N/A
Completed N=61
Mobile Insulin Titration Intervention
Source: ClinicalTrials.gov NCT01879579 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose — 88; 37 percentage of participants — p=<0.0001
Summary
The purpose of this pilot study is to determine whether text message (and phone) communication can be effectively utilized to adjust long-acting insulin, compared to standard practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose |
88; 37 | <0.0001 sig |
| SECONDARY Time to Reach Optimal Long-acting Insulin Dose |
3.00; 7.07 | 0.007 sig |
| SECONDARY Hemoglobin A1c |
-1.90; -1.81 | 0.99 |
| SECONDARY Baseline Treatment Satisfaction |
4.99; 5.20 | 0.78 |
| SECONDARY Treatment Satisfaction After Initiation of Insulin Titration |
5.74; 5.53 | 0.04 sig |
| SECONDARY Change in Treatment Satisfaction |
2.71; 2.42 | 0.13 |
| SECONDARY Incidence of Hypoglycemia |
5; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Initiating long-acting insulin treatment or initiating the titration of long-acting insulin treatment
- Speaks English or Spanish
- Hemoglobin A1c > or = 8%
- Able and willing to inject insulin
- Able and willing to provide informed consent
Exclusion Criteria
- Short-acting insulin treatment
- Systemic glucocorticoids
- Sustained elevated serum creatinine > or = 1.5 mg/dL for men and > or = 1.4 mg/dL for women
- Hypoglycemia unawareness
- Type 1 diabetes
Data sourced from ClinicalTrials.gov (NCT01879579). 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.