Diabetes Mellitus, Type 1AIDDANCT03835195
Comprehensive Care in Type 1 Diabetes and Associated Outcomes
A study testing Diabetes Disease Management Program in people with Diabetes Mellitus, Type 1, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Quasi-experimental, retrospective, before and after study, with a control group, to evaluate the effect of an intervention based on disease management, on metabolic control and hospitalizations, in a group of patients with type Diabetes 1, attended in a Provider Institution of Health Services of the city of Medellin … Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Diabetes Disease Management Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jun 2018to 28 Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with type 1 diabetes.
- Patients affiliated to the Entity Administrator of Health Benefits Plans (EPS Sura)
- Patients with age greater than or equal to 15 years, who had been referred to the institution at the discretion of the treating physician, for poor metabolic control and had to enter a hemoglobin glycated (HbA1C) ≥ 7.0%.
Who cannot join
- Patients who at the time of recruitment were treated with continuous insulin infusion device (insulin pump) and patients with gestational diabetes were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Care in Type 1 Diabetes and Associated Outcomes: AIDDA: a Quasiexperimental Study.
Quasi-experimental, retrospective, before and after study, with a control group, to evaluate the effect of an intervention based on disease management, on metabolic control and hospitalizations, in a group of patients with type Diabetes 1, attended in a Provider Institution of Health Services of the city of Medellin - Colombia.
Read the detailed description
Evaluate the effect of an intervention based on the management of the disease, on metabolic control and the number of hospitalizations related to diabetes, in a group of patients with Type 1 Diabetes attended in a specialized Health Services Provider Institution in the city of Medellin - Colombia.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Diabetes Disease Management Program, Usual Care Process
- 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.
Diabetes Disease Management ProgramOther
The attention is carried out in a single physical place, in the city of Medellin. The scheme of intervention in the comprehensive Diabetes Clinic is based on the concept of disease management. The intervention is composed of 5 phases, which apply to all the patients cared for in the institution (access, reception, entry, clinical consultation, management plan, education, pharmaceutical care). The healthcare team consists of 5 endocrinologists, an endocrinologist pediatrician, 7 general practitioners trained in diabetes, 5 pharmacists trained in diabetes and certified in education for patients with diabetes and 3 nutritionists.
Usual Care ProcessOther
The patients are treated in the cardiovascular risk clinic (general practitioners) of their Primary Healthcare Provider Institution or by specialists in internal medicine, pediatrics or endocrinology in the different Provider Institutions of Health Services of the insurance service network of health or in private doctors' offices assigned to the insurer. In some cases there is assisted consultation (general practitioner - specialist). There is no defined periodicity for follow-up; Appointments are assigned to need, according to the criteria of the treating physicians. In some cases there is remission to educational activities, not necessarily focused on type 1 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Disease Management Program | Experimental | Diabetes Disease Management Program Receives: Other: Diabetes Disease Management Program |
| Usual Care Process | Active comparator | Usual care process Receives: Other: Usual Care Process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in HbA1C value after the intervention
It was considered as a measure of the before. The last glycated hemoglobin of the patient before starting care in the health institution, when his measurement time was not more than 6 months.
Otherwise, the value of the first HbA1C measured in the first 15 days of admission to the health institution was considered, since it reflects the level of basal glycemic control, with which the patient was referred to the institution. The post-intervention measurement corresponded to the last HbA1C measured at 4-9 months of follow-up in the institution.
Measured: 4-9 months
Secondary outcomes (5)
Proportion of patients diagnosed with dyslipidemia after the intervention
The measurement of the previous one corresponded to the diagnosis of dyslipidemia reported in the patient's clinical history before starting care in the institution. The postintervention measurement corresponded to the diagnosis of dyslipidemia reported in the clinical history at 4-9 months.
Measured: 4-9 months
Proportion of patients with hypoglycaemia after the intervention
The measurement of the before, corresponded to the report of at least one hypoglycaemia in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the report of hypoglycaemia in the clinical history at 4-9 months.
The measurement of the previous one corresponded to the diagnosis of HBP reported in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the diagnosis of hypertension reported in the clinical history at 4-9 months.
Measured: 4-9 months
Number of hospitalizations associated with diabetes, after the intervention
The measurement of the before, corresponded to the number of hospitalizations associated with diabetes, in the year prior to admission to the institution. The measurement afterwards corresponded to the measurement of hospitalizations during the Clid follow-up and in the subsequent 6 months.
Measured: 4-9 months
Proportion of patients diagnosed with hypertension after the intervention
The measurement of the previous one corresponded to the diagnosis of High Blood Pressure reported in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the diagnosis of hypertension reported in the clinical history at 4-9 months.
