Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03557892|
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: CGM+CSII Device: MDI with degludec||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Continuous Subcutaneous Insulin Infusion Associated With Continuous Glucose Monitoring in Comparison With Subcutaneous Multi-injection Insulin Therapy Using Degludec as Basal Insulin: a Randomized Crossover Trial in Type 1 Diabetes|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||November 2, 2019|
|Estimated Study Completion Date :||November 2, 2019|
Animas Vibe Platinum insulin pump and Dexcom G4 CGM
|Active Comparator: MDI with degludec||
Device: MDI with degludec
Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
- HbA1c [ Time Frame: 4 months ]Variation of HbA1c in each treatment phase
- Severe hypoglycemia [ Time Frame: 4 months ]Incidence of severe hypoglycemia in each treatment phase
- Body weight [ Time Frame: 4 months ]Weight change in each treatment phase
- Local reactions [ Time Frame: 4 months ]Local reactions at infusion/glucose monitoring site
- World Health Organization Diabetes Treatment Satisfaction Questionnaire [ Time Frame: 4 months ]8-item questionnaire, each rated on a seven-point Likert scale; six (items 1 and 4-8) are summed to produce a measure of treatment satisfaction with scores ranging from 0 (very dissatisfied) to 36 (very satisfied). The remaining two items are treated individually. Item 2 measures perceived frequency of hyperglycemia on a scale ranging from 0 (none of the time) to 6 (most of the time), and item 3 measures perceived frequency of hypoglycemia on the same scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557892
|Contact: Edoardo Mannucci, MDfirstname.lastname@example.org|
|Diabetologia AOU Careggi||Recruiting|
|Firenze, Italy, 50134|
|Contact: Ilaria Dicembrini, MD 0557946512 email@example.com|