T1DMEarly Phase 1NCT03594565
The Use of Topical Nasal Steroids for Skin Reactions to Continuous Glucose Monitoring System, Among Children and Youth With Type 1 Diabetes Mellitus: Case Series
A Early Phase 1 study testing Fluticasone Propionate in people with T1DM and Hypersensitivity, run by Assaf-Harofeh Medical Center.
Trial summary
Background Type 1 diabetes mellitus is a chronic metabolic disorder that presents a significant set of challenges to the patient, their family and the physician. Near normoglycemia is associated with a reduced risk of microvascular and macrovascular complications in type 1 diabetes mellitus but is difficult to achieve… Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- T1DM, Hypersensitivity
- What is being tested?
- Fluticasone Propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jun 2018
- 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 1 year to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1-20 years
- Local skin reaction to CGMS indicating local or systemic management.
Who cannot join
- Patients who were offered nsFP but did not actually use it.
About this study
Background Type 1 diabetes mellitus is a chronic metabolic disorder that presents a significant set of challenges to the patient, their family and the physician. Near normoglycemia is associated with a reduced risk of microvascular and macrovascular complications in type 1 diabetes mellitus but is difficult to achieve despite considerable effort from patients and healthcare providers . Furthermore, episodes of hypoglycemia are frequent and may endanger life acutely. Subcutaneous glucose monitoring systems (CGMS), also called sensors that continuously measure interstitial fluid glucose levels have become available recently, and approved for use in children. CGMS has made it possible to assess the patterns and trends of blood glucose and the substantial variability in glucose excursions in the population of type 1 diabetes, and to prevent severe hypoglycemic episodes. The benefits of this technology are most apparent with near continuous wear of the sensors and is incorporated into the day to day management of the individual's diabetes . These devices provide patients with information regarding postprandial and overnight glucose profiles that are rarely, if ever, obtained with conventional self monitoring of blood glucose using home glucose meters .
Skin reactions CGM systems measure the glucose content of interstitial fluid , using an electrochemical enzymatic sensor, which is accessed by a needle sensor inserted subcutaneously. The CGMS is compromised of a disposable subcutaneous glucose-sensing catheter connected by a cable to a pager sized glucose monitor . Problems related associated to skin irritation and sensor adhesiveness in these young children presents challenges to daily use of the CGMS. In the study conducted by Englert et al, for the Diabetes Research in Children (Directnet) Study Group - three primary factors that contributed to reduced CGM use were identified: the limited body surface area in smaller children, ambient temperature and humidity, as well as the type and duration of physical activity. A study conducted in Israel, by our group, demonstrated only 30% consistant use of the system, partly due to skin reactions . In our cohort, thirty participants of the CGMS group (36.1 %) had signs of local reaction to the RT-CGMS insertion. Mild-to severe local redness was reported in 19 % of patients and hyperpigmentation in 17 %. Skin reactions were among the reasons for discontinuation of CGMS (2/51 participants, 3.9 %).
Read more
The use of Local Fluticasone for dermatological use Fluticasone propionate - the first carbothioate corticosteroid - has been classified as a potent anti-inflammatory drug for dermatological use. It is available as cream and ointment formulations for the acute and maintenance treatment of patients with dermatological disorders such as atopic dermatitis, psoriasis and vitiligo. This glucocorticoid is characterized by high lipophilicity, high glucocorticoid receptor binding and activation, and a rapid metabolic turnover in skin. Several clinical trials demonstrate a low potential for cutaneous and systemic side-effects . Even among paediatric patients with atopic dermatitis, fluticasone propionate proved to be safe and effective. These pharmacological and clinical properties are reflected by the high therapeutic index of this glucocorticoid. The same drug is also available as a nasal spray ,for cases of allergic rhinitis.
The use of fluticasone in spray, sprayed on the location of CGMS insertion, prior to insertion to prevent adverse skin reactions in patients with type 1 DM using CGMS devices has not been addressed in the literature.
Hypothesis :
Minimizing skin irritation may significantly improve duration of use and tolerability of CGM devices by young children, as well a in young adults. The Investigators assumed that the simple use of a spray, which will not decrease the adhesiveness of the sensor, may improve use .
