Induce (Intellin Diabetic Foot) Feasibility Study

Natalie Garratt

Status: Completed

Conditions: Healed Ulcer

Treatments: Other: Intellin smart phone application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03591081

S18DIAB04-S

Details and patient eligibility

About

This is a novel feasibility study to test the participant acceptance and usability of a specifically designed smart phone app. It will also explore the effects of smart phone technology in improving self-referrals into the diabetic foot ulcer (DFU) service. Furthermore, it will be explored if this increase in self-referrals will influence the outcome of people with diabetes who have recently had a healed foot ulceration.

Full description

The rationale behind this study is if the investigators can introduce a new technology (a smart phone app) which is acceptable to patients, engages them and prompts people to take preventative health behaviours then the investigators may be able to influence the low rates of appropriate self-referral. There is evidence that links poor glycaemic control and hypertension to DFUs, so engagement in these areas of wider diabetes management needs to be reviewed, the latest National Diabetes Audit (NDA) shows only 20% of people with Type 1 and 42% of people with Type 2 diabetes achieve the 3 NICE standards for HbA1c, BP and cholesterol. In addition, healthcare providers are being asked to investigate new systems that may increase patient engagement with and the uptake of the NICE 8 annual care processes. The latest NDA shows only 40% of patients with type 1 and 60% of patients with type 2 diabetes currently have all 8 .

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • 18 years of age will be screened to meet the eligibility criteria:

  • Consultant or GP diagnosis of diabetes mellitus (Type I or II) , documented on the electronic patient record with HbA1C greater than 48mmol/mol
  • History of a recent diabetes foot ulcer defined as being eligible for the national diabetes foot audit and classified as healed for at least 4 weeks and no more than 12 weeks
  • Able to provide informed consent
  • Has no reasons that they could not be part of the study for 12 months such as moving out the area for attending appointments or short life expectancy from a diagnosed illness
  • Owns a smart phone

Exclusion criteria

• No smart phone
• Comorbidity such as poor eyesight which limits the use of smart phone
• Participation in an interventional study within the last 30 days
• Critical illness that prevents participating for a period of time

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Intellin smart phone application

Other group

Description:

Participants will download a smart phone app, the platform will give the patients daily hints and tips on how to look after their feet.

Treatment:

Other: Intellin smart phone application