Advertisement

Topics

Feasibility Study of the Solo™ Insulin Pump

2014-08-27 03:16:22 | BioPortfolio

Summary

The purpose of this study is to assess the safety and usability of the Solo™ insulin MicroPump in subjects with type 1 diabetes who are pump users.

Description

This is a multi center, one arm, open label and prospective study to assess the safety and usability of the Solo™ MicroPump Insulin Delivery System .

The study will include a 30 days treatment period with the Solo MicroPump with no special care required for maintaining glycemic control.

The study will consist of up to 5 visits and one follow up phone call one week after termination of the study.

Visit 1 includes eligibility, baseline evaluation and training in handling of the Solo™ System. If no additional practice is required patients will be enrolled. Visit 2 will commence and Solo pump will be filled with insulin. If additional practice is required subject will be sent home for an additional training period of a few days practice using saline and then return for visit 2.

Treatment visits will take place at 3, 14 and 30 days after the enrolment. Subjects will be asked to record blood glucose measurements, daily activities and carbohydrate consumptions between visits.

Seven days after termination of study treatment a telephone contact with the study subject will take place for the purpose of adverse event reporting and the completion of DTSQ questionnaire.

Measurements that will be used for assessing the safety of the device are glucose levels and any occurrence of AE's.

Subjects will complete DTSQ and Performance questionnaires before and at the end of the treatment period for usability evaluation.

Blood and urine tests will be taken at visit 1 and 5, vital signs and physical examination will be evaluated at all study visits.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Type 1 Diabetes

Intervention

Solo MicroPump

Location

Medical University Graz
Gratz
Austria
A - 8036

Status

Recruiting

Source

Medingo Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:22-0400

Clinical Trials [4197 Associated Clinical Trials listed on BioPortfolio]

Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System

This interventional device study aims to compare mainly standard Multiple Dose Injection (MDI) therapy vs. Accu-Chek® Solo Micropump System and investigates participant satisfaction. In a...

A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Cholecystectomy

To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive ...

Clinical Study of Solo Tympanostomy Tube Device (TTD)

This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)

Clinical Study of the Solo Tympanostomy Tube Device

The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric ...

Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer

The purpose of this study is: 1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer? ...

PubMed Articles [9324 Associated PubMed Articles listed on BioPortfolio]

Association of Gestational Diabetes and Type 2 Diabetes Exposure In Utero With the Development of Type 2 Diabetes in First Nations and Non-First Nations Offspring.

Type 2 diabetes is increasing worldwide, disproportionately affecting First Nations (FN) people. Identifying early-life determinants of type 2 diabetes is important to address the intergenerational bu...

The discovery of novel predictive biomarkers and early-stage pathophysiology for the transition from gestational diabetes to type 2 diabetes.

Gestational diabetes mellitus (GDM) affects up to 20% of pregnancies, and almost half of the women affected progress to type 2 diabetes later in life, making GDM the most significant risk factor for t...

Treatment of type 2 diabetes: future approaches.

Type 2 diabetes, which accounts for ~90% of all diabetes, is a heterogeneous and progressive disease with a variety of causative and potentiating factors. The hyperglycaemia of type 2 diabetes is ofte...

Reciprocal Dynamics of Solo-Living and Health among Older Adults in Contemporary China.

Solo-living has far-reaching implications for older adults' well-being. The causal impacts and the pathways of solo-living on health and wellbeing of older adults are still unclear. This study examine...

Increased formations of neutrophil extracellular traps are associated with gut leakage in the patients with type 1 diabetes but not type 2 diabetes.

The aims of this study were to investigate the association of formation of neutrophil extracellular traps (NETs) with gut leakage not only in type 1 diabetes (T1D) but also in type 2 diabetes (T2D).

Medical and Biotech [MESH] Definitions

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

A severe type of hyperlipidemia, sometimes familial, that it is characterized by the elevation of both plasma CHYLOMICRONS and TRIGLYCERIDES contained in VERY-LOW-DENSITY LIPOPROTEINS. Type V hyperlipoproteinemia is often associated with DIABETES MELLITUS and is not caused by reduced LIPOPROTEIN LIPASE activity as in HYPERLIPOPROTEINEMIA TYPE I .

Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).

A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.

More From BioPortfolio on "Feasibility Study of the Solo™ Insulin Pump"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Diabetes
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...

Urology
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...


Searches Linking to this Trial