Comprehensive Care in Type 1 Diabetes and Associated Outcomes

NCT03835195 | Completed

• 1 other identifier: AIDDA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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.

  4-9 months

Secondary Outcomes (5)

• Proportion of patients diagnosed with dyslipidemia after the intervention

  4-9 months

• Proportion of patients with hypoglycaemia after the intervention

  4-9 months

• Number of hospitalizations associated with diabetes, after the intervention

  4-9 months

• Proportion of patients diagnosed with hypertension after the intervention

  4-9 months

• Difference in the body mass index after the intervention

  4-9 months

Study Arms (2)

Diabetes Disease Management Program

EXPERIMENTAL

Diabetes Disease Management Program

Other: Diabetes Disease Management Program

Usual Care Process

ACTIVE COMPARATOR

Usual care process

Other: Usual Care Process

Interventions

Diabetes Disease Management Program OTHER

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.

Diabetes Disease Management Program

Usual Care Process OTHER

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.

Usual Care Process

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• Patients who at the time of recruitment were treated with continuous insulin infusion device (insulin pump) and patients with gestational diabetes were excluded.

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Clínica Integral de Diabetes

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John Jairo Zuleta Tobón, MD, Msc

  Universidad de Antioquia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 8, 2019
• Study Start: June 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 28, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)