Methods Children whose parents had difficulty with CGMS due to irritation, redness were offered to use Flixonase (FLUTICASONE PROPIONATE), with an approval form 29ג, indicating it is not approved for this specific diagnosis .
The investigators followed those patients for improvement and possible local side effects.
Study population Every patient, treated by the pediatric and adolescents diabetes mellitus interdisciplinary service , Assaf Haroffe Medical Center , who experienced local reaction at the site of CGMS was offered this medical option .
Charts were reviewed for response . total participants - 15
- Conditions
- T1DM, Hypersensitivity
- Being tested
- Fluticasone Propionate
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone PropionateDrug
Local Fluticasone Propionate use prior to continuous glucose monitoring system insertion
| Study group | Role | What they receive |
|---|---|---|
| Local steroids prior to CGMS insertion | Experimental | topical spraying of fluticasone propionate nasal spray (nsFP) on the skin area of CGMS placement prior to sensor insertion in a group of pediatric T1D patients who had mild to severe local skin reactions to CGMS adhesives.
Dosage: 2 puffs. Receives: Drug: Fluticasone Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in skin irritation before and after regular application of nsFP according to the modified Draize scale.
Erythema and edema were assessed for adhesive and sensor-insertion areas on a 4-point scale, with total score ≤3 defined as mild, 4-5 as moderate, and 6-8 as severe.
Measured: 2 years from patient first enrollment
Secondary outcomes (4)
Change in BMI SDS
Weight (kg), height (meters), age (years) and sex will be combined to report BMI SDS
Measured: 6 months after nsFP use
Change in height SDS 6 months after nsFP use
Height (meters), age (years) and sex will be combined to report height SDS
Measured: 6 months after nsFP use.
Change in mean glucose 6 months after nsFP use
Mean glucose measured as mg/dl
Measured: 6 months after nsFP use.
Change in glycated hemoglobin 6 months after nsFP use
Glycated hemoglobin measured with the DCCT (Diabetes Control and Complications Trial) units, presented as percentage
The new mmols/mol values are known as the IFCC (International Federation of Clinical Chemistry) units.
Measured: 6 months after nsFP use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study startMar 2016
- Primary completionJun 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T1DMStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594565
- Sponsor's protocol ID
- 0277-16-ASF
- Status last verified
- Aug 2019
- First submitted
- 17 Jun 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Topical Nasal Steroids for Skin Reactions to Continuous Glucose Monitoring System, Among Children and Youth With Type 1 Diabetes Mellitus: Case Series
- ClinicalTrials.gov ID
- NCT03594565
- Acronym / sponsor ID
- 0277-16-ASF
- Conditions
- T1DM, Hypersensitivity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 20 Jul 2018 (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.
Background Type 1 diabetes mellitus is a chronic metabolic disorder that presents a significant set of challenges to the patient, their family and the physician. Near normoglycemia is associated with a reduced risk of microvascular and macrovascular complications in type 1 diabetes mellitus but is difficult to achieve despite considerable effort from patients and healthcare providers . Furthermore, episodes of hypoglycemia are frequent and may endanger life acutely. Subcutaneous glucose monitoring systems (CGMS), also called sensors that continuously measure interstitial fluid glucose levels have become available recently, and approved for use in children. CGMS has made it possible to assess the patterns and trends of blood glucose and the substantial variability in glucose excursions in the population of type 1 diabetes, and to prevent severe hypoglycemic episodes. The benefits of this technology are most apparent with near continuous wear of the sensors and is incorporated into the day to day management of the individual's diabetes . These devices provide patients with information regarding postprandial and overnight glucose profiles that are rarely, if ever, obtained with conventional self monitoring of blood glucose using home glucose meters .
