N/A
Completed N=151
The Effectiveness of Intervention on Insulin Injection
Source: ClinicalTrials.gov NCT03324451 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Change in Glycosylated Hemoglobin (HbA1c) Levels — -1.47; -2.00 percent of glycosylated Hb
Summary
The aim of the study is to assess the effectiveness of an intervention for insulin injection initiation based on the Transtheoretical Model (TTM) for insulin-naïve patients with type 2 diabetes mellitus (T2DM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Hemoglobin (HbA1c) Levels |
-1.47; -2.00 | — |
| SECONDARY Change in Diabetes Empowerment Process |
0.52; -2.13 | — |
| SECONDARY Change in Diabetes Distress |
-2.91; -3.63 | — |
| SECONDARY Change in Quality of Life |
2.6; 5.45 | — |
| SECONDARY Change in Body Mass Index |
1.06; 0.85 | — |
Eligibility Criteria
Inclusion Criteria
(1) diagnosed with T2DM for at least half a year; (2) aged 20-70 years old; (3) controlling diabetes only through oral medication, without previous experience in insulin injection; (4) HbA1c≧8.5% as measured more than twice in a year; (5) considered suitable and recommended by the doctor to initiate insulin injection.
Exclusion Criteria
(1) unable to communicate with language; (2) incapable of self-administering insulin injection due to visual or muscular impairment.
Data sourced from ClinicalTrials.gov (NCT03324451). 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.