Type 1 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICETTSX2
Treatment with Tandem T Slim X2 with Basal IQ
DEVICEMM640G
Treatment with Medtronic Minimed 640G with Smartguard
Sponsors
Castilla-La Mancha Health Service
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes * Treated with TTSX2 or MM640.
Exclusion criteria
* Other kind of diabetes. * Serious mental disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TIR | during the procedure | time in range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TBR | during the procedure | time below range (TBR, \<70 mg/dL, \<3.9 mmol/L) of the interstitial glucose |
| TAR | during the procedure | time above range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose |
| HbA1C | during the procedure | Glycate haemoglobina A1C |
| GMI | during the procedure | Glucose management index |
| DQOL | during the procedure | Diabetes quality of life (EsDQOL questionnary score), 43 questions, each question with a score from 1 to 5, worse score is five points. |
| %CV | 14 days | Coefficient of variation percentage of the intersticial glucose |
| Hypoglycemia perception 1 | during the procedure | Hypoglycemia unawareness (Clarke questionnary score), 8 questions, each one score R or not R, more R means worse score. |
| Hypoglycemia perception 2 | during the procedure | Hypoglycemia unawareness (Gold questionnary scores), single question, score from 0 to 5, worse score is five points. |
| MAGE | during the procedure | Mean amplitude glucose excursions |
Countries
Spain
Outcome results
None listed