N/A
Completed N=28
Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03557892 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: HbA1c — -6.1; 0.5 mmol/mol
Summary
Several studies have shown that Continuous Subcutaneous Insulin Infusion together with Continuous Glucose Monitoring improves glycemic control in type 1 diabetes when compared to more traditional approaches; however, in available trials the basal insulin used in multi-injection therapy is typically glargine, which is associated with a higher hypoglycemic risk than degludec.
This study will assess the efficacy and safety of Continuous Subcutaneous Insulin infusion (CSII) combined with Continuous Glucose Monitoring (CGM), as compared to Multiple Daily Injections (MDI) of insulin analogues, using degludec as basal insulin, associated with traditional self-monitoring of capillary blood glucose (SMBG) in patients with type 1 diabetes. A crossover design was chosen in order to minimize study sample improving statistical power.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c |
-6.1; 0.5 | — |
| SECONDARY Severe Hypoglycemia |
0; 0 | — |
| SECONDARY Local Reactions |
8; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes
- Duration of diabetes > 2 years
- Current treatment with MDI, using insulin analogues as bolus and basal insulin
- HbA1c 64 mmol/mol
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT03557892). 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.