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Behavioural Intervention

intervention group for Type 1 Diabetes

Phase < 1
Recruiting
Led By Jacob Kohlenberg, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability of the dyad (participant and Follower) to communicate and provide consent in English
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial aims to reduce severe high blood sugar in adults with type 1 diabetes who are at high risk for diabetic ketoacidosis (DKA). The study will involve using continuous glucose monitoring devices to

Who is the study for?
Adults aged 18-65 with Type 1 Diabetes Mellitus (T1DM), having an HbA1C level between 8.0% and 14.0%, who use a continuous glucose monitor (CGM) that can share data in real-time are eligible for this trial. They must also have a Follower willing to participate, and both should be able to communicate in English without cognitive impairments.Check my eligibility
What is being tested?
The study is testing the 'FAM intervention' which includes sharing glucose data with a designated Follower, creating an Action Plan, and Remote Monitoring of glucose levels to prevent severe hyperglycemia compared to standard diabetes care alone.See study design
What are the potential side effects?
Since the intervention involves monitoring and education rather than medication or medical procedures, there may not be direct side effects; however, stress or anxiety related to constant health tracking could potentially occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Both my partner and I can speak and understand English well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
percentage of time with severe hyperglycemia

Side effects data

From 2016 Phase 4 trial • 110 Patients • NCT02182115
2%
non-healing wound
2%
radial nerve palsy
2%
bacteremia
2%
Pneumonia
2%
pulmonary embolus
2%
DVT
2%
UTI
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Antiseptic Bundle

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: intervention groupExperimental Treatment1 Intervention
anticipate 20 CGM and 5 non-CGM user dyads in the intervention group
Group II: control groupActive Control1 Intervention
anticipate 20 CGM and 5 non-CGM user dyads in the control group

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,675 Total Patients Enrolled
Jacob Kohlenberg, MDPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical study include individuals who are aged 55 years or older?

"To be eligible for this research study, participants must fall within the age range of 18 to 65 years old."

Answered by AI

What is the upper limit on the number of participants who can be enrolled in this medical study?

"Indeed, information available on clinicaltrials.gov reveals that this particular clinical trial is actively seeking candidates. The study was initially posted on January 16th, 2024 and the latest update was made on February 9th, 2024. Recruitment aims to enroll a total of 100 participants from one designated site."

Answered by AI

Is the ongoing medical study actively seeking participants at this time?

"Indeed, the details on clinicaltrials.gov affirm that this research endeavor is actively seeking candidates. The trial was initially listed on January 16th, 2024, and its latest revision took place on February 9th, 2024. One hundred participants are sought from a solitary location."

Answered by AI

Do I meet the criteria to participate in this medical study?

"Inclusion Criteria:"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis
2024. "FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06114186.
~67 spots leftby Dec 2025
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