Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults (NCT05923827) | Clinical Trial Compass
CompletedNot Applicable
Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults
Belgium, France189 participantsStarted 2023-09-11
Plain-language summary
This study is a randomized, controlled trial to evaluate the efficacy and safety of the Omnipod® 5 System with the FreeStyle Libre 2 continuous glucose monitor compared to Multiple Daily Injections (MDI) along with the FreeStyle Libre 2 continuous glucose monitor in children and adults with type 1 diabetes.
Who can participate
Age range4 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age at time of consent 4-70 years.
✓. Clinical diagnosis of type 1 diabetes for at least 1 year prior to screening. Diagnosis is based on investigator's clinical judgement.
✓. On MDI therapy (≥ 3 insulin injections per day and/or a basal/bolus regimen) for ≥ 3 months prior to screening. Have used insulin for at least 1 year prior to screening.
✓. Have used the FreeStyle Libre 2 Sensor for ≥ 3 months with a daily average number of scans ≥ 4 and with sensor readings \> 70% of time over the previous month prior to screening. Sensor usage is determined from the download summary report for 30 days preceding screening visit.
✓. Must be willing to use the FreeStyle Libre 2 Sensor for the duration of the study.
✓. HbA1c 7.5-11% (58-97mmol/mol) by point-of-care taken at screening visit
✓. Deemed appropriate for pump therapy per investigator's assessment with respect to previous history of severe hypoglycemic and hyperglycemic events, other comorbidities, and capability of operating study devices and adhering to the protocol.
✓. Willing to use and obtain U-100 insulin: either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)) as the primary insulin treatment while using the Omnipod 5 System.
Exclusion criteria
✕. Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk.
What they're measuring
1
Change in HbA1c (%)
Timeframe: Comparing intervention group with control group during the 13-week study phase
✕. History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
✕. History of diabetic ketoacidosis (DKA) in the past 6 months.
✕. Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1c.
✕. Using any form of pump therapy, including non-automated and automated insulin delivery (AID) systems, within 6 months prior to screening.
✕. Currently on systemic steroids or intends to receive systemic steroid treatment in the next 6 months, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed. If previously on oral steroids, last intake should be ≥14 days prior to screening visit.
✕. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement.
✕. Use of non-insulin anti-hyperglycemic medication other than metformin, in the 12 weeks prior to the baseline visit and during the 6-month study. Participants taking metformin should remain on a steady dose during study participation.