Type 1 DiabetesNCT06184815
Effectiveness of a Multidisciplinary Treatment and Structured Education Programme
A study testing Educational programme 12 and Standard education and treatment in people with Type 1 Diabetes, run by Instituto Mexicano del Seguro Social.
Trial summary
This trial compared an structured education programme and multidisciplinary treatment vs an standard treatment in type 1 diabetes patient, the Primary outcome is glycemic control at 6-month follow up and secondary outcome are cardiovascular risk factors control, diabetes related distress, anxiety and depressive… Read more about this study
- Who is it for?
- Ages 15 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Educational programme 12 and Standard education and treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Nov 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Diabetes duration >1 year
- BMI 18.5-40kg/m2
- A1c 6.5-13%
Who cannot join
- Pregnancy
- Dementia or severe cognitive impairment
- Uncontrolled psychiatric disorder
- Absence of >20% of the educational sessions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of a Multidisciplinary Treatment and Structured Education for Type 1 Diabetes Patients
This trial compared an structured education programme and multidisciplinary treatment vs an standard treatment in type 1 diabetes patient, the Primary outcome is glycemic control at 6-month follow up and secondary outcome are cardiovascular risk factors control, diabetes related distress, anxiety and depressive symptoms, hypoglycemia awareness.
Read the detailed description
Both groups will received individualized treatment in the clinic, the intervention group will consist of 12 educational sessions during 4 months, and multidisciplinary treatment each month given by endocrinology, nutrition and psychology during 4 months, the control group will received education in outpatient clinic of endocrinology and will be sent as referral to specialties of nutrition and psychology as standard follow-up of the clinic.
- Conditions
- Type 1 Diabetes
- Being tested
- Educational programme 12, Standard education and treatment
- Keywords
- type 1 diabetes, Autoimmune Diseases, Diabetes, Education Programme, DSMES, Diabetes self-management education and support, T1D, Insulin-dependent diabetes, Juvenile diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Autoimmune Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programme 12Behavioural
Consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months and multidisciplinary treatment
Standard education and treatmentBehavioural
Also called Standard
Outpatient management and education in the office and consultation referral to nutrition and psychology
| Study group | Role | What they receive |
|---|---|---|
| Educational programme 12 | Experimental | The educational programme consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months. The multidisciplinary treatment consists of 4, each one every month, consultations of specialties of nutrition, endocinrology and psychology. Receives: Behavioral: Educational programme 12 |
| Standard | Active comparator | The standard educational program consists of outpatient management with diabetic education slides and material for the patient, with a duration of 4 months. Standard treatment consists of endocrinology consultation with nutrition and psychology referral if required Receives: Behavioral: Standard education and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Glycemic Control Measured by A1c
Difference between baseline A1c and A1c at 6 month follow up
Measured: Baseline and 6 months
Secondary outcomes (5)
Changes in Lipid Control Measured by LDLc, HDLc, non-HDLc, Triglycerides, Total Cholesterol
Difference between basal lipid profile and lipid profile at 6 month follow up
Measured: Baseline and 6 months
Changes in insulin resistance control Measured by eGDR
Difference between basal eGDR and eGDR at 6 month follow up
Measured: Baseline and 6 months
Changes in Mental health Measured by DDS, GAD7 and PHQ9
Difference between basal DDS, GAD7 and PHQ9 and DDS, GAD7 and PHQ9 at 6 month follow up
Measured: Baseline and 6 months
Changes Anthropometry Measured by BMI and WC
Difference between basal BMI and WC and BMI and WC at 6 months
Measured: Baseline and 6 months
Changes in Glycemic Control Measured by severe hypoglycemia
Difference between severe hypoglycemia in the las 6 months and severe hypoglycemia at 6 months of follow up
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The educational programme consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months. The multidisciplinary treatment consists of 4, each one every month, consultations of specialties of nutrition, endocinrology and psychology.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Sanchez Garcia, Instituto Mexicano del Seguro Social
- Investigators
- David Sanchez, MD, Principal investigator, Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25 Monterrey, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184815
- Sponsor's protocol ID
- IMSST1D
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multidisciplinary Treatment and Structured Education for Type 1 Diabetes Patients
- ClinicalTrials.gov ID
- NCT06184815
- Acronym / sponsor ID
- IMSST1D
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, Autoimmune Diseases, Diabetes, Education Programme, DSMES, Diabetes self-management education and support, T1D, Insulin-dependent diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 28 Dec 2023 (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 trial compared an structured education programme and multidisciplinary treatment vs an standard treatment in type 1 diabetes patient, the Primary outcome is glycemic control at 6-month follow up and secondary outcome are cardiovascular risk factors control, diabetes related distress, anxiety and depressive symptoms, hypoglycemia awareness.
Detailed description
Both groups will received individualized treatment in the clinic, the intervention group will consist of 12 educational sessions during 4 months, and multidisciplinary treatment each month given by endocrinology, nutrition and psychology during 4 months, the control group will received education in outpatient clinic of endocrinology and will be sent as referral to specialties of nutrition and psychology as standard follow-up of the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The educational programme consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months. The multidisciplinary treatment consists of 4, each one every month, consultations of specialties of nutrition, endocinrology and psychology.
| Arm | Type | Receives |
|---|---|---|
| Educational programme 12 | Experimental | Behavioral: Educational programme 12The educational programme consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months. The multidisciplinary treatment consists of 4, each one every month, consultations of specialties of nutrition, endocinrology and psychology. |
| Standard | Active comparator | Behavioral: Standard education and treatmentThe standard educational program consists of outpatient management with diabetic education slides and material for the patient, with a duration of 4 months. Standard treatment consists of endocrinology consultation with nutrition and psychology referral if required |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes
- Diabetes duration >1 year
- BMI 18.5-40kg/m2
- A1c 6.5-13%
Key exclusion criteria (4 listed)
- Pregnancy
- Dementia or severe cognitive impairment
- Uncontrolled psychiatric disorder
- Absence of >20% of the educational sessions
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 |
|---|---|---|
| Educational programme 12Consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months and multidisciplinary treatment | Behavioural | Educational programme 12 |
| Standard education and treatmentAlso: StandardOutpatient management and education in the office and consultation referral to nutrition and psychology | Behavioural | Standard |
Primary outcome
Changes in Glycemic Control Measured by A1c
Time frame: Baseline and 6 months
Difference between baseline A1c and A1c at 6 month follow up
5 secondary outcomes
Changes in Lipid Control Measured by LDLc, HDLc, non-HDLc, Triglycerides, Total Cholesterol
Time frame: Baseline and 6 months
Changes in insulin resistance control Measured by eGDR
Time frame: Baseline and 6 months
Changes in Mental health Measured by DDS, GAD7 and PHQ9
Time frame: Baseline and 6 months
Changes Anthropometry Measured by BMI and WC
Time frame: Baseline and 6 months
Changes in Glycemic Control Measured by severe hypoglycemia
Time frame: Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
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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.
David Sanchez, MD principal investigator
Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25 Monterrey, Mexico
Questions about this trial
What is this clinical trial studying?
A study testing Educational programme 12 and Standard education and treatment in people with Type 1 Diabetes, run by Instituto Mexicano del Seguro Social.
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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Sanchez, MD (8183714100 ext. 41315, davidsanchez70@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Glycemic Control Measured by A1c (time frame: Baseline and 6 months). 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 28 Dec 2023.