Health TrialsbyHealthPanel

Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes

ConditionType 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInsulet Corporation

About this trial

A multi-center, 26-week randomized controlled trial (RCT) to evaluate the safety and efficacy of the fully closed loop Omnipod M System in adults with type 2 diabetes using basal/bolus insulin therapy or basal-only insulin therapy, with the primary endpoint after 15 weeks and secondary analysis at 26 weeks; followed by an extension phase after completion of the 26-week trial where the Intervention group will continue to use Omnipod M and the Control group will crossover to use Omnipod M for 26 weeks

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age at time of consent 18-75 years (inclusive)

Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening

On insulin therapy for at least 3 months at time of screening, with no change to insulin regimen for 6 weeks prior (AID use within past 3 months excluded) to initiating baseline CGM data collection.

Regimen is defined as (1) Basal-bolus insulin therapy (a) using multiple daily injections of insulin (MDI), (b) non-automated insulin pump, or (c) MDI with premix insulin; or (2) basal insulin only (without bolus insulin).

Disqualifiers

Use of an automated insulin delivery pump within 3 months prior to screening

Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse.

Current or known history of coronary artery disease that is not stable with medical management in the opinion of the investigator, including unstable angina, despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening

Any planned surgery during the study which could be considered major in the opinion of the Investigator

Trial design

Design model

Parallel

Treatments tested in this trial

  • Device: Omnipod M System with study CGM

    Device

    The Omnipod M system with the study CGM

  • Standard Therapy plus study CGM

    Device

    Standard therapy is continuation of pre-study insulin regimen and study CGM.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Intervention group - Omnipod MExperimental treatment 1 intervention
Group B: Control group - Pre-study insulin regimenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

Change in HbA1c (%) from baseline between the intervention and control groups

Time frame
15 and 26 weeks

Secondary outcomes

1

Mean glucose

Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups

Time frame
15 and 26 weeks
2

Time in Range 70-180 mg/dL

Change in CGM percent time 70-180 mg/dL from baseline, compared between the intervention and control groups

Time frame
15 and 26 weeks
3

Time > 180 mg/dL

Change in CGM percent time \>180 mg/dL from baseline, compared between the intervention and control groups

Time frame
15 and 26 weeks
4

Time > 250 mg/dL

Change in CGM percent time \>250 mg/dL from baseline, compared between the intervention and control groups

Time frame
15 and 26 weeks

Other outcomes

1

Total daily insulin (TDI) and TDI/kg

Change in TDI and TDI/kg from baseline, compared between the intervention and control groups

Time frame
15 and 26 weeks
2

Percentage of insulin delivered via autobolus

Change in percentage of insulin delivered via autobolus from baseline, compared between the intervention and control groups

Time frame
15 and 26 weeks
3

Weight and body mass index

Change in weight and body mass index from baseline, compared between the intervention and control groups

Time frame
15 and 26 weeks
4

Patient reported outcome surveys

Time frame
15 and 26 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insulet Corporation

Lead sponsor

Jaeb Center for Health Research

Collaborator

Source ClinicalTrials.gov
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