Diabetes Mellitus, Type 2NCT03908762
mHealth Titration and Management
A study testing iSage App with connected glucometer and Magnet in people with Diabetes Mellitus, Type 2 and Diabetic Complication, run by Amalgam Rx, Inc. at 1 site in United States.
Trial summary
The principal objective of this application is to improve glycemic control of diabetic patients treated with basal insulin through use of an innovative, FDA-cleared smartphone-based insulin titration application connected to Bluetooth enabled glucose meters. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Complication
- What is being tested?
- iSage App with connected glucometer and Magnet
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to Mar 2020
- Phase
- Interventional
- 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 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- T2DM (WHO criteria) treated with basal insulin (glargine, detemir, degludec)
- HgbA1c 8 or above
- GFR >60 ml/min within the last 12 months
- English speaking, informed consent
- Has an Android or iOS based compatible smartphone (iOS 9.0 or above; Android 4.4 or above)
- Currently performs at least 3 fasting fingerstick glucose measurements/week
- Have a PCP within the KU Health System
Who cannot join
- Diagnosis of hypoglycemic unawareness within 6 months of enrollment
- Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment
- Recent (within the last 6 months)/current use of non-topical steroids
- Insulin requirements in excess of 1U/kg per day
- Use of pioglitazone or another thiazolidinedione (TZD)
- In the opinion of the provider, HgbA1c goals should adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cray Diabetes Self-Management Center
Kansas City, Kansas, 66160
Teri Lavenbarg, 913-588-6022, tlavenbarg@kumc.edu
David Robbins
About this study
Official title: Use of a Digital Therapeutic and Connected Devices to Support Insulin Titration
The principal objective of this application is to improve glycemic control of diabetic patients treated with basal insulin through use of an innovative, FDA-cleared smartphone-based insulin titration application connected to Bluetooth enabled glucose meters. iSage Rx (isageapp.com) allows providers to prescribe basal insulin treatment plans to patients and manages basal insulin doses utilizing clinically proven algorithms. In this pilot study, we hypothesize that this user-friendly application and seamless data capture will improve glycemic control (achieve HgbA1c <7%) and reduce the frequency and severity of hypoglycemia. Exploratory measures will include healthcare resource utilization and patient and provider satisfaction. The basal insulin titration algorithms used in iSage have had thousands of user-years' experience in FDA-mandated, closely supervised clinical trials, both for long-acting insulins (e.g., Lantus, Levemir) that have been available for a long time and for the newer ultra-long-acting ones (e.g., Tresiba, Toujeo). However, the effectiveness of iSage with a connected glucose meter has not been studied in a "real world" clinical environment. Broad use of such an application and connected devices will, we believe, prove to be cost-effective, favor early and appropriate prescription of insulin, reduce provider effort, shorten time to achieve glycemic goals, and simplify the transition to basal insulin therapy.
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Complication
- Being tested
- iSage App with connected glucometer, Magnet
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSage App with connected glucometerDevice
Providers prescribe an insulin dosing plan to patients and provide them with a connected glucometer. The patient's plan is administered through a mobile application. In addition, patients receive education and guidance on insulin administration.
MagnetBehavioural
Patients are given a refrigerator magnet with an insulin titration algorithm and are asked to follow the instructions on the magnet.
| Study group | Role | What they receive |
|---|---|---|
| iSage | Experimental | The provider will choose a treatment algorithm embedded within the app and set the parameters to make insulin dose adjustments no less frequently than every 7 days. The app is downloaded by the patient while in the examination room, and the patient is instructed to perform daily fasting glucose fingerstick measurements and follow the app's recommendations for insulin adjustment. Data on telephone or visit contact with a healthcare provider will be collected via the EMR. Hypoglycemic events (defined as blood glucose <70 mg/dl, measured or perceived) are recorded in the iSage application as well as patient report. Providers are asked to review the patients transmitted blood sugar logs as necessary, and those reviews are recorded. Return visits are managed by the HCP and will be logged as resource utilization. Receives: Device: iSage App with connected glucometer |
| Conventional Management | Active comparator | Our clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet. In the case of glargine or detemir (Basaglar, Lantus, Levemir) adjustments of 1 unit of insulin/day are made until the fasting blood sugars (2 of 3 consecutive values) are 80-130 mg/dl. In the instance of Toujeo or Tresiba, adjustments of 2 units are made every 5 days. Volunteers will have meters downloaded (or interviewed where necessary) to obtain data on fasting blood sugar and episodes of hypoglycemia (perceived or measured <70 mg/dl). The PCP is free to request glucose logs and set return appointments as needed to manage the patient. Receives: Behavioral: Magnet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1C
Mean and Median Change from Baseline
Measured: 3 Months
Secondary outcomes (2)
A1C in Target
Percentage of patients with an A1C < 7
Measured: Baseline to 3 months
Rate of Hypoglycemia
Percentage of glucose readings <70
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Jan 2019
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amalgam Rx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kansas City Area Life Sciences Institute, Inc., University of Kansas, LifeScan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908762
- Sponsor's protocol ID
- 00142758
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 9 Apr 2019
- 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 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Digital Therapeutic and Connected Devices to Support Insulin Titration
- ClinicalTrials.gov ID
- NCT03908762
- Acronym / sponsor ID
- 00142758
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Amalgam Rx, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kansas City Area Life Sciences Institute, Inc., University of Kansas, LifeScan
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 9 Apr 2019 (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.
