Diabetes MellitusGEMAppNCT02336217
Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations
A study testing Experimental Group instructions for glucose management via App in people with Diabetes Mellitus, run by Marshall University at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine the utility of an algorithm for better glucose control in diabetic patients communicated via an App to help improve outcomes and reduce urgent care and ER visits as well as improve A1C and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Experimental Group instructions for glucose management via App
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or type 2 diabetes on therapeutic treatment other than just lifestyle changes
- Treatment by Marshall Internal Medicine Department
- Have a smart phone
- At least 6th grade education level
Who cannot join
- Pregnant women
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to determine the utility of an algorithm for better glucose control in diabetic patients communicated via an App to help improve outcomes and reduce urgent care and ER visits as well as improve A1C and quality of life.
Read the detailed description
The aim of the study is to determine the impact of GEM (glycemic emergency management device-app) in reducing the frequency and severity of hypoglycemia episodes in persons with diabetes. Other objectives include: to determine whether the GEM system leads to improved glucose control (as measured by HbA1c) during participation in the pilot, to determine whether the GEM can be used as a cost effective solution in reducing ER and urgent care visits, to determine the difference in ADDQOL scores between persons with a functioning GEM system and those with a placebo device. The Study hypothesis is as follows: There wil be significant differences in number of hypoglycemic events, ER and urgent care visits, A1C, as well as quality of life as measured by the ADDQOL scores between persons with diabetes who have the functioning GEM device in their smart phones and those that do not have such a device installed in their smart phones.
The purpose of this pilot study is to determine the utility of this application to help improve outcomes and reduce urgent care and ER visits as well as improve A1C and quality of life in persons with diabetes. This approach may be a paradigm shift in the rapidly detecting, monitoring, intervening and managing the acute diabetic complications of hypoglycemia, hyperglycemia and diabetic ketoacidosis. Spiraling health care costs are a major concern to the economy of the US. New measures have been introduced in the Affordable Care Act to improve the efficiency of the health care delivery system. There is more emphasis on preventive health care services. Our study is a step in that direction since it utilizes existing smart phone technology and converts it into a medical device which can be of invaluable help to the patient.
- Conditions
- Diabetes Mellitus
- Being tested
- Experimental Group instructions for glucose management via App, Placebo Comparator general instructions
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group instructions for glucose management via AppOther
The Experimental Group receives individually calculated instructions for glucose management management via the App.
Placebo Comparator general instructionsOther
The Placebo Comparator Group receives general instructions but not the complete management algorithm
| Study group | Role | What they receive |
|---|---|---|
| Functioning App | Experimental | These subjects have the complete algorithm functioning and communicated via the App. Receives: Other: Experimental Group instructions for glucose management via App |
| Non-functioning App | Placebo comparator | These subjects receive routine instructions via the App but not the complete algorithm. Receives: Other: Placebo Comparator general instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypoglycemic episodes
Measured: 6 months
Secondary outcomes (3)
A1c level
Measured: 6 months
Number of Emergency Room, Urgent Care, or Walk-In Clinic visits
Measured: 6 months
ADDQOL score
Quality of life assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Driscoll, MD, Marshall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336217
- Sponsor's protocol ID
- 574049
- Acronym
- GEMApp
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2014
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations
- ClinicalTrials.gov ID
- NCT02336217
- Acronym / sponsor ID
- GEMApp / 574049
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Jan 2015 (estimated)
- 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.
The purpose of this pilot study is to determine the utility of an algorithm for better glucose control in diabetic patients communicated via an App to help improve outcomes and reduce urgent care and ER visits as well as improve A1C and quality of life.
Detailed description
The aim of the study is to determine the impact of GEM (glycemic emergency management device-app) in reducing the frequency and severity of hypoglycemia episodes in persons with diabetes. Other objectives include: to determine whether the GEM system leads to improved glucose control (as measured by HbA1c) during participation in the pilot, to determine whether the GEM can be used as a cost effective solution in reducing ER and urgent care visits, to determine the difference in ADDQOL scores between persons with a functioning GEM system and those with a placebo device. The Study hypothesis is as follows: There wil be significant differences in number of hypoglycemic events, ER and urgent care visits, A1C, as well as quality of life as measured by the ADDQOL scores between persons with diabetes who have the functioning GEM device in their smart phones and those that do not have such a device installed in their smart phones.
The purpose of this pilot study is to determine the utility of this application to help improve outcomes and reduce urgent care and ER visits as well as improve A1C and quality of life in persons with diabetes. This approach may be a paradigm shift in the rapidly detecting, monitoring, intervening and managing the acute diabetic complications of hypoglycemia, hyperglycemia and diabetic ketoacidosis. Spiraling health care costs are a major concern to the economy of the US. New measures have been introduced in the Affordable Care Act to improve the efficiency of the health care delivery system. There is more emphasis on preventive health care services. Our study is a step in that direction since it utilizes existing smart phone technology and converts it into a medical device which can be of invaluable help to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functioning App | Experimental | Other: Experimental Group instructions for glucose management via AppThese subjects have the complete algorithm functioning and communicated via the App. |
| Non-functioning App | Placebo comparator | Other: Placebo Comparator general instructionsThese subjects receive routine instructions via the App but not the complete algorithm. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 or type 2 diabetes on therapeutic treatment other than just lifestyle changes
- Treatment by Marshall Internal Medicine Department
- Have a smart phone
- At least 6th grade education level
Key exclusion criteria (2 listed)
- Pregnant women
- Cognitive impairment
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 |
|---|---|---|
| Experimental Group instructions for glucose management via AppThe Experimental Group receives individually calculated instructions for glucose management management via the App. | Other | Functioning App |
| Placebo Comparator general instructionsThe Placebo Comparator Group receives general instructions but not the complete management algorithm | Other | Non-functioning App |
Primary outcome
Number of hypoglycemic episodes
Time frame: 6 months
3 secondary outcomes
A1c level
Time frame: 6 months
Number of Emergency Room, Urgent Care, or Walk-In Clinic visits
Time frame: 6 months
ADDQOL score
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group instructions for glucose management via App in people with Diabetes Mellitus, run by Marshall University 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 2 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: under way, not looking for participants, as of the sponsor's last update on 23 May 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of hypoglycemic episodes (time frame: 6 months). 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 23 May 2025.