N/A
Completed N=77
Education Effectiveness for Type 1 Diabetes Mellitus on Insulin Pump Therapy
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02423993 ↗
Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: HbA1c — 7.3; 8.0; 7.5; 8.8 percentage
Summary
The purpose of this study is to assess the effectiveness of structured group education on glycemic control and Quality of Life (QoL) among users of continuous subcutaneous insulin infusions (CSII).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c |
7.3; 8.0; 7.5; 8.8 | — |
| SECONDARY Severe Hypoglycaemia Frequency |
0; 0; 0; 0 | — |
| SECONDARY Quality of Life (ADDQoL Questionnaire) |
-1.68; -1.08; -1.09; -2.59; -0.74; -1.08 | — |
| SECONDARY Nonsevere Hypoglycaemia Frequency |
0.13; 0.49; 0.43; 0.004 | — |
| SECONDARY Glycaemic Variability |
— | — |
| SECONDARY Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use) |
6.7; 7.1; 4.6; 3.6; 6.0; 5.4 | — |
| SECONDARY Quality of Life (SF36 Questionnaire) |
95; 85; 95; 95; 88; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes mellitus;
- Disease duration > 1 year;
- Patients informed consent, approving participation and completion of questionnaires.
Exclusion Criteria
- Severe late diabetic complications (diabetic foot syndrome, painful neuropathy, autonomic neuropathy, significant loss of vision, glomerular filtration rate < 30 ml/min/1.73 m2);
- Pregnancy;
- Severe concomitant diseases;
- Known psychic disorders and/or treatment with psychotropic medicines.
Data sourced from ClinicalTrials.gov (NCT02423993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.