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Trial record 69 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT03557892
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Edoardo Mannucci, Azienda Ospedaliero-Universitaria Careggi

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: CGM+CSII Device: MDI with degludec Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : November 2, 2019
Estimated Study Completion Date : November 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: CSII+CGM Device: CGM+CSII
Animas Vibe Platinum insulin pump and Dexcom G4 CGM

Active Comparator: MDI with degludec Device: MDI with degludec
Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 4 months ]
    Variation of HbA1c in each treatment phase


Secondary Outcome Measures :
  1. Severe hypoglycemia [ Time Frame: 4 months ]
    Incidence of severe hypoglycemia in each treatment phase

  2. Body weight [ Time Frame: 4 months ]
    Weight change in each treatment phase

  3. Local reactions [ Time Frame: 4 months ]
    Local reactions at infusion/glucose monitoring site

  4. World Health Organization Diabetes Treatment Satisfaction Questionnaire [ Time Frame: 4 months ]
    8-item questionnaire, each rated on a seven-point Likert scale; six (items 1 and 4-8) are summed to produce a measure of treatment satisfaction with scores ranging from 0 (very dissatisfied) to 36 (very satisfied). The remaining two items are treated individually. Item 2 measures perceived frequency of hyperglycemia on a scale ranging from 0 (none of the time) to 6 (most of the time), and item 3 measures perceived frequency of hypoglycemia on the same scale.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557892


Contacts
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Contact: Edoardo Mannucci, MD 0557946514 edoardo.mannucci@unifi.it

Locations
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Italy
Diabetologia AOU Careggi Recruiting
Firenze, Italy, 50134
Contact: Ilaria Dicembrini, MD    0557946512    idicembrini@gmail.com   
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi

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Responsible Party: Edoardo Mannucci, Director, Diabetology, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT03557892     History of Changes
Other Study ID Numbers: T1DM001
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs