Diabetes Mellitus, Type 1
Conditions
Brief 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.
Interventions
DEVICECGM+CSII
Animas Vibe Platinum insulin pump and Dexcom G4 CGM
DEVICEMDI with degludec
Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Exclusion criteria
* HbA1c\>64 mmol/mol * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 4 months | Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe Hypoglycemia | 4 months | Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase |
| Local Reactions | 4 months | Number of participants with local reactions at infusion/glucose monitoring site |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CSII+CGM CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM | 14 |
| MDI With Degludec MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | CSII+CGM | MDI With Degludec | Total |
|---|---|---|---|
| Age, Continuous | 44 years | 41 years | 42 years |
| HbA1c | 61 mmol/mol STANDARD_DEVIATION 4 | 62 mmol/mol STANDARD_DEVIATION 5 | 61 mmol/mol STANDARD_DEVIATION 5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 8 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
HbA1c
Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII+CGM | HbA1c | -6.1 mmol/mol | Standard Deviation 4 |
| MDI With Degludec | HbA1c | 0.5 mmol/mol | Standard Deviation 4.5 |
Secondary
Local Reactions
Number of participants with local reactions at infusion/glucose monitoring site
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CSII+CGM | Local Reactions | 8 Participants |
| MDI With Degludec | Local Reactions | 0 Participants |
Secondary
Severe Hypoglycemia
Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CSII+CGM | Severe Hypoglycemia | 0 Participants |
| MDI With Degludec | Severe Hypoglycemia | 0 Participants |