Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: TTSX2
* Device: MM640G


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes Treated with TTSX2 or MM640. Exclusion Criteria: Other kind of diabetes. Serious mental disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SAP with LGS<br>Type 1 diabetes adults patients treated with sensor-augmented insulin pump with low glucose predictive suspension function | Device: TTSX2<br>* Treatment with Tandem T Slim X2 with Basal IQ<br>Device: MM640G<br>* Treatment with Medtronic Minimed 640G with Smartguard<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |