FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis

March 2, 2026 updated by: University of Minnesota
Diabetic ketoacidosis (DKA) results in significant morbidity and healthcare utilization and is the main contributor to loss of life expectancy in people with diabetes mellitus type 1 (T1DM) <50 years old. This suggests the need to develop interventions to reduce DKA events. Innovative features of newer continuous glucose monitoring devices offer opportunities for novel strategies to reduce DKA. Designating a family member, friend, or caregiver as a Follower was associated with reduction in HbA1C, increased time in range, and improvement in quality of life metrics in people with T1DM. However, the previously published studies are limited as they were either retrospective, survey-based, or do not overlap with our proposed cohort involving adults ages 18-65 with T1DM (prior prospective studies involved either pregnant women with T1DM or adults ≥60 years of age with T1DM). This study is a randomized controlled trial pilot study to evaluate an intervention (FAM) using a Follower, Action Plan, and Remote Monitoring of glucose data to reduce severe hyperglycemia, a modifiable risk factor for DKA, in adults with T1DM at high risk for DKA. The intervention uses real-time glucose data sharing with a Follower (family member, friend, or caregiver) and personalized diabetes education provided to the dyad (person with T1DM and their chosen Follower). The overall hypothesis is that the FAM intervention will improve glycemia with the primary outcome studied in this preliminary pilot study being percentage of time spent with glucose ≥250 mg/dL.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • People with T1DM for ≥1 year ages 18 - 65
  • HbA1C ≥7.5.0% - 14.0%
  • If the person with T1DM uses a CGM, the CGM must have the capability of real-time data sharing including glycemic alerts with a Follower (including but not limited to Dexcom G6 or G7 or FreeStyle Libre 2 or 3, or Medtronic Guardian Sensor 3)
  • Follower (family member or friend ages 18 years and older) willing to participate in the study and "follow" glucose data and who was no self-reported cognitive impairment
  • Ability of the dyad (participant and Follower) to communicate and provide consent in English
  • CGM users: ≥50% personal CGM use and ≥50% Dexcom G6 Pro CGM use during the pre-intervention period (days -14 to -1)
  • Non CGM users: ≥50% Dexcom G6 Pro CGM use and average ≥2 BGM readings/day during the pre-intervention period (days -14 to -1)

Exclusion Criteria:

  • Prisoner
  • Active treatment with a sodium-glucose cotransporter-2 inhibitor or planning to start a sodium-glucose cotransporter-2 inhibitor in the next 6 months
  • Active malignancy with the exception of non-melanoma skin cancer
  • Hospice
  • Skin conditions that inhibit wearing a CGM sensor and known severe allergy to adhesives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: control group
anticipate 8 CGM and 2 non-CGM user dyads in the control group
Device: FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data
using remote monitoring and real-time glucose data sharing with a Follower.
Experimental: intervention group
anticipate 8 CGM and 2 non-CGM user dyads in the intervention group
Other: standard of care
self reported HbA1C or GMI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
percentage of time with severe hyperglycemia
Time Frame: 90 days
number of continuous glucose monitoring or blood glucose monitoring readings with glucose ≥250 mg/dL divided by the total number of readings
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics
Time Frame: 90 days
-Percentage of time glucose >180 mg/dL
90 days
Severe hyperglycemia >400 mg/dL - Continuous Glucose Monitor glucose monitor (CGM) metrics
Time Frame: 90 days
-Percentage of time glucose >400 mg/dL
90 days
Hypoglycemia - continuous glucose monitor
Time Frame: 90 days
-Percentage of time glucose< 70 mg/dL
90 days
Hemoglobin A1c
Time Frame: days 0 and 90
-HbA1c
days 0 and 90
Level 2 Hypoglycemia - Continuous Glucose Monitor
Time Frame: 90 days
-Percentage of time glucose < 54 mg/dL
90 days
Time in Range - Continuous Glucose Monitor
Time Frame: 90 days
-Percentage of time glucose is 70 - 180 mg/dL
90 days
Glycemic variability - Continuous Glucose Monitor
Time Frame: 90 days
-Glycemic variability
90 days
Glucose Management Indicator - Continuous Glucose Monitor
Time Frame: 90 days
-Glucose Management Indicator
90 days
Number of glucose reading/day - Blood Glucose Monitor
Time Frame: 90 days
-Number of glucose readings/day
90 days
Hyperglycemia - Blood Glucose Monitor
Time Frame: 90 days
-Percentage of time glucose <180 mg/dL
90 days
Severe Hyperglycemia > 400 mg/dL - Blood Glucose Monitor
Time Frame: 90 days
-Percentage of time glucose >400 mg/dL
90 days
Hypoglycemia - Blood Glucose Monitor
Time Frame: 90 days
-Percentage of time glucose< 70 mg/dL
90 days
Level 2 Hypoglycemia -Blood Glucose Monitor
Time Frame: 90 days
-Percentage of time glucose < 54 mg/dL
90 days
Time in Range - Blood Glucose Monitor
Time Frame: 90 days
-Percentage of time glucose is 70 - 180 mg/dL
90 days
Ketone assessment
Time Frame: 90 days
-Frequency and severity of ketonuria assessed using urine ketone test strips
90 days
Assessment of the intervention's efficacy and its burden on participants
Time Frame: 90 days
-Questionnaire
90 days
Hypoglycemic Confidence Scale
Time Frame: 90 days
  • Likert Scale
  • Minimum value: Not Confident At All
  • Maximum value: Very Confident
90 days
Diabetes Distress Scale for Adults with T1DM
Time Frame: 90 days
  • Likert Scale
  • Minimum value: A Very Serious Problem
  • Maximum value: Not a Problem
90 days
Diabetes Empowerment Scale
Time Frame: 90 days
  • Likert Scale
  • Minimum value: Strongly Disagree
  • Maximum value: Strongly Agree
90 days
36-Item Short-Form Health Survey
Time Frame: 90 days
-Questionnaire
90 days
Hypoglycemic Confidence Scale for Partners of Adults with T1DM
Time Frame: 90 days
  • Likert Scale
  • Minimum value: Not Confident At All
  • Maximum value: Very Confident
90 days
Diabetes Distress Scale for Partners of Adults with T1DM
Time Frame: 90 days
  • Likert Scale
  • Minimum value: A great deal
  • Maximum value: Not at all
90 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospitalization for DKA
Time Frame: 90 days
-The number of DKA-related hospitalizations for each participant will be recorded
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacob Kohlenberg, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MED-2023-32321

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings