Type 1 DiabetesEarly Phase 1NCT06114186
FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis
A Early Phase 1 study testing FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data in people with Type 1 Diabetes, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2024to 11 Feb 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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.
- Conditions
- Type 1 Diabetes
- Being tested
- FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data, standard of care
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose dataDevice
using remote monitoring and real-time glucose data sharing with a Follower.
standard of careOther
self reported HbA1C or GMI
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | anticipate 8 CGM and 2 non-CGM user dyads in the control group Receives: Device: FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data |
| intervention group | Experimental | anticipate 8 CGM and 2 non-CGM user dyads in the intervention group Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of time with severe hyperglycemia
number of continuous glucose monitoring or blood glucose monitoring readings with glucose ≥250 mg/dL divided by the total number of readings
Measured: 90 days
Secondary outcomes (22)
Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics
-Percentage of time glucose >180 mg/dL
Measured: 90 days
Severe hyperglycemia >400 mg/dL - Continuous Glucose Monitor glucose monitor (CGM) metrics
-Percentage of time glucose >400 mg/dL
Measured: 90 days
Hypoglycemia - continuous glucose monitor
-Percentage of time glucose< 70 mg/dL
Measured: 90 days
Hemoglobin A1c
-HbA1c
Measured: days 0 and 90
Level 2 Hypoglycemia - Continuous Glucose Monitor
-Percentage of time glucose < 54 mg/dL
Measured: 90 days
Time in Range - Continuous Glucose Monitor
-Percentage of time glucose is 70 - 180 mg/dL
Measured: 90 days
Glycemic variability - Continuous Glucose Monitor
-Glycemic variability
Measured: 90 days
Glucose Management Indicator - Continuous Glucose Monitor
-Glucose Management Indicator
Measured: 90 days
Number of glucose reading/day - Blood Glucose Monitor
-Number of glucose readings/day
Measured: 90 days
Hyperglycemia - Blood Glucose Monitor
-Percentage of time glucose <180 mg/dL
Measured: 90 days
Severe Hyperglycemia > 400 mg/dL - Blood Glucose Monitor
-Percentage of time glucose >400 mg/dL
Measured: 90 days
Hypoglycemia - Blood Glucose Monitor
-Percentage of time glucose< 70 mg/dL
Measured: 90 days
Level 2 Hypoglycemia -Blood Glucose Monitor
-Percentage of time glucose < 54 mg/dL
Measured: 90 days
Time in Range - Blood Glucose Monitor
-Percentage of time glucose is 70 - 180 mg/dL
Measured: 90 days
Ketone assessment
-Frequency and severity of ketonuria assessed using urine ketone test strips
Measured: 90 days
Assessment of the intervention's efficacy and its burden on participants
-Questionnaire
Measured: 90 days
Hypoglycemic Confidence Scale
- Likert Scale
- Minimum value: Not Confident At All
- Maximum value: Very Confident
Measured: 90 days
Diabetes Distress Scale for Adults with T1DM
- Likert Scale
- Minimum value: A Very Serious Problem
- Maximum value: Not a Problem
Measured: 90 days
Diabetes Empowerment Scale
- Likert Scale
- Minimum value: Strongly Disagree
- Maximum value: Strongly Agree
Measured: 90 days
36-Item Short-Form Health Survey
-Questionnaire
Measured: 90 days
Hypoglycemic Confidence Scale for Partners of Adults with T1DM
- Likert Scale
- Minimum value: Not Confident At All
- Maximum value: Very Confident
Measured: 90 days
Diabetes Distress Scale for Partners of Adults with T1DM
- Likert Scale
- Minimum value: A great deal
- Maximum value: Not at all
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start28 Mar 2024
- Primary completion11 Feb 2026
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized 1:1 to the intervention or control groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Kohlenberg, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114186
- Sponsor's protocol ID
- MED-2023-32321
- Status last verified
- Mar 2026
- First submitted
- 16 Oct 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT06114186
- Acronym / sponsor ID
- MED-2023-32321
- Conditions
- Type 1 Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized 1:1 to the intervention or control groups
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Device: FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose dataanticipate 8 CGM and 2 non-CGM user dyads in the control group |
| intervention group | Experimental | Other: standard of careanticipate 8 CGM and 2 non-CGM user dyads in the intervention group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose datausing remote monitoring and real-time glucose data sharing with a Follower. | Device | control group |
| standard of careself reported HbA1C or GMI | Other | intervention group |
Primary outcome
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
22 secondary outcomes
Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics
Time frame: 90 days
Severe hyperglycemia >400 mg/dL - Continuous Glucose Monitor glucose monitor (CGM) metrics
Time frame: 90 days
Hypoglycemia - continuous glucose monitor
Time frame: 90 days
Hemoglobin A1c
Time frame: days 0 and 90
Level 2 Hypoglycemia - Continuous Glucose Monitor
Time frame: 90 days
Time in Range - Continuous Glucose Monitor
Time frame: 90 days
Glycemic variability - Continuous Glucose Monitor
Time frame: 90 days
Glucose Management Indicator - Continuous Glucose Monitor
Time frame: 90 days
Number of glucose reading/day - Blood Glucose Monitor
Time frame: 90 days
Hyperglycemia - Blood Glucose Monitor
Time frame: 90 days
Severe Hyperglycemia > 400 mg/dL - Blood Glucose Monitor
Time frame: 90 days
Hypoglycemia - Blood Glucose Monitor
Time frame: 90 days
Level 2 Hypoglycemia -Blood Glucose Monitor
Time frame: 90 days
Time in Range - Blood Glucose Monitor
Time frame: 90 days
Ketone assessment
Time frame: 90 days
Assessment of the intervention's efficacy and its burden on participants
Time frame: 90 days
Hypoglycemic Confidence Scale
Time frame: 90 days
Diabetes Distress Scale for Adults with T1DM
Time frame: 90 days
Diabetes Empowerment Scale
Time frame: 90 days
36-Item Short-Form Health Survey
Time frame: 90 days
Hypoglycemic Confidence Scale for Partners of Adults with T1DM
Time frame: 90 days
Diabetes Distress Scale for Partners of Adults with T1DM
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Kohlenberg, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data in people with Type 1 Diabetes, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of time with severe hyperglycemia (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.