DiabetesNCT03224234
A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
A study testing Insulclock with feedback and Insulclock without feedback in people with Diabetes, run by Emory University at 1 site in United States.
Trial summary
Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Insulclock with feedback and Insulclock without feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 18 Sep 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 80 years
- Diagnosis of T2D
- Screening HbA1c ≥ 7.5% to ≤ 11%
- Continuous treatment with one or more oral antidiabetic agents, for at least 2 months
- Continuous treatment with daily basal insulin (NPH, glargine U100 or detemir), for at least 2 months, (insulin dose ≤0.5U/Kg/day)
- If patients are on combination therapy of basal insulin and GLP1-RA, the dose of GLP-1 RA should be stable for the past three months.
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- Owns a smartphone - Apple iPhone, Samsung Galaxy models
- Signed, informed consent and HIPAA documentation
- Subjects' ability to self-administer insulin, use the device and complete subject reported outcomes instruments
- Subjects' ability \& willingness to adhere to and be compliant with study protocol
Who cannot join
- Refusal or inability to give informed consent to participate in the study
- Subject is currently taking or was treated with glargine U300 insulin, degludec, insulin dose greater than 0.5 U/kg/day during the previous three months
- Subject treated with prandial insulin or premixed formulations during the previous three months
- Impaired renal function as shown by, but not limited to, eGFR < 30 ml/min.
- Muscle weakness or hemiparesis related to previous stroke or myelopathy resulting in incoordination, muscle weakness and inability to use pen device for insulin administration
- History of diabetic ketoacidosis during the previous 6 months
Show all 19Show fewer
- Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times the upper limit of the normal range
- History of hypoglycemia unawareness
- Pregnancy or lactation
- Known hypersensitivity to insulin glargine or any of the components
- Any malignancy within the last 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ
- Current drug addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
- Diagnosis of dementia
- Severe gastrointestinal diseases including gastroparesis
- Cardiac status NYHA III-IV
- Acute infection
- Patients on or planning to receive long term oral or injectable steroid treatment for greater than 10 days
- Patient schedule to undergo general surgery during the next 6 months
- Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Clinic, Emory University Hospital (non-CRN), Emory University Hospital Clinical Research Network, Emory University Hospital Midtown, Grady Health System (non-CRN)
Atlanta, Georgia, 30322
About this study
Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming.
Read the detailed description
Diabetes is arguably the most urgent healthcare challenge of the 21st century. Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming. The Insulclock's real time memory and alert system are likely to improve treatment adherence, patient's satisfaction, and quality of life measures, which may improve glycemic control in insulin treated patients with Type 2 Diabetes.
- Conditions
- Diabetes
- Being tested
- Insulclock with feedback, Insulclock without feedback
- Keywords
- Uncontrolled Type 2 Diabetes, Insulclock, Electronic device, Alarm system
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulclock with feedbackDevice
Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
Insulclock without feedbackDevice
Not feedback on insulin administration.
| Study group | Role | What they receive |
|---|---|---|
| Insulclock with feedback (Group A) | Experimental | Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm. Receives: Device: Insulclock with feedback |
| Insulclock without feedback (Group B) | Active comparator | Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm. Receives: Device: Insulclock without feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Insulin Injection Irregularities.
Number of insulin injection irregularities (omission, mistiming and dosing) will be registered on the Insulclock device, and data will be retrieved during each clinic visit to monitor treatment adherence.
Measured: Week 0 through week 24.
Number of Participants Experiencing Insulclock Device Malfunctions
Number of participants experiencing Insulclock device malfunctions are reported
Measured: Up to 12 weeks
Secondary outcomes (8)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.
The amplitude of the score on the DTSQc gives the degree of change in satisfaction while the direction (positive or negative) will provide guidance on the preference of one device over the other. DTSQc contains eight items scored on 7-point scales; scores range from +3 = much more satisfied now to -3 = much less satisfied now, with 0 (midpoint), representing no change.
Measured: Baseline, 24 weeks
Change in Diabetes Related Quality of Life (DRQoL) Scores.
DRQoL is a composite score, consisting of a standardized and unweighted Insulin Treatment Experience Questionnaire Score (ITEQ), and Problem Areas in Diabetes (PAID) questionnaire score. ITEQ includes 7 domains: leisure activities (4 items), psychological barriers (2 items), handling (5 items), diabetes control (6 items), dependence (5 items), weight control (3 items), sleep (2 items); + 1 additional item assigned to assess overall satisfaction with current insulin therapy regimen. The PAID contains 20 items that describe negative emotions related to diabetes commonly experienced by patients with diabetes. Each question has five possible answers with a value from 0 to 4, with 0 representing "no problem" and 4 "a serious problem". The scores are added up and multiplied by 1.25, generating a total score between 0 - 100.
Measured: Baseline, 24 weeks
Change in Mean HbA1c.
HbA1c is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The test is limited to a three-month average because the lifespan of a red blood cell is four months (120 days). Change in mean HbA1cas will be measure and recorded to monitor glycemic control.
