We regularly have new studies that we are recruiting for. If you don’t see something that you qualify for right now, please call Caitlin at 952-993-9605 or complete the questionnaire at this link to be contacted about future studies.
A Single-arm Trial with an Innovative Automated Insulin Delivery System for Type 2 Diabetes (twiist-T2D)
Study sponsor: DEKA Research & Development Corp., Sequel Med Tech
Location: International Diabetes Center
Purpose of study: The purpose of this study is:
• To see how well the twiist® insulin pump system works for people with type 2 diabetes who use insulin.
• An insulin pump can be used instead of injections for some people who use insulin for their diabetes.
• This system consists of an insulin pump, a Libre 3 or 3+ glucose sensor, and a computer program (Tidepool algorithm). The system uses continuous glucose readings from the sensor information to tell the insulin pump how much insulin to infuse automatically to help control glucose levels in people who have type 2 diabetes.
Involvement in the trial will include:
• The twiist® insulin pump system is provided for use during the study, including related supplies, at no cost to you.
• Compensation for completed study visits
• Diabetes management and education, support and guidance by diabetes professionals
• Study-related medical care, including regular health checks and lab tests provided at no cost to you
Inclusion Criteria:
- The study is accepting individuals ages 18-80 who:
- Have had type 2 diabetes for 6 months or longer
- Take insulin injections or use an open-loop insulin pump
- Are willing to use Humalog or Novolog insulin throughout the study
Study Contact:
Caitlin Moening
(952) 993-9605
IDCResearch@parknicollet.com
CONtiNuous glucosE monitoring (CGM) in people wiTh type 2 diabetes not on insulin: The CONNECT Study
Study sponsor: Dexcom
Location: International Diabetes Center
Purpose of study: This research study is being done to better understand how using continuous glucose monitoring (CGM), along with your usual diabetes medications, works to improve blood sugars compared to your usual diabetes management. Each qualifying participant will have the opportunity to use a CGM.
The CGM is a small device worn on the upper arm that allows you to see what your blood sugar level is at any time of the day. The system has a sensor that measures blood sugar level continuously and the results can be seen on your smartphone.
Participants will receive the following, at no cost:
– Study-related medical care and lab tests
– Continuous glucose monitoring supplies
– Payment for completed visits
Inclusion Criteria
You may qualify if you:
– Are age 18 or older
– Have type 2 diabetes
– Do NOT take insulin
– Have an A1C of 7.5% or higher
– Have never used a CGM, or have not used one recently
– Meet other study specific requirements
Study Contact:
Caitlin Moening
(952) 993-9605
IDCResearch@ParkNicollet.com
Frequency of Ketosis in People Living with Diabetes or Other Medical Conditions
Study Sponsor: Abbott Diabetes Care
Location: International Diabetes Center
Purpose of study: The purpose of this research study is to use the investigational FreeStyle Libre X Continuous Glucose Monitoring System to collect both ketone and glucose levels, and to learn about how often elevated ketones occur in adults and children living with diabetes and other medical conditions which may affect these levels. Ketones are acids made by the body when using fats for energy instead of carbohydrates. Study participation includes 2-3 appointments over a period of about 3-6 weeks.
Participants will receive:
– The study system to use during participation
– Compensation for completed visits and use of study diary
– Study related lab tests at no cost
Inclusion criteria:
You may qualify if you:
– Have diabetes:
- type 1 (ages 2 and up)
- type 2 diabetes
- gestational diabetes OR are pregnant and have type 1 or type 2 diabetes
– AND/OR have heart failure
– Meet other study specific requirements
Study Contact:
Caitlin Moening
(952) 993-9605
IDCResearch@parknicollet.com
Luna Automated Insulin Delivery for Multiple Daily Injectors (AID4MDI)
Study Sponsor: Luna Health
Location: International Diabetes Center
Purpose of study: This study will be testing a new investigational insulin delivery system designed to be worn just at night by individuals with type 1 diabetes who take their insulin by injections. This is being done to see if the study system lowers blood sugars for those who may have high blood sugar during sleep and when they wake up. The Luna System works with a person’s continuous glucose monitor (CGM) to provide small amounts of rapid-acting insulin during sleep and does not replace other insulins you are taking. It is investigational, meaning it hasn’t yet been cleared by the FDA to be sold on the market. The study lasts about 17weeks
and involves putting the device on before bed for about 13 of those weeks.
