The impact of a structured diabetes education program for improving glycemic control in adults with type 2 diabetes

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001273471
• Date of registration: 09/09/2016
• Prospective Registration: No
• Primary sponsor: sanofi Romania
• Public title: The impact of a structured diabetes education program for improving glycemic control in adults with type 2 diabetes
• Scientific title: The assessment of the impact of a structured diabetes education program on glycaemic control in adult type 2 diabetes patients at initiation of basal insulin analogue
• Date of first enrolment: 22/10/2014
• Target sample size: 750
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001273471.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial;

Countries of recruitment

Romania

Contacts

• Name: Dr Cornelia Bala

• Name: Dr Cornelia Bala

Key inclusion & exclusion criteria

Inclusion criteria: 1. adults diagnosed with T2 DM
2. patients treated with stable doses of oral antidiabetics drugs (OADs) ( the dose was not modified in the last 3 months)
3. the diabetes is inadequately controlled with OADs and at investigator decision the patient is initiated on basal insulin analogues
4. the determination of HbA1c value must be available at the moment of the initiation of basal insulin analogues (determined in the last month)
5. Informed Consent Form signed

Exclusion criteria: The patient
1.was pregnant or breast-feeding or intented to be pregnant during the study
2.was treated with any systemic corticosteroid
3.was already included in other studies
4.had any contraindication to insulin treatment
5.patients not able to comply with - visit schedule


Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Diabetes

type 2 diabetes mellitus;
type 2 diabetes mellitus

Intervention(s)

In enhanced educational group
- Curriculum Modules 1: information about the importance of glycaemic control, diabetes complications video, reinforce the need of life style changes, how insulin works, training about device, glucometers and self monitoring blood glucose (SMBG), hypoglycaemia and titration+ brochure - guideline for patients realized by Romanian Association od Education in Diabetes - 45 minutes, provided by a trained nurse, in the first week after first visit, in physician office, one-on-one discussion
- Curriculum Modules 2: a short interview with patients about his/her knowledge and changes that he/her has done in the past 3 months; reinforce the information which was not very well understood, check SMBG diary and insulin titration algorithm; education about insulin treatment complication and the possibility of intensification need (how to check postprandial glycaemia) - 45 minutes, provided by a trained nurse in the first week after visit 2, in physician office, one-on-one discussion

All enrolled patients have performed 3 medical visits( first - baseline, at initiation, second - after 3 months, third - after 6 months); the data has been collected by the Investigators in the Case Report Forms (CRFs) and, on visits 1 and 3, the patients filled-in “EQ5D” and “Diabetes Empowerment Scale (DES”) questionnaires.
Not specific strategies used to monitor adherence

Primary Outcome(s)

the changes of HbA1c from baseline to the end of study in both groups
with structured education and control group[6 months after first visit]

proportion of patients reaching individualized target of HbA1c (established a priori by the physician) in each group (with / without enhanced education)[6 months after the first visit]

Secondary Outcome(s)

the incidence of confirmed symptomatic (<70 mg/dl) hypoglycemic episodes at the end of study for both groups - in number of events - measured by SMBG[6 months after enrollment]

the incidence of confirmed symptomatic (<70 mg/dl) hypoglycemic episodes at the end of study for both groups - in number of patients that experienced at least one hypoglycemic events - measured by SMBG[6 months after enrollment]

the incidence of severe hypoglycemic episodes (required third assistance) at the end of study for both groups in number of events - from patients interview or documented if was necessary the hospitalization [6 months after enrollment]

the incidence of severe hypoglycemic episodes (that required third assistance) at the end of study for both groups - in number of patients that experienced at least one hypoglycemic events - from patients interview or documented if was necessary the hospitalization [6 months after enrollment]

Secondary ID(s)

Identifiers assigned by the sponsor: DIREGL07301

Source(s) of Monetary Support

Sanofi

Ethics review

Status: Approved
Approval date:
Contact:

Romanian National Ethic Committee