Measured: Baseline, 24 weeks
Number of Episodes of Hypoglycemia.
Number of episodes of hypoglycemia will be recorded. For this study, symptomatic hypoglycemia is defined as an event with typical symptoms (i.e., sweating, palpitation, and feeling of hunger) with or without confirmation by plasma glucose <54 mg/dl (3.9 mmol/L).
Measured: Week 0 through week 24.
Number of Episodes of Severe Hypoglycemia.
Number of episodes of severe hypoglycemia will be recorded.Severe hypoglycemia is defined as episodes necessitating assistance and associated with measured plasma glucose < 40 mg/dl (2.2 mmol/L), or with prompt recovery after administration of carbohydrates, glucagon, or other resuscitative actions.
Measured: Week 0 through week 24.
Change in Daily Fasting Glucose Profile Averages.
Daily fasting glucose profile averages will be recorded to monitor glycemic control.
Measured: Week 0 through week 24.
Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile.
SMBG refers to home blood glucose testing for people with diabetes. 7-point SMBG profile include fasting, before meals, 2 hours after meals, and bedtime.
Measured: 3 to 5 days prior to randomization, up to 24 weeks.
Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score
The DQLCTQ-R is a 57-item scale that comprises 8 dimensions: physical function, energy/fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility, and frequency of symptoms.
Measured: Baseline, 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start29 Nov 2017
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Insulcloud S.L.
- Responsible party
- Principal investigator, Guillermo Umpierrez, MD, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224234
- Sponsor's protocol ID
- IRB00094393
- Status last verified
- Jan 2021
- First submitted
- 19 Jul 2017
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03224234
- Acronym / sponsor ID
- IRB00094393
- Conditions
- Diabetes
- Keywords
- Uncontrolled Type 2 Diabetes, Insulclock, Electronic device, Alarm system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Insulcloud S.L.
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming.
Detailed description
Diabetes is arguably the most urgent healthcare challenge of the 21st century. Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming. The Insulclock's real time memory and alert system are likely to improve treatment adherence, patient's satisfaction, and quality of life measures, which may improve glycemic control in insulin treated patients with Type 2 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).
| Arm | Type | Receives |
|---|---|---|
| Insulclock with feedback (Group A) | Experimental | Device: Insulclock with feedbackParticipants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm. |
| Insulclock without feedback (Group B) | Active comparator | Device: Insulclock without feedbackParticipants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18 to 80 years
- Diagnosis of T2D
- Screening HbA1c ≥ 7.5% to ≤ 11%
- Continuous treatment with one or more oral antidiabetic agents, for at least 2 months
- Continuous treatment with daily basal insulin (NPH, glargine U100 or detemir), for at least 2 months, (insulin dose ≤0.5U/Kg/day)
Key exclusion criteria (19 listed)
- Refusal or inability to give informed consent to participate in the study
- Subject is currently taking or was treated with glargine U300 insulin, degludec, insulin dose greater than 0.5 U/kg/day during the previous three months
- Subject treated with prandial insulin or premixed formulations during the previous three months
- Impaired renal function as shown by, but not limited to, eGFR < 30 ml/min.
- Muscle weakness or hemiparesis related to previous stroke or myelopathy resulting in incoordination, muscle weakness and inability to use pen device for insulin administration
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 |
|---|---|---|
| Insulclock with feedbackDaily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. | Device | Insulclock with feedback (Group A) |
| Insulclock without feedbackNot feedback on insulin administration. | Device | Insulclock without feedback (Group B) |
Primary outcome
Number of Insulin Injection Irregularities.
Time frame: Week 0 through week 24.
Number of insulin injection irregularities (omission, mistiming and dosing) will be registered on the Insulclock device, and data will be retrieved during each clinic visit to monitor treatment adherence.
Number of Participants Experiencing Insulclock Device Malfunctions
Time frame: Up to 12 weeks
Number of participants experiencing Insulclock device malfunctions are reported
8 secondary outcomes
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.
Time frame: Baseline, 24 weeks
Change in Diabetes Related Quality of Life (DRQoL) Scores.
Time frame: Baseline, 24 weeks
Change in Mean HbA1c.
Time frame: Baseline, 24 weeks
Number of Episodes of Hypoglycemia.
Time frame: Week 0 through week 24.
Number of Episodes of Severe Hypoglycemia.
Time frame: Week 0 through week 24.
Change in Daily Fasting Glucose Profile Averages.
Time frame: Week 0 through week 24.
Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile.
Time frame: 3 to 5 days prior to randomization, up to 24 weeks.
Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score
Time frame: Baseline, 24 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Guillermo Umpierrez, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulclock with feedback and Insulclock without feedback in people with Diabetes, run by Emory 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 10 inclusion and 19 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 22 Jan 2021. 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 22 Jan 2021). 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?
Number of Insulin Injection Irregularities. (time frame: Week 0 through week 24.). The study lists 2 primary outcomes in all. 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 22 Jan 2021.