Measured: 4-9 months
Difference in the body mass index after the intervention
The measure corresponds to the records in the admission consultation (before) and in the consultation at 4-9 months (after) in the institution.
Measured: 4-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Jun 2018
- Primary completion28 Feb 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Jairo Zuleta Tobón, MD, Msc, Study director, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835195
- Sponsor's protocol ID
- AIDDA
- Acronym
- AIDDA
- Status last verified
- Jan 2019
- First submitted
- 4 Feb 2019
- Last updated
- 6 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 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Care in Type 1 Diabetes and Associated Outcomes: AIDDA: a Quasiexperimental Study.
- ClinicalTrials.gov ID
- NCT03835195
- Acronym / sponsor ID
- AIDDA / AIDDA
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 8 Feb 2019 (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.
Quasi-experimental, retrospective, before and after study, with a control group, to evaluate the effect of an intervention based on disease management, on metabolic control and hospitalizations, in a group of patients with type Diabetes 1, attended in a Provider Institution of Health Services of the city of Medellin - Colombia.
Detailed description
Evaluate the effect of an intervention based on the management of the disease, on metabolic control and the number of hospitalizations related to diabetes, in a group of patients with Type 1 Diabetes attended in a specialized Health Services Provider Institution in the city of Medellin - Colombia.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Disease Management Program | Experimental | Other: Diabetes Disease Management ProgramDiabetes Disease Management Program |
| Usual Care Process | Active comparator | Other: Usual Care ProcessUsual care process |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with type 1 diabetes.
- Patients affiliated to the Entity Administrator of Health Benefits Plans (EPS Sura)
- Patients with age greater than or equal to 15 years, who had been referred to the institution at the discretion of the treating physician, for poor metabolic control and had to enter a hemoglobin glycated (HbA1C) ≥ 7.0%.
Key exclusion criteria (1 listed)
- Patients who at the time of recruitment were treated with continuous insulin infusion device (insulin pump) and patients with gestational diabetes were excluded.
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 |
|---|---|---|
| Diabetes Disease Management ProgramThe attention is carried out in a single physical place, in the city of Medellin. The scheme of intervention in the comprehensive Diabetes Clinic is based on the concept of disease management. The intervention is composed of 5 phases, which apply to all the patients cared for in the institution (access, reception, entry, clinical consultation, management plan, education, pharmaceutical care). The healthcare team consists of 5 endocrinologists, an endocrinologist pediatrician, 7 general practitioners trained in diabetes, 5 pharmacists trained in diabetes and certified in education for patients with diabetes and 3 nutritionists. | Other | Diabetes Disease Management Program |
| Usual Care ProcessThe patients are treated in the cardiovascular risk clinic (general practitioners) of their Primary Healthcare Provider Institution or by specialists in internal medicine, pediatrics or endocrinology in the different Provider Institutions of Health Services of the insurance service network of health or in private doctors' offices assigned to the insurer. In some cases there is assisted consultation (general practitioner - specialist). There is no defined periodicity for follow-up; Appointments are assigned to need, according to the criteria of the treating physicians. In some cases there is remission to educational activities, not necessarily focused on type 1 diabetes. | Other | Usual Care Process |
Primary outcome
Differences in HbA1C value after the intervention
Time frame: 4-9 months
It was considered as a measure of the before. The last glycated hemoglobin of the patient before starting care in the health institution, when his measurement time was not more than 6 months. Otherwise, the value of the first HbA1C measured in the first 15 days of admission to the health institution was considered, since it reflects the level of basal glycemic control, with which the patient was referred to the institution. The post-intervention measurement corresponded to the last HbA1C measured at 4-9 months of follow-up in the institution.
5 secondary outcomes
Proportion of patients diagnosed with dyslipidemia after the intervention
Time frame: 4-9 months
Proportion of patients with hypoglycaemia after the intervention
Time frame: 4-9 months
Number of hospitalizations associated with diabetes, after the intervention
Time frame: 4-9 months
Proportion of patients diagnosed with hypertension after the intervention
Time frame: 4-9 months
Difference in the body mass index after the intervention
Time frame: 4-9 months
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 6 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 1
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
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
John Jairo Zuleta Tobón, MD, Msc study director
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Disease Management Program in people with Diabetes Mellitus, Type 1, run by Universidad de Antioquia at 1 site in Colombia.
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 3 inclusion and 1 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 6 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 Colombia. 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?
Differences in HbA1C value after the intervention (time frame: 4-9 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 6 Jun 2019.