Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 2474 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

Comprehensive Care in Type 1 Diabetes and Associated Outcomes (AIDDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03835195
Recruitment Status : Completed
First Posted : February 8, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Universidad de Antioquia

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: Diabetes Disease Management Program Other: Usual Care Process Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comprehensive Care in Type 1 Diabetes and Associated Outcomes: AIDDA: a Quasiexperimental Study.
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : March 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Diabetes Disease Management Program
Diabetes Disease Management Program
Other: Diabetes Disease Management Program
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.

Active Comparator: Usual Care Process
Usual care process
Other: Usual Care Process
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 Measures :
  1. 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.



Secondary Outcome Measures :
  1. Proportion of patients diagnosed with dyslipidemia after the intervention [ Time Frame: 4-9 months ]
    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.

  2. Proportion of patients with hypoglycaemia after the intervention [ Time Frame: 4-9 months ]

    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.


  3. Number of hospitalizations associated with diabetes, after the intervention [ Time Frame: 4-9 months ]
    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.

  4. Proportion of patients diagnosed with hypertension after the intervention [ Time Frame: 4-9 months ]
    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.

  5. Difference in the body mass index after the intervention [ Time Frame: 4-9 months ]
    The measure corresponds to the records in the admission consultation (before) and in the consultation at 4-9 months (after) in the institution.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835195


Locations
Layout table for location information
Colombia
Clínica Integral de Diabetes
Medellín, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Investigators
Layout table for investigator information
Study Director: John Jairo Zuleta Tobón, MD, Msc Universidad de Antioquia

Layout table for additonal information
Responsible Party: Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT03835195     History of Changes
Other Study ID Numbers: AIDDA
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases