Comprehensive Care in Type 1 Diabetes and Associated Outcomes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: Diabetes Disease Management Program; Other: Usual Care Process

• Registration Number: NCT03835195
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-06-01
• Status Verified: 2019-01
• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-08
• Primary Completion: 2019-02-28
• Study Completion: 2019-03-28
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Disease Management Program	Diabetes Disease Management Program	Diabetes Disease Management Program
Usual Care Process	Usual Care Process	Usual care process

Primary Outcome Measures

Name	Time	Method
Differences in HbA1C value after the intervention	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

Name	Time	Method
Number of hospitalizations associated with diabetes, after the intervention	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.
Difference in the body mass index after the intervention	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.
Proportion of patients diagnosed with dyslipidemia after the intervention	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.
Proportion of patients with hypoglycaemia after the intervention	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.
Proportion of patients diagnosed with hypertension after the intervention	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.

Trial Locations

Locations (1)

Clínica Integral de Diabetes; 🇨🇴 Medellín, Antioquia, Colombia