Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models. Together with wireless communication with blood glucose meter potentially facilitates achieving the target post prandial glucose levels. In this RCT authors assessed whether use of wireless communication between compatible devices: MiniMed insulin pump and blood glucose meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is the impact of exerting this tool on metabolic control in type 1 diabetic patients.
In this RCT 156 patients were randomly assigned to one of the 3 arms: group A- subjects using insulin pump bolus calculator wirelessly connected with blood glucose meter, group B- subjects using insulin pump bolus calculator without wireless communication with blood glucose meter or group C- insulin pump, without bolus calculator function. We compared the glycated hemoglobin levels and post- prandial hypoglycaemia after 3 months of observation between the groups. We also assessed secondary endpoints (mentioned above).
Patients were estimated at three time points: at the beginning, after 6 weeks and after 3 months of intervention. Investigators performed computer reports at each visit, with Medtronic CareLink Pro software.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSII+BC+CL | Experimental | Patients using insulin pump (CSII) bolus calculator (BC) wirelessly connected with blood glucose meter Contour Link (CL) |
|
| CSII+BC | Experimental | Patients using insulin pump (CSII) bolus calculator (BC) without wireless connection with blood glucose meter (CL) |
|
| CSII (insulin pump only) | No Intervention | Patients using insulin pump (CSII) without BC and connection with CL |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSII+BC+CL | Device | Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link) |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (Glycated hemoglobin) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post- prandial glycaemia | Post- prandial glycaemia is express as a mean post- prandial glycaemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days | 2 hours after the meals |
| Treatment satisfaction |
| Measure | Description | Time Frame |
|---|---|---|
| Total daily dose of insulin | Total daily dose of insulin express as jm/kg/d | 3 months |
| Body mass index- standard deviation (BMI- sds) | Body mass index- sds |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Agnieszka Szypowska, A. Professor | Medical University of Warsaw | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw | Warsaw | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24115314 | Derived | Ramotowska A, Szypowska A. Bolus calculator and wirelessly communicated blood glucose measurement effectively reduce hypoglycaemia in type 1 diabetic children - randomized controlled trial. Diabetes Metab Res Rev. 2014 Feb;30(2):146-53. doi: 10.1002/dmrr.2477. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CSII+BC | Device | Insulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link) |
|
|
Simple questions regarded treatment satisfaction and wish to continuation.
| 3 months |
| Hypoglycaemia episodes and severe hypoglycaemia events | Hypoglycaemia defined as glycaemia below 70 mg/dl and, separately, glycaemia below 50 mg/dl. | 3 months |
| Frequency of self- blood glucose monitoring | Number of self- blood glucose monitoring per day | 3 months |
| Hyperglycaemic episodes | Hyperglycaemia defined as glycaemia above 180 mg/dl | 3 months |
| Frequency of meal boluses | Number of meal boluses per day | 3 months |
| Frequency of bolus calculator using | Number of bolus calculator use per day | 3 months |
| 3 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |