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Completed

NCT Number: NCT03557892

Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes

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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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetologia AOU Careggi

Florence, 50134, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes
  • Duration of diabetes > 2 years
  • Current treatment with MDI, using insulin analogues as bolus and basal insulin
  • HbA1c<64 mmol/mol

Exclusion criteria

  • HbA1c>64 mmol/mol
  • Pregnancy or lactation

Treatment and study plan

CGM+CSII

Device

Animas Vibe Platinum insulin pump and Dexcom G4 CGM

MDI with degludec

Device

Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin

Primary outcomes

  1. HbA1c

    Time frame: 4 months

    Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)

Secondary outcomes

  1. Severe Hypoglycemia

    Time frame: 4 months

    Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase

  2. Local Reactions

    Time frame: 4 months

    Number of participants with local reactions at infusion/glucose monitoring site

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Official study title

Continuous Subcutaneous Insulin Infusion Associated With Continuous Glucose Monitoring in Comparison With Subcutaneous Multi-injection Insulin Therapy Using Degludec as Basal Insulin: a Randomized Crossover Trial in Type 1 Diabetes

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 15, 2018
Registry last updated
Jul 26, 2022

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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