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The role of technology in obeying different types of treatment of insulin-dependent diabetes mellitus

The role of technology in self-management and adherence to different treatment regimens for insulin-dependent diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6qx7m5
Enrollment
Unknown
Registered
2019-04-22
Start date
2019-01-28
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus

Interventions

Seventy-five patients with insulin-dependent diabetes mellitus (type 1 or LADA) that are screened regularly for the Association of Diabetics of Ourinhos (ADO) were selected. Of these patients: 25 use
25 use simple multiple daily injections (MDI)
the other 25 patients use insulin in MDI under carbohydrate counts. All 75 patients will be submitted, at the initial and final moments of the study, to: collection of glycated hemoglobin (A1C) and ap
Device

Sponsors

Faculdade de Ciências Médicas da Santa Casa de São Paulo
Lead Sponsor
Associação dos Diabéticos de Ourinhos (ADO)
Collaborator

Eligibility

Age
0 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients under following at ADO with type 1 DM or LADA. Any age. Any A1C. Use of insulin analogues (ultra-slow - Detemir, Glargina 100, Glargina 300, Degludeca - and ultrafast - Glulisine, Aspart or Lispro). In the subgroup of patients under carbohydrate counts, those who have had this modality of treatment for at least 3 (three) months. In the subgroup of patients undergoing treatment with CSII, those who have had this treatment modality for at least 3 (three) months.

Exclusion criteria

Exclusion criteria: Patients with other types of DM than those previously mentioned. Patients who use insulin, but not in MDI scheme. Patients treated with conventional insulin (NPH - Neutral Protamine Hagedorn - and regular), although in an MDI scheme.

Design outcomes

Primary

MeasureTime frame
For this study, the improvement of adherence to treatment was equated with the optimization of glycemic control, which was objectively defined as the combined meeting of ALL the following criteria: Perform at least 4 (four) daily measures of capillary glycemia in more than 50% of the days of the weeks-focus. Report sports practice to the OneTouch Reveal® application, when done. For patients in the CSII group, perform temporary baselines when exercising. Reduced mean glycemia after meals between the initial and intermediate weeks (4 th and 8 th weeks of the study) or between the initial and final weeks of the study (weeks 4 and 12 of the study). Reduction of the total percentage of hyperglycaemia (capillary glycemia measurements greater than 180mg / dL or 10mmol / L) between the initial and intermediate focus weeks (4a and 8a weeks of the study) or between the initial and final focus weeks (4a and 12 weeks of study).

Secondary

MeasureTime frame
It was considered as secondary outcome of this study the combined encounter between: Absolute reduction between A1C start and end values. Increase in DSMP total score between your initial and final applications.

Countries

Brazil

Contacts

Public ContactFelipe de Oliveira

Associação dos Diabéticos de Ourinhos (ADO)

fmo.endocrinologia@gmail.com+55-014-30266498

Outcome results

None listed

Source: REBEC (via WHO ICTRP)