Comprehensive Care in Type 1 Diabetes and Associated Outcomes (AIDDA)
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Diabetes Disease Management Program
Usual Care Process
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- 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%.
Exclusion Criteria:
- Patients who at the time of recruitment were treated with continuous insulin infusion device (insulin pump) and patients with gestational diabetes were excluded.
Sites / Locations
- Clínica Integral de Diabetes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diabetes Disease Management Program
Usual Care Process
Arm Description
Diabetes Disease Management Program
Usual care process
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03835195
First Posted
February 4, 2019
Last Updated
June 5, 2019
Sponsor
Universidad de Antioquia
1. Study Identification
Unique Protocol Identification Number
NCT03835195
Brief Title
Comprehensive Care in Type 1 Diabetes and Associated Outcomes
Acronym
AIDDA
Official Title
Comprehensive Care in Type 1 Diabetes and Associated Outcomes: AIDDA: a Quasiexperimental Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
March 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Antioquia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 - 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetes Disease Management Program
Arm Type
Experimental
Arm Description
Diabetes Disease Management Program
Arm Title
Usual Care Process
Arm Type
Active Comparator
Arm Description
Usual care process
Intervention Type
Other
Intervention Name(s)
Diabetes Disease Management Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care Process
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences in HbA1C value after the intervention
Description
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.
Time Frame
4-9 months
Secondary Outcome Measure Information:
Title
Proportion of patients diagnosed with dyslipidemia after the intervention
Description
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.
Time Frame
4-9 months
Title
Proportion of patients with hypoglycaemia after the intervention
Description
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.
Time Frame
4-9 months
Title
Number of hospitalizations associated with diabetes, after the intervention
Description
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.
Time Frame
4-9 months
Title
Proportion of patients diagnosed with hypertension after the intervention
Description
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.
Time Frame
4-9 months
Title
Difference in the body mass index after the intervention
Description
The measure corresponds to the records in the admission consultation (before) and in the consultation at 4-9 months (after) in the institution.
Time Frame
4-9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%.
Exclusion Criteria:
Patients who at the time of recruitment were treated with continuous insulin infusion device (insulin pump) and patients with gestational diabetes were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Jairo Zuleta Tobón, MD, Msc
Organizational Affiliation
Universidad de Antioquia
Official's Role
Study Director
Facility Information:
Facility Name
Clínica Integral de Diabetes
City
Medellín
State/Province
Antioquia
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
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Comprehensive Care in Type 1 Diabetes and Associated Outcomes
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