Skin reactions CGM systems measure the glucose content of interstitial fluid , using an electrochemical enzymatic sensor, which is accessed by a needle sensor inserted subcutaneously. The CGMS is compromised of a disposable subcutaneous glucose-sensing catheter connected by a cable to a pager sized glucose monitor . Problems related associated to skin irritation and sensor adhesiveness in these young children presents challenges to daily use of the CGMS. In the study conducted by Englert et al, for the Diabetes Research in Children (Directnet) Study Group - three primary factors that contributed to reduced CGM use were identified: the limited body surface area in smaller children, ambient temperature and humidity, as well as the type and duration of physical activity. A study conducted in Israel, by our group, demonstrated only 30% consistant use of the system, partly due to skin reactions . In our cohort, thirty participants of the CGMS group (36.1 %) had signs of local reaction to the RT-CGMS insertion. Mild-to severe local redness was reported in 19 % of patients and hyperpigmentation in 17 %. Skin reactions were among the reasons for discontinuation of CGMS (2/51 participants, 3.9 %).
The use of Local Fluticasone for dermatological use Fluticasone propionate - the first carbothioate corticosteroid - has been classified as a potent anti-inflammatory drug for dermatological use. It is available as cream and ointment formulations for the acute and maintenance treatment of patients with dermatological disorders such as atopic dermatitis, psoriasis and vitiligo. This glucocorticoid is characterized by high lipophilicity, high glucocorticoid receptor binding and activation, and a rapid metabolic turnover in skin. Several clinical trials demonstrate a low potential for cutaneous and systemic side-effects . Even among paediatric patients with atopic dermatitis, fluticasone propionate proved to be safe and effective. These pharmacological and clinical properties are reflected by the high therapeutic index of this glucocorticoid. The same drug is also available as a nasal spray ,for cases of allergic rhinitis.
The use of fluticasone in spray, sprayed on the location of CGMS insertion, prior to insertion to prevent adverse skin reactions in patients with type 1 DM using CGMS devices has not been addressed in the literature.
Hypothesis :
Minimizing skin irritation may significantly improve duration of use and tolerability of CGM devices by young children, as well a in young adults. The Investigators assumed that the simple use of a spray, which will not decrease the adhesiveness of the sensor, may improve use .
Methods Children whose parents had difficulty with CGMS due to irritation, redness were offered to use Flixonase (FLUTICASONE PROPIONATE), with an approval form 29ג, indicating it is not approved for this specific diagnosis .
The investigators followed those patients for improvement and possible local side effects.
Study population Every patient, treated by the pediatric and adolescents diabetes mellitus interdisciplinary service , Assaf Haroffe Medical Center , who experienced local reaction at the site of CGMS was offered this medical option .
Charts were reviewed for response . total participants - 15
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Local steroids prior to CGMS insertion | Experimental | Drug: Fluticasone Propionatetopical spraying of fluticasone propionate nasal spray (nsFP) on the skin area of CGMS placement prior to sensor insertion in a group of pediatric T1D patients who had mild to severe local skin reactions to CGMS adhesives. Dosage: 2 puffs. |
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 1-20 years
- Local skin reaction to CGMS indicating local or systemic management.
Key exclusion criteria (1 listed)
- Patients who were offered nsFP but did not actually use it.
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 |
|---|---|---|
| Fluticasone PropionateLocal Fluticasone Propionate use prior to continuous glucose monitoring system insertion | Drug | Local steroids prior to CGMS insertion |
Primary outcome
Difference in skin irritation before and after regular application of nsFP according to the modified Draize scale.
Time frame: 2 years from patient first enrollment
Erythema and edema were assessed for adhesive and sensor-insertion areas on a 4-point scale, with total score ≤3 defined as mild, 4-5 as moderate, and 6-8 as severe.
4 secondary outcomes
Change in BMI SDS
Time frame: 6 months after nsFP use
Change in height SDS 6 months after nsFP use
Time frame: 6 months after nsFP use.
Change in mean glucose 6 months after nsFP use
Time frame: 6 months after nsFP use.
Change in glycated hemoglobin 6 months after nsFP use
Time frame: 6 months after nsFP use.
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 13 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluticasone Propionate in people with T1DM and Hypersensitivity, run by Assaf-Harofeh Medical Center.
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 2 inclusion and 1 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Difference in skin irritation before and after regular application of nsFP according to the modified Draize scale. (time frame: 2 years from patient first enrollment). 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 13 Aug 2019.