Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients

NCT03463564 | Recruiting Phase 4

• 1 other identifier: 24012014-33
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The transition from the Pediatric clinic to the adult care is a challenging period for young adults with type 1 diabetes, due to the high risk of poor glycemic control. Achieving the glycemic target without hypoglycemia and/or large glucose excursions is of paramount importance for type 1 diabetic patients, who have high variability of daily glucose levels . Both insulin pump therapy and multiple daily injections of insulin are recommended strategy to achieve glycemic control in type 1 diabetes; however, no studies investigated the effects of insulin pump vs insulin injections on glycol-metabolic outcomes in the transition phase. The aim of this study was to evaluate the effects of continuous subcutaneous insulin infusion (CSII) therapy, as compared with multiple daily injections of insulin (MDI), on glycemic and metabolic control, in young type 1 diabetic patients transitioned to the adult diabetes care.

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes; transition; CSII; MDI; glycemic control; glucose variability

Outcome Measures

Primary Outcomes (5)

• HbA1c change

  Within and between groups difference in HbA1c levels

  Baseline, 6 months, 12 months, 24 months

• Change in mean amplitude glucose excursions (MAGE

  Within and between groups difference in glucose variability measured as mean amplitude of glucose excursions (MAGE).

  Baseline, 6 months, 12 months, 24 months

• Change in coefficient of variation (CV)

  Within and between groups difference in glucose variability measured as coefficient of variation (CV).

  Baseline, 6 months, 12 months, 24 months

• Change in standard deviation (SD) of mean glucose levels

  Within and between groups difference in glucose variability measured as standard deviation (SD) of mean glucose levels

  Baseline, 6 months, 12 months, 24 months

• Change in glucose variability

  Within and between groups difference in time in the euglycemic range, defined as the minutes per day spent in glucose levels ranging between 70-180 mg/dL

  Baseline, 6 months, 12 months, 24 months

Secondary Outcomes (5)

• Occurrence of hypoglycemic events

  Through study completion, an average of 1 year

• Change in weight

  Baseline, 12 months, 24 months

• Change in lipid profile

  Baseline, 12 months, 24 months

• Total daily insulin doses/Kg

  Baseline, 12 months, 24 months

• Diabetes treatment satisfaction

  Baseline, 12 months, 24 months

Study Arms (2)

Insulin pump

ACTIVE COMPARATOR

Insulin Pump with rapid acting insulin analog lispro

Device: Insulin pump

Insulin injections

ACTIVE COMPARATOR

Four injections of insulin daily consisting in three bolus of a rapid-acting analog lispro or aspart before breakfast, lunch and dinner and one injection at bed-time of basal insulin glargine or degludec

Drug: Insulin injections

Interventions

Insulin pump DEVICE

Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.

Also known as: CSII

Insulin pump

Insulin injections DRUG

Four injections of insulin daily consisting in three bolus of a rapid-acting analog lispro or aspart before breakfast, lunch and dinner and one injection of insulin glargine or degludec at bed-time of basal insulin

Also known as: MDI

Insulin injections

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• T1DM for at least 12 months
• persistent HbA1c levels ≥ 7.5% (58 mmol/mol) despite optimized education therapy,
• recurrent severe hypoglycemic episodes or high glucose variability
• willingness to wear the insulin pump

You may not qualify if:

• previous use of insulin pump
• pregnancy or planning to become pregnant in the next 2 years,
• lack of ability to use the study devices
• history of severe chronic diseases
• recent or concomitant use of corticosteroids
• drug or alcohol abuse
• psychiatric complaints that interfere with the correct use of the devices

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Unit of Diabetes

Naples, 80138, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Katherine Esposito

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Esposito

CONTACT

+390815665031; katherine.esposito@unicampania.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Endocrinology and Metabolism, Head of Diabetes Unit

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 13, 2018
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)