N/A
Completed N=80
A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
Source: ClinicalTrials.gov NCT03224234 ↗Enrolled (actual)
80
Serious AEs
5.1%
Results posted
Jan 2021
Primary outcomePrimary: Number of Insulin Injection Irregularities. — 22.22; 23.10 irregularities
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Insulin Injection Irregularities. |
22.22; 23.10 | — |
| PRIMARY Number of Participants Experiencing Insulclock Device Malfunctions |
5; 2 | — |
| SECONDARY Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score. |
15.45; 15.18 | — |
| SECONDARY Change in Diabetes Related Quality of Life (DRQoL) Scores. |
— | — |
| SECONDARY Change in Mean HbA1c. |
-0.9; -0.73 | — |
| SECONDARY Number of Episodes of Hypoglycemia. |
29; 25 | — |
| SECONDARY Number of Episodes of Severe Hypoglycemia. |
1; 1 | — |
| SECONDARY Change in Daily Fasting Glucose Profile Averages. |
142.24; 146.54 | — |
| SECONDARY Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile. |
— | — |
| SECONDARY Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT03224234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.