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Completed

NCT Number: NCT04741685

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nuestra Señora de la Candelaria University Hospital, Santa Cruz de Tenerife, Santa Cruz De Tenerife, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetes
  • Treated with TTSX2 or MM640.

Exclusion criteria

  • Other kind of diabetes.
  • Serious mental disease.

Treatment and study plan

TTSX2

Device

Treatment with Tandem T Slim X2 with Basal IQ

MM640G

Device

Treatment with Medtronic Minimed 640G with Smartguard

Primary outcomes

  1. TIR

    Time frame: during the procedure

    time in range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose

Secondary outcomes

  1. TBR

    Time frame: during the procedure

    time below range (TBR, <70 mg/dL, <3.9 mmol/L) of the interstitial glucose

  2. TAR

    Time frame: during the procedure

    time above range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose

  3. HbA1C

    Time frame: during the procedure

    Glycate haemoglobina A1C

  4. GMI

    Time frame: during the procedure

    Glucose management index

  5. MAGE

    Time frame: during the procedure

    Mean amplitude glucose excursions

  6. %CV

    Time frame: 14 days

    Coefficient of variation percentage of the intersticial glucose

  7. DQOL

    Time frame: 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.

  8. Hypoglycemia perception 1

    Time frame: during the procedure

    Hypoglycemia unawareness (Clarke questionnary score), 8 questions, each one score "R" or "not R", more "R" means worse score.

  9. Hypoglycemia perception 2

    Time frame: during the procedure

    Hypoglycemia unawareness (Gold questionnary scores), single question, score from 0 to 5, worse score is five points.

Sponsors and collaborators

Lead sponsor

Castilla-La Mancha Health Service

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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