific Family Functioning (Self-reported)
Diabetes Family Conflict Scale (DFCS-R)
Measured: Baseline, 6 months, 13 months, and 18 months
Adolescent Depression (Self-reported)
Patient Reported Outcomes Measurement Information System (PROMIS)
Measured: Baseline, 6 months, 13 months, and 18 months
Executive Functioning (Self-reported)
Behavior Rating Inventory of Executive Function (BRIEF)
Measured: Baseline, 6 months, 13 months, and 18 months
Cost Analysis (Self-reported)
EuroQol five-dimensional (EQ-5D)
Measured: Baseline, 6 months, 13 months, and 18 months
Diabetes Emotional Distress (Self-reported)
Problem Areas in Diabetes (PAID)
Measured: Baseline, 6 months, 13 months, and 18 months
Household Chaos (Self-reported)
Confusion, Hubbub, and Order Scale (CHAOS)
Measured: Baseline, 6 months, 13 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start25 Sep 2017
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
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 (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Ellis, Ph.D., Wayne State University
- Investigators
- Deborah A Ellis, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168867
- Sponsor's protocol ID
- 015117B3E
- Other IDs
- R01DK110075, 1R01DK110075-01A1
- Acronym
- 3Ms
- Status last verified
- Apr 2023
- First submitted
- 24 May 2017
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knauft KM, Jacques-Tiura AJ, Carcone AI, Evans MA, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab MB, Ellis D. Blood Glucose Levels and Diabetes Family Conflict in Black Adolescents with Type 1 Diabetes During the COVID-19 Pandemic. Behav Med. 2026 Apr-Jun;52(2):135-149. doi: 10.1080/08964289.2025.2543265. Epub 2025 Aug 27.
PubMed 40859913Knauft KM, Jacques-Tiura AJ, Idalski Carcone A, Evans M, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab B, Ellis DA. The moderating role of diabetes distress on the effect of a randomized eHealth intervention on glycemic control in Black adolescents with type 1 diabetes. J Pediatr Psychol. 2024 Aug 1;49(8):538-546. doi: 10.1093/jpepsy/jsae033.
PubMed 38775162Ellis D, Carcone AI, Templin T, Evans M, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab MB. Moderating Effect of Depression on Glycemic Control in an eHealth Intervention Among Black Youth With Type 1 Diabetes: Findings From a Multicenter Randomized Controlled Trial. JMIR Diabetes. 2024 Apr 9;9:e55165. doi: 10.2196/55165.
PubMed 38593428
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
- ClinicalTrials.gov ID
- NCT03168867
- Acronym / sponsor ID
- 3Ms / 015117B3E
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- insulin dependent diabetes mellitus, adolescents/young adults, e-health intervention, parental monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to conduct a multicenter, randomized effectiveness trial of The 3Ms. The proposed study will use an effectiveness-implementation "Hybrid 1" design. In this design, the primary goal is to determine whether an intervention works in a real-world setting, but the design also answers secondary questions such as the relationship between treatment dose and treatment outcome and what factors affect the actual delivery of the intervention in the clinics (staff burden, workflow interference etc).
Detailed description
The study will be conducted at 3 clinics in the Detroit area (Children's Hospital of Michigan (CHM); Ascension St. John Children's Hospital; William Beaumont Children's Hospital) and 4 clinics in the Chicago area. Wayne State University (WSU) will function as the coordinating center for the trial and will be responsible for overseeing the adequacy all aspects of trial management, including recruitment, retention, data collection, data management and statistical analyses. 212 African American (AA) adolescents with type 1 diabetes and their primary caregivers will be enrolled across all sites (half will be enrolled at WSU and half at the 4 Chicago sites). Families will be randomized to one of two arms: The 3Ms intervention (parental motivation for supervision of adolescent DSM) or standard educational control. In the 3Ms condition, parents will receive a brief (10-20 minute) computer delivered intervention at three consecutive routine diabetes clinic visits that is designed to increase parental motivation to supervise adolescent diabetes management. In the control condition, parents will receive computer-delivered education materials regarding type 1 diabetes. Data collection will be completed in the diabetes clinic at baseline and then at 6, 12 and 18 months after baseline in the families' home. Data collection is completed by the adolescent and caregiver on a tablet computer and includes questionnaires to assess adolescent diabetes management, parental supervision of diabetes management, family relationships and youth quality of life. Blood will also be collected to measure HbA1c (mean blood glucose level). Medical record data will also be collected. The data analyses will be intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data will analyzed using the linear mixed effect model (LME) for repeated measures.
In addition to the clinical trial, 20 diabetes clinic staff members (5 at WSU from the CHM clinic; 15 from the Chicago clinics) will also be recruited to participate in qualitative interviews upon completion of the trial. The purpose of the interview is to identify barriers and facilitators of use of the 3Ms intervention at the level of the individual clinician, the diabetes clinic and the organization (hospital). Interviews will be audiotaped and subsequently transcribed for coding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Educational Control | No intervention | –Participants in the standard educational control group will be provided with standard care regarding type 1 diabetes management during their routine clinic visits as usual. The standard care will be consistent with diabetes education provided by each of the study sites. |
| The 3Ms Intervention + Standard Care | Experimental | Behavioral: The 3Ms InterventionParents will complete the first intervention session in the diabetes clinic immediately after baseline data collection and randomization. The subsequent two intervention sessions will also be conducted during regularly scheduled diabetes clinic visits. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age: 10 years 0 months - 15 years, 11 months
- Diagnosed with Type 1 diabetes
- Diagnosed for at least 6 months
- African American
- Residence within 30 miles of a recruitment site (Children's Hospital of Michigan, Ann and Robert H. Lurie Children's Hospital of Chicago, Children's Hospital University of Illinois, or La Rabida Children's Hospital of Chicago)
Key exclusion criteria (4 listed)
- Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality)
- Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)
- Inability to speak or read English
- Child is in out-of-home placement
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 |
|---|---|---|
| The 3Ms InterventionThe 3 Ms is a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporates principles of Motivational Interviewing. The goal of the 3 Ms intervention is to increase caregiver motivation to supervise children's daily diabetes care. The intervention consists of 3 brief sessions that are delivered at routine diabetes clinic appointments. | Behavioural | The 3Ms Intervention + Standard Care |
Primary outcome
Glycemic Control
Time frame: Baseline, 6, 13 and 18 month follow-up
Hemoglobin A1c (HbA1c)
9 secondary outcomes
Regimen Adherence (Objective)
Time frame: Baseline, 6 months, 13 months, and 18 months
Diabetes Management (Self-reported)
Time frame: Baseline, 6 months, 13 months, and 18 months
Parental Monitoring of Diabetes Care (Self-reported)
Time frame: Baseline, 6 months, 13 months, and 18 months
Diabetes- Specific Family Functioning (Self-reported)
Time frame: Baseline, 6 months, 13 months, and 18 months
Adolescent Depression (Self-reported)
Time frame: Baseline, 6 months, 13 months, and 18 months
Executive Functioning (Self-reported)
Time frame: Baseline, 6 months, 13 months, and 18 months
Cost Analysis (Self-reported)
Time frame: Baseline, 6 months, 13 months, and 18 months
Diabetes Emotional Distress (Self-reported)
Time frame: Baseline, 6 months, 13 months, and 18 months
Household Chaos (Self-reported)
Time frame: Baseline, 6 months, 13 months, and 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40859913Knauft KM, Jacques-Tiura AJ, Carcone AI, Evans MA, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab MB, Ellis D. Blood Glucose Levels and Diabetes Family Conflict in Black Adolescents with Type 1 Diabetes During the COVID-19 Pandemic. Behav Med. 2026 Apr-Jun;52(2):135-149. doi: 10.1080/08964289.2025.2543265. Epub 2025 Aug 27.
- Derived from this study: PubMed 38775162Knauft KM, Jacques-Tiura AJ, Idalski Carcone A, Evans M, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab B, Ellis DA. The moderating role of diabetes distress on the effect of a randomized eHealth intervention on glycemic control in Black adolescents with type 1 diabetes. J Pediatr Psychol. 2024 Aug 1;49(8):538-546. doi: 10.1093/jpepsy/jsae033.
- Derived from this study: PubMed 38593428Ellis D, Carcone AI, Templin T, Evans M, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab MB. Moderating Effect of Depression on Glycemic Control in an eHealth Intervention Among Black Youth With Type 1 Diabetes: Findings From a Multicenter Randomized Controlled Trial. JMIR Diabetes. 2024 Apr 9;9:e55165. doi: 10.2196/55165.
- 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.
Deborah A Ellis, Ph.D. principal investigator
Wayne State University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The 3Ms Intervention in people with Type 1 Diabetes Mellitus, run by Wayne State University at 7 sites 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 6 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 18 Apr 2023). 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?
Glycemic Control (time frame: Baseline, 6, 13 and 18 month follow-up). 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 NCT03168867, which also lists 3 linked publications.
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 18 Apr 2023.