A Phase 4 interventional study of Insulin pump and Insulin injections in Type 1 Diabetes Mellitus, sponsored by University of Campania Luigi Vanvitelli. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2018-03-15.
Sponsored by University of Campania Luigi Vanvitelli · Phase 4, Interventional, and Treatment
Among 51 studies testing insulin in Diabetes Mellitus, Type 1 — 4 open to participants now, 4 under way, none of them phase 3. Insulin · Diabetes Mellitus, Type 1.
Among the 51 studies testing insulin in Diabetes Mellitus, Type 1, this one is the 7th largest by planned enrollment, is one of 6 that started in 2016, is one of 10 in phase 4, and was the 40th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 150 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →4 of the 51 studies testing insulin in Diabetes Mellitus, Type 1 are open now, in 3 countries. Each count lists the studies.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 30 Years · all sexes · no healthy volunteers.
The full table on the hub →51 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 6 started in 2016.
Median enrollment 20 across the 51 interventional studies. Of the 41 that completed or were terminated, 15 (37%) have results posted.
12 of 51 have an industry lead sponsor. The 10 most frequent:
University of Campania Luigi Vanvitelli is the lead sponsor of 174 studies on the registry; 28 are open to participants now.
University of Campania Luigi Vanvitelli has 5 studies filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
3 of the studies testing insulin in Diabetes Mellitus, Type 1 that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03463564University of Campania Luigi VanvitelliInsulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients | 2026-12 |
| NCT06699810Emory UniversityModeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity | 2027-01 |
| NCT07293715Ohio State UniversityPermissive Versus Strict Intrapartum Glucose Management in Type 1 and Type 2 Diabetes (PRISM) | 2027-06 |
Among the 51 studies testing insulin in Diabetes Mellitus, Type 1, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Insulin Pump with rapid acting insulin analog lispro
Device: Insulin pump
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
Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.
Also known as: CSII
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
HbA1c change
Within and between groups difference in HbA1c levels
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: Baseline, 6 months, 12 months, 24 months
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)
Time frame: Through study completion, an average of 1 year
Change in weight
Time frame: Baseline, 12 months, 24 months
Change in lipid profile
Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
Time frame: Baseline, 12 months, 24 months
Total daily insulin doses/Kg
Time frame: 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).
Time frame: Baseline, 12 months, 24 months
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jan 2016, a primary completion of Dec 2026 and a completion of Dec 2026. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Insulin
University of Campania Luigi Vanvitelli →