Type 1 Diabetes Clinical Trial
— STAR2Official title:
Pilot Study To Identify Effective Methods Of Training Pump Naïve Subjects To Use The Paradigm® 722 System And To Describe Clinical Effectiveness Compared To Subjects Continuing With Multiple Dose Injections (MDI) of Insulin
Verified date | May 2011 |
Source | Medtronic Diabetes |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Feasibility study to compare the effectiveness of the Paradigm Sensor Augmented System versus subjects continuing to administer insulin in multiple dose injections. Evaluate the educational materials and time required for training subjects naïve to continuous subcutaneous insulin infusion (CSII) to use the Paradigm 722 REAL Time System in preparation for a large multi-center clinical trial
Status | Completed |
Enrollment | 29 |
Est. completion date | September 2006 |
Est. primary completion date | September 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Subject is between 18 - 70 years of age (inclusive) - Subject is diagnosed with Type 1 Diabetes Mellitus as determined by the Investigator. - Diabetes is diagnosed > (greater or equal to) six (6) months prior to study entry. - A1C > 7.5% (greater than or equal to) as measured by the Central Laboratory at Screening Visit 1. - Subject currently requires insulin administration by injection > (greater or equal to) three (3) times daily. - Subject is currently (over past 3 months) performing an average of four (4) blood glucose measurements per day, as determined and documented by the investigator - Subject has been treated in the investigator's practice or in a referring endocrinologist's practice for at least 6 months prior to the study - Subject is fluent in speaking, understanding, and reading English. - Subject is able and willing to perform the study procedures and agrees to wear sensors at least five (5) days per week (722 Arm only) during the study period. - Subject is able to use the study devices (722 Arm only) as labeled - Subject has reviewed and signed the Informed consent, HIPPA Authorization, and California Experimental Subject's Bill of Rights (California only). - Subject has the capability to upload their insulin pumps or glucose meters every two weeks; access to the Internet and specific computer system requirements are necessary to participate in the study Exclusion Criteria: - Subject is pregnant or planning to become pregnant during the course of the study. - Subject has a history of tape allergies that have not been resolved. - Subject self-reports any skin abnormality (i.e. psoriasis, rash, and staphylococcus infection). - Subject has any additional condition(s) (medical, social, or psychosocial) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing or complying with the study requirements. - Subject is currently or within past 4 weeks participated in an investigational study (drug or device). Subject has a history of tape allergies that have not been resolved. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Diabetes Treatment Center, Loma Linda University | Loma Linda | California |
United States | Portland Diabetes & Endocrinology | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Medtronic Diabetes |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in A1C From Baseline to Week 15 | Change in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects. | Baseline and 15 weeks | No |
Secondary | Incidence of Severe Hypoglycemia Events Baseline to Week 15 | The total number of severe hypoglycemia events, defined as episodes requiring assistance from another person (i.e., subject is unable to treat self and requires carbohydrate or glucagon or other resuscitative actions) compared between the two study arms from Baseline to Week 15. | Baseline and 15 weeks | Yes |
Secondary | Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15 | Questionnaire measuring overall satisfaction with the relevant blood glucose monitoring system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response. | Baseline and 15 weeks | No |
Secondary | Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15 | Questionnaire measuring overall satisfaction with the relevant insulin delivery system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response. | Baseline and 15 weeks | No |
Secondary | Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15 | Questionnaire evaluating change in the subjects' fear of potential hypoglycemia events assessed Week 15 and compared between arms. Likert scale of 0 - 4 used with responses graded as the lowest number being the most acceptable and highest number the least acceptable. The questionnaire has two sections, Behavior and Worry with a maximum possible score of 60 for Behavior (15 X 4) and 72 for Worry (18 X 4). The total combined scoring of these two sections was then assessed at Baseline and Week 15 and the change from Baseline to Week 15 for each arm reported as the end of study result. | Baseline and 15 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT02750527 -
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
|