Type 1 Diabetes MellitusPhase 4METRONCT03463564
Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients
A Phase 4 study testing Insulin pump and Insulin injections in people with Type 1 Diabetes Mellitus, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin pump and Insulin injections
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Unit of Diabetes
Naples, 80138
Katherine Esposito, +390815665031, katherine.esposito@unicampania.it
Katherine Esposito
About this study
Official title: Effects of Insulin Pump Versus Multiple Daily Injections of Insulin on Glycemic and Metabolic Control in Type 1 Diabetic Patients Transitioned to the Adult Center: the Management and Technology for Transition Study (METRO)
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
- Being tested
- Insulin pump, Insulin injections
- Keywords
- type 1 diabetes, transition, CSII, MDI, glycemic control, glucose variability
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin pumpDevice
Also called CSII
Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.
Insulin injectionsDrug
Also called MDI
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
| Study group | Role | What they receive |
|---|---|---|
| Insulin pump | Active comparator | Insulin Pump with rapid acting insulin analog lispro Receives: 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 Receives: Drug: Insulin injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change
Within and between groups difference in HbA1c levels
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: Baseline, 6 months, 12 months, 24 months
Secondary outcomes (5)
Occurrence of hypoglycemic events
Number of events of mild hypoglycemia (glucose levels below 70 mg/dl), or severe hypoglycemia (below 54 mg/dl or each episode of low glucose levels requiring assistance)
Measured: Through study completion, an average of 1 year
Change in weight
Measured: Baseline, 12 months, 24 months
Change in lipid profile
Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
Measured: Baseline, 12 months, 24 months
Total daily insulin doses/Kg
Measured: Baseline, 12 months, 24 months
Diabetes treatment satisfaction
In order to measure satisfaction with diabetes treatment regimens, we used the self-reported Diabetes Treatment Satisfaction Questionnaire. This instrument aims to assess levels of satisfaction in subjects using different treatment strategies. The questionnaire consists of eight questions: six questions addresses general satisfaction with a score from 0 to 6 for each question (0 = worst), that has to be computed in a total score ranging from 0 (=worst) to 36 (=best); among the remaining two questions, which has to be computed separately as two subscales, one concerns the perception of hyperglycemic events and another the perception of hypoglycemic events, both with a score from 0 (none of the time) to 6 (most of the time).
Measured: Baseline, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study startJan 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Esposito, University of Campania Luigi Vanvitelli
- Investigators
- Katherine Esposito, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463564
- Sponsor's protocol ID
- 24012014-33
- Acronym
- METRO
- Status last verified
- Mar 2018
- First submitted
- 19 Feb 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Insulin Pump Versus Multiple Daily Injections of Insulin on Glycemic and Metabolic Control in Type 1 Diabetic Patients Transitioned to the Adult Center: the Management and Technology for Transition Study (METRO)
- ClinicalTrials.gov ID
- NCT03463564
- Acronym / sponsor ID
- METRO / 24012014-33
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes, transition, CSII, MDI, glycemic control, glucose variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin pump | Active comparator | Device: Insulin pumpInsulin Pump with rapid acting insulin analog lispro |
| Insulin injections | Active comparator | Drug: Insulin injectionsFour 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin pumpAlso: CSIIContinuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals. | Device | Insulin pump |
| Insulin injectionsAlso: MDIFour 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 | Drug | Insulin injections |
Primary outcome
HbA1c change
Time frame: Baseline, 6 months, 12 months, 24 months
Within and between groups difference in HbA1c levels
Change in mean amplitude glucose excursions (MAGE
Time frame: Baseline, 6 months, 12 months, 24 months
Within and between groups difference in glucose variability measured as mean amplitude of glucose excursions (MAGE).
Change in coefficient of variation (CV)
Time frame: Baseline, 6 months, 12 months, 24 months
Within and between groups difference in glucose variability measured as coefficient of variation (CV).
Change in standard deviation (SD) of mean glucose levels
Time frame: Baseline, 6 months, 12 months, 24 months
Within and between groups difference in glucose variability measured as standard deviation (SD) of mean glucose levels
Change in glucose variability
Time frame: Baseline, 6 months, 12 months, 24 months
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
5 secondary outcomes
Occurrence of hypoglycemic events
Time frame: Through study completion, an average of 1 year
Change in weight
Time frame: Baseline, 12 months, 24 months
Change in lipid profile
Time frame: Baseline, 12 months, 24 months
Total daily insulin doses/Kg
Time frame: Baseline, 12 months, 24 months
Diabetes treatment satisfaction
Time frame: Baseline, 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Esposito principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin pump and Insulin injections in people with Type 1 Diabetes Mellitus, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Esposito (+390815665031, katherine.esposito@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c change (time frame: Baseline, 6 months, 12 months, 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.