N/A
Completed N=499
A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes
Source: ClinicalTrials.gov NCT00674986 ↗Enrolled (actual)
499
Serious AEs
7.2%
Results posted
Oct 2013
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 — -0.88; -1.16 Percent — p=0.0416
Summary
This randomized, parallel group study will determine whether the use of episodic, intensive glucose monitoring via the Accu-Chek 360 view blood glucose analysis system has a positive effect on overall glycemic control. Patients will be randomized into either the 'usual care' group, or the 'interventional group' supplemented with the Accu-Chek 360 view blood glucose analysis system. The effect of each treatment regimen on glycemic control will be assessed by measurement of change in baseline HbA1c values at 12 months. The anticipated time on study treatment is 1 year, and the target sample size is 504 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 |
-0.88; -1.16 | 0.0416 sig |
| SECONDARY Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations |
1.1; 2.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Depression Severity (PHQ-8) |
-1.1; -1.7 | 0.2777 |
| SECONDARY Change From Baseline in the Diabetes Distress Scale (DDS) |
-0.40; -0.55 | 0.1160 |
| SECONDARY Change From Baseline in the World Health Organization (WHO-5) Well-being Index |
4.1; 7.4 | 0.1146 |
| SECONDARY Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2) |
2.7; 5.8 | 0.0470 sig |
| SECONDARY Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day |
1.15; 0.89 | 0.0003 sig |
| SECONDARY Glycemic Variability Pre and Post-Prandial Excursions at Each Meal |
44.0; 34.7; 25.0; 17.3; 33.6; 25.8 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients >= 25 years of age
- Type 2 diabetes for >= 1 year
- Hemoglobin A1c >= 7.5% and <=11%
- Diabetes managed by exercise and diet, prescription oral medication or an injectable incretin mimetic
Exclusion Criteria
- Type 1 diabetes
- On any type of insulin therapy at start of study
Data sourced from ClinicalTrials.gov (NCT00674986). 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.