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
Observational cross-sectional multicenter study about effectiveness of two different sensor augmented-pumps with low glucose predictive function in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.
Cross-sectional multicenter analysis about clinical effectiveness of two different sensor-augmented pumps, Tandem T Slim X2 with Basal IQ (TTSX2) and Medtronic Minimed 640G with Smartguard (MM640G) in adult patients with type 1 Diabetes mellitus.
All clinical variables are gathered from three EMR softwares and two sensor-augmented pumps sotwares.
Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A Kruskal-Wallis or a Friedman test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A "P" value < 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAP with LGS | Type 1 diabetes adults patients treated with sensor-augmented insulin pump with low glucose predictive suspension function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTSX2 | Device | Treatment with Tandem T Slim X2 with Basal IQ |
| |
| Measure | Description | Time Frame |
|---|---|---|
| TIR | time in range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose | during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| TBR | time below range (TBR, <70 mg/dL, <3.9 mmol/L) of the interstitial glucose | during the procedure |
| TAR | time above range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Type 1 diabetes adult patients treated with sensor-augmented pump (TTSX2 or MM640G)
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuestra Señora de la Candelaria University Hospital | Santa Cruz de Tenerife | Santa Cruz De Tenerife | 38010 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34653567 | Derived | Moreno-Fernandez J, Beato-Vibora P, Olvera P, Garcia-Seco JA, Gallego-Gamero F, Herrera MT, Munoz-Rodriguez JR. Real-world outcomes of two different sensor-augmented insulin pumps with predictive low glucose suspend function in type 1 diabetes patients. Diabetes Res Clin Pract. 2021 Nov;181:109093. doi: 10.1016/j.diabres.2021.109093. Epub 2021 Oct 13. |
Not provided
Not provided
All clinical data if requested.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| MM640G |
| Device |
Treatment with Medtronic Minimed 640G with Smartguard |
|
| during the procedure |
| HbA1C | Glycate haemoglobina A1C | during the procedure |
| GMI | Glucose management index | during the procedure |
| MAGE | Mean amplitude glucose excursions | during the procedure |
| %CV | Coefficient of variation percentage of the intersticial glucose | 14 days |
| DQOL | Diabetes quality of life (EsDQOL questionnary score), 43 questions, each question with a score from 1 to 5, worse score is five points. | during the procedure |
| Hypoglycemia perception 1 | Hypoglycemia unawareness (Clarke questionnary score), 8 questions, each one score "R" or "not R", more "R" means worse score. | during the procedure |
| Hypoglycemia perception 2 | Hypoglycemia unawareness (Gold questionnary scores), single question, score from 0 to 5, worse score is five points. | during the procedure |
| Badajoz University Hospital |
| Badajoz |
| 06080 |
| Spain |
| Obispo Rafael Torija, St. | Ciudad Real | 13005 | Spain |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |