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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSII+CGM | Experimental |
| |
| MDI with degludec | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM+CSII | Device | Animas Vibe Platinum insulin pump and Dexcom G4 CGM |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severe Hypoglycemia | Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase | 4 months |
| Local Reactions | Number of participants with local reactions at infusion/glucose monitoring site |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetologia AOU Careggi | Florence | 50134 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Subcutaneous Insulin Infusion+Continuous Glucose Monitoring (CSII+CGM) | CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM |
| FG001 | Multiple Daily Injections Regimen (MDI) With Degludec | MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CSII+CGM | CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM |
| BG001 | MDI With Degludec | MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1c | Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase) | Posted | Mean | Standard Deviation | mmol/mol | 4 months |
|
|
4 months for each treatment arm
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CSII+CGM | CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local skin reactions | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ilaria Dicembrini | University of Florence Medical School and AOU Careggi | +393387861041 | Ilaria.dicembrini@unifi.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 21, 2016 | Jul 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D036501 | Metered Dose Inhalers |
| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| D004864 | Equipment and Supplies |
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| MDI with degludec |
| Device |
Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin |
|
| 4 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| HbA1c | Mean | Standard Deviation | mmol/mol |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Severe Hypoglycemia | Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | Local Reactions | Number of participants with local reactions at infusion/glucose monitoring site | Posted | Count of Participants | Participants | 4 months |
|
|
|
| 14 |
| 0 |
| 14 |
| 8 |
| 14 |
| EG001 | MDI With Degludec | MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin | 0 | 14 | 0 | 14 | 0 | 14 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |