Type1diabetesFREENCT03165786
A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes
A study testing FREE in people with Type1diabetes, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This study is being conducted to determine the feasibility of a cognitive behavioral therapy intervention to reduce fear of hypoglycemia and improve glucose levels in young adults with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- FREE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2016to 16 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- type 1 diabetes ≥ 1 year
- receive medical care from an endocrinologist
- use insulin pump therapy
- have self-reported fear of hypoglycemia (FOH;screening questionnaire)
Who cannot join
- pregnant or breastfeeding
- actively treated for a mental health condition
- have a co-existing chronic illness or taking medications (excluding insulin) that may influence diabetes self-management or glycemic variability
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
This study is being conducted to determine the feasibility of a cognitive behavioral therapy intervention to reduce fear of hypoglycemia and improve glucose levels in young adults with type 1 diabetes.
Read the detailed description
In persons with type 1 diabetes (T1DM), iatrogenic hypoglycemia is the major limiting factor in achieving optimal blood glucose control. All persons with T1DM are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and has serious physical symptoms and psychological sequelae that lead to profound fear of future hypoglycemic events. This fear results in greater glucose variability (the intra-day fluctuations in blood glucose), due to under- or overcompensation of food intake, insulin dosing, or physical activity, as well as anxiety, depression, and reduced quality of life. Greater glycemic variability (GV) is associated with a higher risk of hypoglycemia and diabetes complications. Young adults are particularly at risk because they report greater FOH and have poorer glycemic control. A major gap exists in how to manage FOH as a crucial component of diabetes self-care. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and variability in young adults with T1DM. We specifically aim to: (1) Determine the feasibility of an 8-week CBT-based intervention to reduce FOH and (2) obtain means and standard deviations of group differences from baseline to program completion on the outcomes of FOH, self-management, glycemic control and glycemic variability in young adults with T1DM who experience FOH. To achieve these aims, we propose a randomized control pilot trial in 10 young adults aged 18 to 30 years with T1DM. Participants will be screened for FOH levels. Eligible subjects will be randomized to the intervention (Fear Reduction Efficacy Evaluation [FREE]) program or attention control group. A 1-week run-in phase is planned, with baseline measures of FOH and 24-hour real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly one-hour sessions using a cognitive behavioral therapy (CBT) and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues. The control group will wear a 24-hour RT-CGM device during the same 8-week period and return for weekly RT-CGM site changes by study staff. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine within-group and between-group differences. The findings from this proposed study will serve as the foundation for a larger clinical trial to reduce FOH and improve self-management, glycemic control, and variability. Meeting these goals will have important clinical implications to reduce diabetes complications and improve quality of life in young adults with T1DM.
- Conditions
- Type1diabetes
- Being tested
- FREE
- Keywords
- fear of hypoglycemia, self-management, glycemic control, glycemic variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FREEBehavioural
Also called CBT
Cognitive behavioral therapy with real-time continuous glucose monitoring.
| Study group | Role | What they receive |
|---|---|---|
| FREE Group | Experimental | Cognitive behavioral therapy intervention with real-time continuous glucose monitoring. Receives: Behavioral: FREE |
| Control Group | No intervention | Real-time continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia Fear Scale Score (HFS_2)
A reliable and valid psychological scale. It is a 5-point Likert scale [0-4], that is summed for a single total continuous scale score. Scores may range from 0-72. Higher numbers indicate greater fear of hypoglycemia.
Measured: 12 weeks
Secondary outcomes (3)
Diabetes Self-Management Questionnaire Scale Score (DSMQ)
A reliable and valid behavioral scale, provides total continuous scale score, ranging from 0-81, higher numbers indicate better self-management.
Measured: 12 weeks
Glycemic Control, the Average Blood Glucose Over a 2-3 Month Period of Time.
Hemoglobin A1c represents the average blood glucose over a 2-3 month period and is an index of glycemic control. The American Diabetes Association recommends a hemoglobin A1C below 7% for most people with diabetes. Higher percentages indicate higher average blood glucose levels.