The principal objective of this application is to improve glycemic control of diabetic patients treated with basal insulin through use of an innovative, FDA-cleared smartphone-based insulin titration application connected to Bluetooth enabled glucose meters. iSage Rx (isageapp.com) allows providers to prescribe basal insulin treatment plans to patients and manages basal insulin doses utilizing clinically proven algorithms. In this pilot study, we hypothesize that this user-friendly application and seamless data capture will improve glycemic control (achieve HgbA1c <7%) and reduce the frequency and severity of hypoglycemia. Exploratory measures will include healthcare resource utilization and patient and provider satisfaction. The basal insulin titration algorithms used in iSage have had thousands of user-years' experience in FDA-mandated, closely supervised clinical trials, both for long-acting insulins (e.g., Lantus, Levemir) that have been available for a long time and for the newer ultra-long-acting ones (e.g., Tresiba, Toujeo). However, the effectiveness of iSage with a connected glucose meter has not been studied in a "real world" clinical environment. Broad use of such an application and connected devices will, we believe, prove to be cost-effective, favor early and appropriate prescription of insulin, reduce provider effort, shorten time to achieve glycemic goals, and simplify the transition to basal insulin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iSage | Experimental | Device: iSage App with connected glucometerThe provider will choose a treatment algorithm embedded within the app and set the parameters to make insulin dose adjustments no less frequently than every 7 days. The app is downloaded by the patient while in the examination room, and the patient is instructed to perform daily fasting glucose fingerstick measurements and follow the app's recommendations for insulin adjustment. Data on telephone or visit contact with a healthcare provider will be collected via the EMR. Hypoglycemic events (defined as blood glucose <70 mg/dl, measured or perceived) are recorded in the iSage application as well as patient report. Providers are asked to review the patients transmitted blood sugar logs as necessary, and those reviews are recorded. Return visits are managed by the HCP and will be logged as resource utilization. |
| Conventional Management | Active comparator | Behavioral: MagnetOur clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet. In the case of glargine or detemir (Basaglar, Lantus, Levemir) adjustments of 1 unit of insulin/day are made until the fasting blood sugars (2 of 3 consecutive values) are 80-130 mg/dl. In the instance of Toujeo or Tresiba, adjustments of 2 units are made every 5 days. Volunteers will have meters downloaded (or interviewed where necessary) to obtain data on fasting blood sugar and episodes of hypoglycemia (perceived or measured <70 mg/dl). The PCP is free to request glucose logs and set return appointments as needed to manage the patient. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- T2DM (WHO criteria) treated with basal insulin (glargine, detemir, degludec)
- HgbA1c 8 or above
- GFR >60 ml/min within the last 12 months
- English speaking, informed consent
- Has an Android or iOS based compatible smartphone (iOS 9.0 or above; Android 4.4 or above)
Key exclusion criteria (6 listed)
- Diagnosis of hypoglycemic unawareness within 6 months of enrollment
- Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment
- Recent (within the last 6 months)/current use of non-topical steroids
- Insulin requirements in excess of 1U/kg per day
- Use of pioglitazone or another thiazolidinedione (TZD)
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 |
|---|---|---|
| iSage App with connected glucometerProviders prescribe an insulin dosing plan to patients and provide them with a connected glucometer. The patient's plan is administered through a mobile application. In addition, patients receive education and guidance on insulin administration. | Device | iSage |
| MagnetPatients are given a refrigerator magnet with an insulin titration algorithm and are asked to follow the instructions on the magnet. | Behavioural | Conventional Management |
Primary outcome
Change in A1C
Time frame: 3 Months
Mean and Median Change from Baseline
2 secondary outcomes
A1C in Target
Time frame: Baseline to 3 months
Rate of Hypoglycemia
Time frame: Baseline to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSage App with connected glucometer and Magnet in people with Diabetes Mellitus, Type 2 and Diabetic Complication, run by Amalgam Rx, Inc. 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 6 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: status not confirmed, as of the sponsor's last update on 9 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in A1C (time frame: 3 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 9 Apr 2019.