Health TrialsbyHealthPanel

Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes

ConditionsType 1 Diabetes (T1D)Latent Autoimmune Diabetes in Adult (LADA)Pancreatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorYale University

About this trial

The challenges of living with type 1 diabetes often stand in the way of getting enough exercise. Continuous blood sugar monitoring has revolutionized type 1 diabetes care but remains underutilized to sustainably support exercise and related behaviors. This remote participation-based research will develop a mobile application that delivers personalized encouragement and data-driven health insights based upon patterns in blood sugar, exercise, mood, and sleep, to assist people with type 1 diabetes in exercising more frequently and confidently. You do not need to live in Connecticut to participate, as there will be no required in-person visits during the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

30-65 years old inclusive

Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)

Less than 1.0 exercise sessions per week

Smartphone ownership

Disqualifiers

Diabetic ketoacidosis not clearly related to pump site failure in past 6 months

>1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months

A1c ≥10.0%

Resting blood pressure >160mmHg systolic or >100 mmHg diastolic.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Exercise program

    Behavioral

    Participants will receive a free Garmin smartwatch and a free program membership providing exercise coaching + personalized feedback about the relationship among their insulin, carbohydrates, exercise, sleep, and blood sugar.

  • Self-monitoring

    Behavioral

    Wear a fitness watch and keep daily health diary

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Self-MonitoringActive comparator 1 intervention
Group B: Exercise programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Weekly exercise duration

Minutes/week. Measured by blinded hip watch and periodic interviews. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.

Time frame
20 weeks

Secondary outcomes

1

Weekly exercise volume

Kilocalories, determined by minutes and intensity. Measured by blinded hip watch and periodic interviews. A person achieving 150 minutes per week will achieve around 1,200 - 2,000 kilocalories per week.

Time frame
20 weeks
2

Weekly exercise days

Days/week. Measured by blinded hip watch and periodic interviews. 0 days/week is the lowest value, 3-7 days/week meets clinically recommended amounts.

Time frame
20 weeks
3

Glucose

The measurable range is 20-400 mg/dL. It is quantified by average levels, time above/within/below the target range of 70-180 mg/dL, and coefficient of variation.

Time frame
20 weeks
4

Body mass index

Calculated from body weight and height (kilograms per meters squared)

Time frame
20 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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