Measured: 12 weeks
Glycemic Variability
Twenty-four hour fluctuations in glucose measured by a continuous glucose monitor that provides interstitial glucose readings every 5 minutes. This is a continuous measure. A higher standard deviation reflects greater glycemic variability.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start26 Oct 2016
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Martyn-Nemeth, University of Illinois Chicago
- Investigators
- Pamela Martyn-Nemeth, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165786
- Sponsor's protocol ID
- 2016-0206
- Acronym
- FREE
- Status last verified
- Jan 2025
- First submitted
- 22 May 2017
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03165786
- Acronym / sponsor ID
- FREE / 2016-0206
- Conditions
- Type1diabetes
- Keywords
- fear of hypoglycemia, self-management, glycemic control, glycemic variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to determine the feasibility of a cognitive behavioral therapy intervention to reduce fear of hypoglycemia and improve glucose levels in young adults with type 1 diabetes.
Detailed description
In persons with type 1 diabetes (T1DM), iatrogenic hypoglycemia is the major limiting factor in achieving optimal blood glucose control. All persons with T1DM are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and has serious physical symptoms and psychological sequelae that lead to profound fear of future hypoglycemic events. This fear results in greater glucose variability (the intra-day fluctuations in blood glucose), due to under- or overcompensation of food intake, insulin dosing, or physical activity, as well as anxiety, depression, and reduced quality of life. Greater glycemic variability (GV) is associated with a higher risk of hypoglycemia and diabetes complications. Young adults are particularly at risk because they report greater FOH and have poorer glycemic control. A major gap exists in how to manage FOH as a crucial component of diabetes self-care. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and variability in young adults with T1DM. We specifically aim to: (1) Determine the feasibility of an 8-week CBT-based intervention to reduce FOH and (2) obtain means and standard deviations of group differences from baseline to program completion on the outcomes of FOH, self-management, glycemic control and glycemic variability in young adults with T1DM who experience FOH. To achieve these aims, we propose a randomized control pilot trial in 10 young adults aged 18 to 30 years with T1DM. Participants will be screened for FOH levels. Eligible subjects will be randomized to the intervention (Fear Reduction Efficacy Evaluation [FREE]) program or attention control group. A 1-week run-in phase is planned, with baseline measures of FOH and 24-hour real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly one-hour sessions using a cognitive behavioral therapy (CBT) and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues. The control group will wear a 24-hour RT-CGM device during the same 8-week period and return for weekly RT-CGM site changes by study staff. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine within-group and between-group differences. The findings from this proposed study will serve as the foundation for a larger clinical trial to reduce FOH and improve self-management, glycemic control, and variability. Meeting these goals will have important clinical implications to reduce diabetes complications and improve quality of life in young adults with T1DM.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| FREE Group | Experimental | Behavioral: FREECognitive behavioral therapy intervention with real-time continuous glucose monitoring. |
| Control Group | No intervention | –Real-time continuous glucose monitoring |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- type 1 diabetes ≥ 1 year
- receive medical care from an endocrinologist
- use insulin pump therapy
- have self-reported fear of hypoglycemia (FOH;screening questionnaire)
Key exclusion criteria (3 listed)
- pregnant or breastfeeding
- actively treated for a mental health condition
- have a co-existing chronic illness or taking medications (excluding insulin) that may influence diabetes self-management or glycemic variability
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 |
|---|---|---|
| FREEAlso: CBTCognitive behavioral therapy with real-time continuous glucose monitoring. | Behavioural | FREE Group |
Primary outcome
Hypoglycemia Fear Scale Score (HFS_2)
Time frame: 12 weeks
A reliable and valid psychological scale. It is a 5-point Likert scale [0-4], that is summed for a single total continuous scale score. Scores may range from 0-72. Higher numbers indicate greater fear of hypoglycemia.
3 secondary outcomes
Diabetes Self-Management Questionnaire Scale Score (DSMQ)
Time frame: 12 weeks
Glycemic Control, the Average Blood Glucose Over a 2-3 Month Period of Time.
Time frame: 12 weeks
Glycemic Variability
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Type1diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
RecruitingObservational study
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Type1diabetes
Active, not recruitingPhase 2
Reducing Innate Inflammation in New Onset Type 1 Diabetes
Type 1 Diabetes, type1diabetes
Recruiting
Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
Non-Nutritive Sweetener, Type 1 Diabetes
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.
Pamela Martyn-Nemeth, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FREE in people with Type1diabetes, run by University of Illinois Chicago 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 4 inclusion and 3 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 3 Feb 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hypoglycemia Fear Scale Score (HFS_2) (time frame: 12 weeks). 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 3 Feb 2025.