Effects of Nursing Diabetes Self-management Education
1 other identifier
interventional
176
0 countries
N/A
Brief Summary
A study protocol for analyze the influence of therapeutic education on the metabolic control of patients with type I diabetes. To measure the change in glucose levels, it will use the continuous glucose monitoring sensor that the patients have implanted. It will perform a data download prior and after to the educational intervention. An assessment of acquired knowledge will also be performed and it will be analyzed whether learning about their disease and self-care helps to improve their emotional state. The intervention of this study is only training with therapeutic education, it does not require any type of extra test or medical or pharmacological product. It will only be necessary to answer attitudinal questionnaires by the patient
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2021
CompletedFirst Posted
Study publicly available on registry
December 16, 2021
CompletedStudy Start
First participant enrolled
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedDecember 16, 2021
December 1, 2021
5 months
November 22, 2021
December 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knowledge in diabetes management
Measure by pre-test and post-test
3 months
Secondary Outcomes (3)
Glycemic control
3 months
Healthy diet and physical exercise
3 months
Mood of patient
3 months
Study Arms (2)
Diabetes Self-Management education
EXPERIMENTALParticipants randomized to this arm receive therapeutic education during four sessions of four consecutive days. An advanced practice nurse who specializes in diabetes will teach these sessions. The sessions will have small groups of five patients and it will last of one hour each day. The outline of the session is as follow (Figure 1): First session: Insulin administration and blood glucose self-analysis Second session: Management of hypoglycemia and hyperglycemia Third session: Healthy diet adapted to the diabetic patient Four session: Physical exercise
Usual care
EXPERIMENTALParticipants in control group receive usual services offered in University Hospital and other local health systems for patients with diabetes, which include regular visits with a diabetes provider (primary care or endocrine) and standard Spanish Diabetes Society information pamphlets. Consultation care is centralized in the pharmacological treatment regimen, dosage and guidelines.
Interventions
Participants randomized to this arm receive therapeutic education during four sessions of four consecutive days. An advanced practice nurse who specializes in diabetes will teach these sessions. The sessions will have small groups of five patients and it will last of one hour each day. The outline of the session is as follow (Figure 1): First session: Insulin administration and blood glucose self-analysis Second session: Management of hypoglycemia and hyperglycemia Third session: Healthy diet adapted to the diabetic patient Four session: Physical exercise
Eligibility Criteria
You may qualify if:
- Have a confirmed diagnosis of type 1 diabetes
- years old and above
- Able to speak, read and listen Spanish
You may not qualify if:
- Have suffered from severe complications such as severe stroke, visual impairment or renal failure that interfere from severe complications such as severe stroke, visual impairment or renal failure that interfere with self-care activities
- Have a history of major psychiatric conditions (for example schizophrenia), other than depression or anxiety
- Have reading and hearing diffuculties
- Be in police custody
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Romero-Castillo R, Pabon-Carrasco M, Kaknani-Uttumchandani S, Ponce-Blandon JA. Effects of Continuous Glucose Monitoring on Glycemic Control, Mental Health and Self-Management in Adults with Type 1 Diabetes: A Randomized Controlled Trial. Healthcare (Basel). 2025 Dec 5;13(24):3197. doi: 10.3390/healthcare13243197.
PMID: 41464266DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- To achieve a well balance in the randomization procedure block randomization of size 10 (with five experimental and five control) in seal envelops will be used. It will use the computerized randomization programme to generate the randomization programme to generate the randomization list using with block size of 10. A team member who will not be involved in recruitment and data collection will prepare the sealed envelopes according to the generated randomization list. After a patient is registered, a unique patient ID will be assigned to the patient based on the sequence of his/her enrolment. The envelope according to the patient's ID will be opened on site and the patient will be allocated into either one of the two groups based on the randomization list the treatment indicated. Both patient and nurses offering therapeutic education will be blinded in this study and they will not know the objectives of the investigation.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 22, 2021
First Posted
December 16, 2021
Study Start
January 10, 2022
Primary Completion
May 31, 2022
Study Completion
September 1, 2022
Last Updated
December 16, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share
According to the ethics committee and to respect data protection, clinical data will not be uploaded. If others researchers wants more information, they will contact the IP (Rocío Romero Castillo)