What will participants receive?
– The Luna system is provided for use during the study, at no cost to you.
– Compensation will be provided for completed study visits and questionnaires
– Study-related medical care and lab tests are provided at no cost to you
– Diabetes management and education, support and guidance provided by diabetes professionals
Inclusion Criteria:
The study is accepting individuals ages 18 and older who:
– Have had type 1 diabetes for at least 6 months
– Use insulin injections for their diabetes
– Have been wearing a CGM for at least the last 3 months
– Are willing to use the study system at night throughout the study
– Meet other study specific requirements
Study Contact:
Caitlin Moening
(952) 993-9605
IDCResearch@parknicollet.com
MARITIME-2
Study sponsor: Amgen Inc.
Location: International Diabetes Center
Phase of Study: III
Purpose of study: This study is being done to see if a new medicine can lower weight and improve weight-related conditions in people with type 2 diabetes. All participants will continue taking their usual diabetes medications.
Participants will receive:
– Study medication provided at no cost
– Travel reimbursement for completed visits
– Study-related procedures at no cost
Inclusion Criteria
The study is accepting individuals ages 18 and older who:
– Have type 2 diabetes
– Are either taking oral medications or diet and exercise for their diabetes
– Have an A1C between 7-10%.
– Meet other study specific requirement
Study Contact:
Caitlin Moening
(952) 993-9605
IDCResearch@parknicollet.com
Observation and Identification of Glycemic Metrics and Patterns in People with and without Prediabetes (PREMAP)
Study Sponsor: Abbott Diabetes Care
Location: International Diabetes Center
Purpose of study: Help us better understand glucose patterns for those with or without prediabetes. The purpose of this research study is to observe and identify patterns in how a person’s glucose changes using the FreeStyle Libre 3 Continuous Glucose Monitoring (CGM) System. This study will include people with and without prediabetes. The study includes 2-3 appointments over a period of about 15-20 days. Information collected in this study could lead to new and potentially more effective methods to diagnose prediabetes and may help to better understand ways in which continuous glucose monitoring can be used for persons with prediabetes or glucose tolerance issues.
Participants will receive:
– The study system to use during participation
– Compensation for completed visits
– Study related lab tests at no cost
Inclusion Criteria:
You may qualify if you:
– Have been diagnosed with prediabetes. The study is also enrolling those who do not have prediabetes.
– Are not taking medications for diabetes or weight loss
– Are willing to wear a continuous glucose monitor
– Are willing to complete an oral glucose tolerance test
– Meet other study specific requirements
Exclusion Criteria:
– Individuals with a diagnosis of diabetes are not eligible.
Study Contact:
Caitlin Moening
(952) 993-9605
IDCResearch@parknicollet.com
Safety and Efficacy of the Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals with Type 1 Diabetes (STRIVE)
Study sponsor: Insulet
Location: International Diabetes Center
Purpose of study: Join us as we trial an updated version of the Omnipod 5 system! This new investigational version of the Omnipod 5 system, called Omnipod 5 Smart Adjust 2.0 (SA2.0), is equipped with a lower target (100 mg/dL) and an updated adaptive automated insulin algorithm. The new system is not yet FDA approved and is considered investigational. Participation in this study will include 4-5 office visits over 3-4 months. All participants will have the opportunity to spend part of the study using the updated system. The Omnipod 5 SA2.0 Algorithm adjusts insulin delivery based on several factors including a user-set glycemic target and the user’s Total Daily Insulin (TDI).
Participants will receive:
– The study system to use during participation
– Compensation for completed visits
– Study related lab tests at no cost
Inclusion Criteria:
Individuals who may qualify:
– Have type 1 Diabetes
– Are between the ages of 2-13
– Are currently using the Omnipod 5
– Meet other study specific requirements
Study Contact:
Caitlin Moening
(952) 993-9605
IDCResearch@parknicollet.com
