None listed
Conditions
Brief summary
There are no data in Romania (and not so many worldwide) explaining why some patients fail to achieve good glycemic control during insulin therapy. Hypothetically, such failure could be the fault of the healthcare professionals (e.g. insufficient advice) or of the patients (e.g. poor adherence, fear of hypoglycemia). Starting from these observations, we had intended to assess effectiveness of enhanced education delivered by trained diabetes educators / nurses on the improvement of diabetes management. This disease registry evaluated the efficacy of enhanced education of patients with T2DM at the time of starting on basal insulin regimen. We estimated that we would detect a significant difference in mean value of HbA1c in-between both arms (patients with enhanced or standard education) at the end of 6 months observation period but not less than 0.3%. between the groups.
Interventions
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,
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
Sponsors
sanofi Romania
Study design
Allocation
Randomised controlled trial
Primary purpose
Educational / counselling / training
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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
Outcome results
None listed